Sophic Logo gordian knotLung Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in May 2026


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1: Summary data from new trials identified for Lung Cancer.


Overview

Number of Trials: 16

These 16 trials span diverse cancer types, with a strong focus on lung cancer (NSCLC, SCLC, transformed SCLC) and other solid tumors including colorectal, breast, gastroesophageal, pancreatic, ovarian, and neuroendocrine cancers. Interventions range from novel immunotherapies (PD-1/PD-L1 inhibitors, CAR-T, bispecific antibodies), targeted therapies (MET inhibitors, EGFR inhibitors, antibody-drug conjugates), and combination regimens (chemotherapy plus immunotherapy) to supportive care models (palliative care, financial navigation, psychosocial interventions). Several trials test first-in-human or early-phase agents targeting specific biomarkers (CLDN18.2, DLL3, MET exon 14 skipping). Trials emphasize precision medicine with genomic selection, quality of life, and innovative delivery methods such as photoimmunotherapy and adoptive cell therapy.

Common Criteria Across Trials

Common Inclusion

  • Age 18 years or older
  • Histologically or cytologically confirmed cancer diagnosis
  • Measurable disease per RECIST v1.1
  • ECOG performance status 0-2
  • Adequate organ function (hematologic, hepatic, renal)
  • Life expectancy greater than 12 weeks
  • Prior standard of care therapy or progression on prior treatment
  • Negative pregnancy test for women of childbearing potential
  • Agreement to use effective contraception

Common Exclusion

  • Active or untreated brain metastases or leptomeningeal disease
  • Active autoimmune disease requiring systemic treatment
  • History of interstitial lung disease or pneumonitis
  • Uncontrolled intercurrent illness or infection
  • Significant cardiovascular disease within 6 months
  • Prior organ or stem cell transplantation
  • Pregnant or breastfeeding
  • Active hepatitis B, hepatitis C, or HIV with active replication
  • History of other malignancy within 2-5 years
  • QTc prolongation or significant cardiac arrhythmia
  • Recent major surgery within 4 weeks
  • Use of systemic corticosteroids or immunosuppressive agents

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT07296887

Implement and Evaluate the CARE Tool in a Randomized Trial

Organization/Sponsor: Washington University School of Medicine


Example patient: A 62-year-old English-speaking patient with newly diagnosed lung cancer receiving treatment at Siteman Cancer Center who is cognitively intact and able to provide informed consent.

Phase N/A

Interventions

  • Behavioral: CARE Tool Training
    Summary: Training intervention to enhance care strategies and patient support coordination for cancer patients. Aims to improve patient outcomes through enhanced care delivery mechanisms. Source: Summary of Web Search.
  • Behavioral: CARE Tool
    Summary: Web-based tool providing information on cancer care costs, health insurance, and financial resources. Enhances patient decision-making and knowledge while reducing anxiety related to treatment costs. Source: Summary of Web Search.
  • Behavioral: Financial education information
    Summary: Educational intervention providing financial information to reduce barriers to cancer screening and treatment. Improves patient understanding of financial burdens and resources available. Source: Summary of Web Search, NCI Thesaurus.

Key Inclusion

  • Age 18 and over
  • Primary or recurrent diagnosis of lung cancer in the last 12 months
  • Receiving cancer treatment from Siteman Cancer Center, Delbert Day Cancer Institute, or Alton Memorial Hospital
  • Self-reported ability to read and speak English

Key Exclusion

  • Under the age of 18
  • Not diagnosed with lung cancer within the previous 12 months from recruitment
  • Not receiving care at specified cancer centers
  • Cannot give consent due to cognitive or emotional barriers

NCT07391956

TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer Genomic-based

Organization/Sponsor: Icahn School of Medicine at Mount Sinai


Example patient: A 62-year-old Spanish-speaking woman with advanced pancreatic cancer (ECOG 1) residing in Queens, hospitalized once in the past 4 months, with no driver mutations and no prior palliative care visits.

Phase N/A

Interventions

  • Behavioral: Community Health Worker
    Summary: Frontline public health workers who provide education, navigation, and tailored support to increase healthcare access and improve health equity in underserved communities (NCI Thesaurus, Web Search).
  • Behavioral: Tier-Palliative Care
    Summary: Multi-level palliative intervention that manages symptoms and improves quality of life for advanced cancer patients, adjusting care intensity as needs evolve throughout disease trajectory (Web Search).

Key Inclusion

  • Advanced lung or non-colorectal gastrointestinal cancer or triple negative breast cancer
  • One hospitalization within last 6 months for cancer patients
  • KPS ≥50% (ECOG 0, 1 or 2)
  • Manhattan or Queens residence
  • ≥18 years of age
  • English or Spanish fluency

Key Exclusion

  • Diagnoses of both cancer and advanced heart failure
  • Lung cancer with driver mutation (e.g., EGFR) conferring favorable prognosis
  • >1 visit to Outpatient Supportive Oncology/Cardiology
  • Last Supportive Oncology/Cardiology visit <3 months ago
  • Receiving hospice care or enrolled in another palliative care intervention study
  • Living in facility (rehab, long-term care, hospice)
  • Callahan 6-Item Cognitive Screening score ≤3

NCT07553819

Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention

Organization/Sponsor: Roswell Park Cancer Institute


Example patient: A 58-year-old current smoker with a 30-pack-year history, no prior cancer diagnosis, no recent respiratory infections, and stable cardiovascular health who is motivated to participate in exercise-based lung cancer prevention.

Phase N/A

Interventions

  • Behavioral: Respiratory Muscle Training
    Summary: Strengthens diaphragm and respiratory muscles through resistance and endurance training to improve lung function and reduce breathing difficulties. Used in lung cancer patients to minimize post-surgery fatigue and treatment side effects (NCI Thesaurus, Web Search).
  • Behavioral: Aerobic Exercise
    Summary: Sustained exercise increasing oxygen demand on cardiovascular system, enhancing cardiorespiratory fitness and potentially immune function. Clinical trials show improved survival rates and reduced cancer progression in lung cancer patients (NCI Thesaurus, Web Search).
  • Other: Survey Administration
    Summary: Presentation of questionnaires to obtain self-reported data on patient experiences, knowledge, and anxiety related to trial participation (NCI Thesaurus, Web Search).
  • Other: Supportive Care
    Summary: Helps patients cope with cancer through symptom management, psychological support, and practical advice to maximize treatment benefits and improve quality of life (NCI Thesaurus, Web Search).
  • Other: Physical Performance Testing
    Summary: Assesses exercise capacity and physical function through tests like walking speed to evaluate fitness and guide lung cancer treatment decisions (NCI Thesaurus, Web Search).
  • Other: Electronic Health Record Review
    Summary: Analysis of patient data to improve care outcomes, assess physical activity, and provide personalized feedback for enhanced patient engagement (NCI Thesaurus, Web Search).
  • Other: Educational Intervention
    Summary: Educational activities using lectures, brochures, and multimedia to prevent disease or alter disease course by improving patient knowledge and addressing lifestyle changes (NCI Thesaurus, Web Search).
  • Other: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for research to analyze genetic and molecular features, understand cancer mechanisms, and develop targeted therapies (NCI Thesaurus, Web Search).
  • Other: Accelerometry
    Summary: Quantifies physical activity levels using acceleration measurement instruments, showing inverse association with cancer risk through increased activity (NCI Thesaurus, Web Search).

Key Inclusion

  • Age ≥ 50 years old
  • Current smoker with ≥ 20-pack-years history
  • Former smoker within past 15 years with ≥ 20 pack-years
  • Able to speak, read and comprehend English
  • Cognitively capable of following direction and performing intervention
  • Signed informed consent

Key Exclusion

  • Previous lung cancer diagnosis or undergoing cancer treatment
  • Recent pneumonia, bronchitis, or inflammatory lung conditions within 6 months
  • COPD or asthma exacerbation within previous 6 months
  • Uncontrolled intercurrent illness including heart failure or psychiatric illness
  • Unwilling or unable to follow protocol requirements

NCT07153055

Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer Genomic-based

Organization/Sponsor: Indiana University


Example patient: A 62-year-old woman with EGFR exon 19 deletion-positive NSCLC who progressed on osimertinib with biopsy-confirmed transformation to small cell lung cancer, ECOG performance status 1, completed platinum/etoposide chemotherapy 4 weeks ago, and has measurable disease without brain metastases.

Phase 1, Phase 2

Interventions

  • Drug: Osimertinib
    Summary: A third-generation, irreversible, mutant-selective EGFR tyrosine kinase inhibitor that covalently binds to and inhibits mutant EGFR forms including T790M, L858R, and exon 19 deletions, preventing EGFR-mediated signaling and inducing cell death in EGFR-overexpressing tumors (NCI Thesaurus, FDA label).
  • Drug: Lurbinectedin
    Summary: An alkylating drug that covalently binds to DNA minor groove residues, inhibiting transcription and causing delayed S phase progression, G2/M cell cycle arrest, and cell death; FDA-approved for metastatic small cell lung cancer after platinum-based chemotherapy (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed transformation to small cell lung carcinoma
  • Initial diagnosis of EGFR-mutated non-small cell lung cancer
  • Received EGFR targeted therapy osimertinib
  • No acquired MET amplification >6 copies or EGFR C797S resistance
  • Measurable disease per RECIST version 1.1
  • ECOG performance status ≤2
  • Adequate hematologic, hepatic, and renal function
  • Prior platinum/etoposide after transformation permitted if ≥3 weeks since last cycle

Key Exclusion

  • EGFR exon 20 insertion alterations, C797S, or MET amplification resistance
  • Pregnant or breastfeeding
  • Symptomatic or unstable brain metastases requiring >2 mg dexamethasone daily
  • Known history of interstitial lung disease or pneumonitis >grade 1
  • Prior Stevens-Johnson Syndrome, toxic epidermal necrolysis, or aplastic anemia on osimertinib
  • Mean resting QTc >500 msec or congenital long QTc syndrome
  • Unstable cardiac conditions or symptomatic CHF (NYHA class III or IV)
  • Documented severe allergic or anaphylactic reaction to osimertinib or lurbinectedin ingredients

NCT07365319

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008). Genomic-based

Organization/Sponsor: Eikon Therapeutics


Example patient: A 62-year-old patient with newly diagnosed Stage 4 non-squamous NSCLC without EGFR, ALK, or other actionable mutations, ECOG performance status 1, with measurable lung and liver metastases, and no prior systemic therapy for metastatic disease.

Phase 2, Phase 3

Interventions

  • Drug: Pemetrexed + Cisplatin/Carboplatin
    Summary: Chemotherapy regimen combining pemetrexed with cisplatin or carboplatin, used for treating non-small cell lung cancer and mesothelioma (NCI Thesaurus).
  • Drug: Nab-paclitaxel + Carboplatin
    Summary: Combination of albumin-bound paclitaxel with carboplatin, a platinum compound that disrupts cancer cell DNA, used for NSCLC and other cancers (FDA label, NCI Thesaurus).
  • Drug: Paclitaxel + Carboplatin
    Summary: Platinum-based chemotherapy combining paclitaxel with carboplatin, which disrupts cancer cell DNA for treating advanced carcinomas (FDA label).
  • Other: Placebo
    Summary: Inactive compound identical in appearance to study treatment, used to distinguish drug action from suggestive effects in experimental research (NCI Thesaurus).
  • Biological: Pembrolizumab (KEYTRUDA)
    Summary: PD-1 immune checkpoint inhibitor that enhances T-cell response against lung cancer cells, showing significant survival benefits in advanced NSCLC (Summary of Web Search).
  • Drug: EIK1001
    Summary: TLR7/8 agonist that activates antigen-presenting cells and dendritic cells, stimulating cytotoxic T-lymphocyte and B-lymphocyte immune responses leading to tumor lysis (NCI Thesaurus).

Key Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed Stage 4 NSCLC (squamous or non-squamous)
  • No tumor-activating mutations requiring targeted therapy (EGFR, ALK, RET, ROS1, BRAF)
  • At least 1 measurable lesion per RECIST 1.1
  • No prior systemic therapy for advanced/metastatic NSCLC
  • ECOG Performance Status 0 to 1
  • Tumor tissue available for PD-L1 testing from non-irradiated site
  • Life expectancy at least 3 months

Key Exclusion

  • Small cell elements present histologically
  • Participated in investigational study within 4 weeks or 5 half-lives
  • Major surgery within 3 weeks prior to first dose
  • Live-virus vaccination within 30 days of study start
  • Radiation therapy within 7 days of first dose
  • Palliative radiotherapy within 7 days of first dose

NCT07513376

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014) Genomic-based

Organization/Sponsor: Merck Sharp & Dohme LLC


Example patient: A 62-year-old former smoker with completely resected Stage I lung adenocarcinoma (3.5 cm tumor with lymphovascular invasion), no prior cancer treatments, controlled hypertension, and available tumor tissue for genomic sequencing.

Phase 3

Interventions

  • Biological: Placebo
    Summary: An inactive compound identical in appearance to the active treatment, used to distinguish drug action from suggestive effects in controlled trials (NCI Thesaurus).
  • Biological: Pembrolizumab coformulated with berahyaluronidase alfa
    Summary: A fixed-dose combination of pembrolizumab (anti-PD-1 antibody) and berahyaluronidase alfa (hyaluronidase) for subcutaneous delivery; blocks PD-1 pathway to enhance immune response against cancer cells (FDA label, NCI Thesaurus).
  • Biological: Intismeran
    Summary: An mRNA-based personalized cancer vaccine targeting twenty patient-specific tumor neoantigens; induces cytotoxic T-cell and memory T-cell responses against cancer cells expressing these epitopes (NCI Thesaurus).

Key Inclusion

  • Pathological Stage I NSCLC (tumor ≤4 cm) per AJCC 9th Edition
  • At least one high-risk feature: tumor >2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology
  • Complete surgical resection of primary NSCLC
  • No prior treatment outside of definitive surgery
  • Tissue sample from recent surgery and blood sample provided
  • HIV-infected participants with well-controlled HIV on ART eligible
  • HBsAg positive participants eligible if on HBV antiviral therapy ≥4 weeks with undetectable viral load
  • HCV history eligible if viral load undetectable at screening

Key Exclusion

  • Small cell lung cancer, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs
  • Clinically significant cardiovascular disease within 12 months (CABG, PCI, NYHA Class III-IV heart failure, MI, CVA)
  • HIV-infected with history of Kaposi's sarcoma or Multicentric Castleman's Disease
  • Additional malignancy progressing or requiring active treatment within past 3 years
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History of pneumonitis/interstitial lung disease requiring steroids or current pneumonitis
  • Active infection requiring systemic therapy (except permitted infections)
  • History of stem cell or solid organ transplant

NCT07594522

Phase II Study of Ivonescimab Consolidation After Photon or Proton SBRT for Patients With Early-Stage NSCLC (I-PRECISE) Genomic-based

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 68-year-old male with ECOG 1, Stage IIA NSCLC (3.5cm tumor, N0M0) without EGFR or ALK mutations, medically inoperable due to cardiac comorbidities, suitable for 5-fraction SBRT with tumor not contacting esophagus.

Phase II

Interventions

  • Biologic: Ivonescimab
    Summary: A bispecific antibody targeting PD-1 and VEGF that inhibits immune checkpoints and tumor angiogenesis, activating T-cells and blocking vascular endothelial growth to reduce tumor proliferation and metastasis (NCI Thesaurus, Web Search).
  • Radiation: Photon or Proton standard stereotactic body radiotherapy (SBRT)
    Summary: Stereotactic radiation therapy delivering one or several maximum dose treatments targeting body cancers excluding brain or spine (NCI Thesaurus).

Key Inclusion

  • Pathologically confirmed non-small cell lung cancer
  • Early Stage NSCLC Stage IA2-IIA (tumor >1cm and ≤5cm, N0M0) or select IIB (tumor >5cm and ≤7cm, N0M0)
  • No known sensitizing EGFR or ALK alterations
  • Unwilling or ineligible for surgical resection
  • Disease amenable to 3, 5 or 8 fraction SBRT
  • Age ≥18 years
  • ECOG Performance Status ≤1
  • Adequate hematologic, renal, hepatic, and cardiac function

Key Exclusion

  • Primary tumor contacts the esophagus
  • Prior receipt of immune checkpoint inhibitors
  • Prior thoracic radiation precluding definitive SBRT
  • Active or prior documented autoimmune or inflammatory disorders
  • History of idiopathic pulmonary fibrosis or interstitial lung disease
  • Active hepatitis B or C, HIV, tuberculosis, or chronic infections
  • History of arterial thromboembolic event or Grade 3+ venous thromboembolic event within 12 months
  • Poorly controlled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg)

NCT06943664

Phase II Trial: Photoimmunotherapy and Anti-PD1 in Patients With Refractory Inoperable and Metastatic Non-Small Cell Lung Cancer Genomic-based

Organization/Sponsor: Roswell Park Cancer Institute


Example patient: A 62-year-old male with stage IV NSCLC harboring EGFR mutation who progressed after osimertinib, platinum-doublet chemotherapy, and pembrolizumab, with ECOG performance status 1, two measurable lung lesions including one accessible superficial chest wall mass, and adequate organ function.

Phase II

Interventions

  • Diagnostic Test: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and magnetic fields to provide detailed pictures of internal organs and tissues, valuable for diagnosing cancer and monitoring treatment response (NCI Thesaurus).
  • Procedure: Video-Assisted Thoracic Surgery
    Summary: Minimally invasive thoracic surgery aided by video camera, showing improved survival rates in early-stage NSCLC with 21% reduced mortality compared to open surgery (Summary of Web Search, NCI Thesaurus).
  • Procedure: Robotic Bronchoscopy
    Summary: Robotic-assisted bronchoscopy providing precise control and access to hard-to-reach lung areas, enhancing accuracy in biopsies and tissue sampling for lung cancer diagnosis (NCI Thesaurus, Summary of Web Search).
  • Diagnostic Test: Positron Emission Tomography
    Summary: Imaging technique measuring gamma radiation from positron-electron collisions using radioactive tracers like FDG to detect metabolic activity, evaluate treatment response, and identify metastatic spread (NCI Thesaurus).
  • Procedure: Photoimmunotherapy
    Summary: Cancer treatment combining photodynamic and immunotherapy using photosensitizer and laser to produce reactive oxygen that kills cancer cells and enhances immune responses against tumors (NCI Thesaurus, Summary of Web Search).
  • Procedure: Endobronchial Ultrasound Bronchoscopy
    Summary: Minimally invasive procedure using endoscopic ultrasound for visualizing and sampling lymph nodes, improving lung cancer staging accuracy and reducing time to treatment via EBUS-TBNA (NCI Thesaurus, Summary of Web Search).
  • Other: Electronic Health Record Review
    Summary: Checking and assessing data in electronic health records to improve patient care through personalized feedback and support (NCI Thesaurus, Summary of Web Search).
  • Diagnostic Test: Computed Tomography
    Summary: Imaging method using X-rays and computer reconstruction to create cross-sectional scans, providing detailed images to monitor tumor progression and assess treatment effectiveness (NCI Thesaurus).
  • Drug: Cetuximab Sarotalocan Sodium
    Summary: Antibody-drug conjugate linking IR700 dye to cetuximab (anti-EGFR monoclonal antibody); upon near-infrared light activation, selectively kills EGFR-expressing tumor cells via membrane disruption for targeted phototherapy (NCI Thesaurus, FDA label).
  • Drug: Cemiplimab
    Summary: PD-1 blocking monoclonal antibody that inhibits PD-1/PD-L1 interaction to restore immune function and activate cytotoxic T-cells; FDA-approved for NSCLC as monotherapy or with platinum-based chemotherapy (FDA label, NCI Thesaurus).
  • Other: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for testing, diagnostic, and research purposes to analyze genetic and molecular features for understanding cancer mechanisms and developing targeted therapies (NCI Thesaurus, Summary of Web Search).

Key Inclusion

  • Stage IIIB-IV NSCLC histologically or cytologically confirmed
  • Previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy
  • NSCLC with actionable genomic alterations (EGFR, ALK, ROS1, BRAF) must have received all approved targeted therapies
  • At least two lesions of measurable disease by RECIST 1.1
  • At least one site accessible to photoimmunotherapy (690-nm laser light)
  • ECOG performance status 0-2
  • Adequate organ function (ANC ≥1000/µL, platelets ≥100,000/µL, CrCl ≥50 mL/min)
  • Age ≥18 years

Key Exclusion

  • Investigational agent within 30 days or major surgery within 4 weeks
  • Chemotherapy or chemoimmunotherapy within 21 days
  • History of immune-related adverse events leading to permanent treatment discontinuation
  • Active autoimmune disorder requiring systemic steroids or immunosuppressants
  • Untreated or symptomatic brain metastases or leptomeningeal disease
  • Clinically significant cardiovascular disease within 6 months
  • Active hepatitis B, hepatitis C, or HIV infection
  • History of grade ≥3 cetuximab infusion reactions

NCT07488676

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types Genomic-based

Organization/Sponsor: Astellas Pharma Inc


Example patient: A 58-year-old woman with CLDN18.2-positive metastatic pancreatic adenocarcinoma, ECOG 1, who progressed after one line of gemcitabine-based chemotherapy, with stable treated brain metastases off steroids for 4 weeks, and adequate organ function.

Phase 1, Phase 2

Interventions

  • Drug: ASP546C
    Summary: ASP546C is an antibody-drug conjugate targeting CLDN18.2-positive solid tumors. It delivers cytotoxic agents directly to cancer cells expressing CLDN18.2. Currently in Phase 3 trials for various malignancies including breast cancer. Source: Web Search Summary.

Key Inclusion

  • Histologically confirmed gastroesophageal, pancreatic adenocarcinoma, or pan-tumor (cholangiocarcinoma, colorectal, NSCLC, SCLC, ovarian, breast cancer)
  • Tumor expresses CLDN18.2
  • Radiologically confirmed unresectable locally advanced or metastatic disease
  • Received at least 1 prior line of therapy for advanced/metastatic disease
  • ECOG performance status 0 or 1
  • Life expectancy ≥12 weeks
  • Measurable disease per RECIST v1.1 (Cohorts 1-3) or evaluable disease (Cohort 4)
  • Adequate laboratory parameters within 14 days of first dose

Key Exclusion

  • Non-adenocarcinoma or mixed histology (Cohorts 1-3)
  • >2 prior lines of therapy for advanced disease (Cohorts 1-3)
  • Symptomatic or untreated brain metastases
  • Active autoimmune disease requiring high-dose steroids
  • Significant cardiovascular disease or QTc >470 msec
  • Prior CLDN18.2 ADC treatment
  • Active infection requiring systemic therapy within 7 days
  • HER2 positive status (Cohorts 1-2 gastroesophageal only)

NCT07619339

A Pilot Study of Tepotinib + Ivonescimab in Patients With Advanced METex14 Skipping Positive NSCLC Genomic-based

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 62-year-old with stage IV lung adenocarcinoma harboring MET exon 14 skipping mutation confirmed by FDA-approved testing, ECOG status 1, who progressed on platinum-based chemotherapy without prior bevacizumab exposure and no other actionable mutations.

Phase N/A

Interventions

  • Drug: Ivonescimab
    Summary: A bispecific antibody targeting PD-1 and VEGF that inhibits immune checkpoints and angiogenesis, studied for lung cancer treatment. It blocks PD-1/PD-L1 interaction to activate T-cells and inhibits VEGF/VEGFR signaling to reduce tumor vascularization. Source: NCI Thesaurus, Web Search.
  • Drug: Tepotinib
    Summary: An oral MET tyrosine kinase inhibitor approved by FDA for metastatic NSCLC with MET exon 14 skipping alterations. It disrupts MET signaling pathways to induce apoptosis in tumor cells overexpressing this kinase. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Pathologically confirmed non-small cell lung cancer
  • MET exon 14 skipping documented by FDA-approved assay in CLIA-certified laboratory
  • Advanced or recurrent disease (stage IV or stage IIIB/C not amenable to local therapy)
  • Measurable disease by RECIST 1.1 criteria
  • Age 18 or older
  • ECOG Performance Status 0-2
  • Adequate organ function (ANC ≥1500, platelets ≥100000, hemoglobin ≥9 g/dL)
  • Creatinine clearance ≥50 mL/min

Key Exclusion

  • Other actionable oncogenic alterations (EGFR, ALK, ROS1, RET, NTRK, HER2, KRAS, BRAF V600E)
  • Untreated or symptomatic brain metastases or leptomeningeal disease
  • Prior angiogenesis inhibitor therapy (bevacizumab or ramucirumab)
  • Prior Grade 3 or higher immune-related adverse events
  • Active autoimmune disease requiring systemic therapy within 2 years
  • Major blood vessel invasion or risk of fistula formation
  • Cardiovascular events (MI, unstable angina, CHF) within 6 months
  • Active hepatitis C infection

NCT07578571

A Phase 1 Study of IM-1617 in Participants With Advanced Malignancies Genomic-based

Organization/Sponsor: Immunome, Inc.


Example patient: A 62-year-old male with metastatic RAS wild-type colorectal adenocarcinoma, ECOG 1, who has progressed on FOLFOX, FOLFIRI, bevacizumab, and cetuximab with measurable liver metastases and no CNS involvement.

Phase 1

Interventions

  • Drug: IM-1617
    Summary: IM-1617 is an antibody-drug conjugate with a topoisomerase-1 inhibitor payload targeting undisclosed receptors in advanced solid tumors including CRC, NSCLC, and breast cancer. Source: Web Search Summary.

Key Inclusion

  • ECOG performance status 0, 1, or 2
  • Histological diagnosis of unresectable locally advanced or metastatic solid tumors including CRC, NSCLC, breast cancer, esophageal/gastric adenocarcinoma
  • Part B CRC: progressed on fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-EGFR therapy if RAS wild-type
  • Part B NSCLC: progressed on platinum-based chemotherapy and PD-1/PD-L1 monoclonal antibody
  • Participants with actionable biomarkers must have received prior appropriate targeted therapy
  • Measurable disease per RECIST v1.1
  • Disease considered noncurative with no satisfactory standard of care options
  • Part A: progressed on or intolerant to prior standard of care treatments

Key Exclusion

  • Previously treated with ADC with TOP1 inhibitor payload, except up to one prior for NSCLC or breast cancer
  • History of anaphylactic reaction to TOP1 inhibitors or TOP1 inhibiting ADCs
  • Life expectancy less than 12 weeks
  • Prior solid organ transplant
  • Symptomatic ascites or pleural effusion
  • Known active CNS metastases or carcinomatous meningitis
  • History of another primary malignancy unless no recurrence for at least 2 years

NCT07476287

A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER Genomic-based

Organization/Sponsor: Pfizer


Example patient: A 62-year-old male with ECOG status 1, previously diagnosed with EGFR-mutated NSCLC that transformed to SCLC after osimertinib treatment, now presenting with measurable lung lesions and no prior chemotherapy for T-SCLC.

Phase 2

Interventions

  • Drug: PF-08634404
    Summary: PF-08634404 is a targeted therapy that acts on specific cancer-related pathways, currently in clinical trials for BRAF-mutated colorectal cancer and being evaluated in transformed SCLC (Source: Web Search).
  • Drug: Chemotherapy
    Summary: Chemotherapy uses synthetic or naturally-occurring drugs that target rapidly dividing cancer cells by causing DNA damage and inhibiting cell proliferation (Source: NCI Thesaurus, Web Search).

Key Inclusion

  • Age ≥18 years
  • Histologically or cytologically confirmed T-SCLC transformed from EGFR-mutated NSCLC after TKI treatment
  • No prior systemic therapy for T-SCLC
  • At least one measurable lesion per RECIST v1.1
  • Sufficient tumor tissue from transformed SCLC diagnosis available
  • ECOG performance status 0 or 1
  • Life expectancy >12 weeks
  • Acceptable clinical laboratory values at screening

Key Exclusion

  • Active or untreated CNS disease or leptomeningeal disease
  • Clinically significant hemorrhage risk or fistula risk
  • History of another malignancy within 3 years
  • Unresolved toxicity >Grade 1 from prior therapy
  • Active autoimmune disease requiring systemic treatment within 2 years
  • Interstitial lung disease, pneumonitis, or DLCO <50% predicted
  • Uncontrolled cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months
  • Active uncontrolled infection including TB, hepatitis B/C, or uncontrolled HIV

NCT07488923

A Phase 1 First-In-Human Study to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of ML261, an Autologous Anti-DLL3 CAR + CARD11-PIK3R3 Fusion T Cell Therapy, in Participants With Relapsed/Refractory Small Cell Lung Cancer or Select Neuroendocrine Carcinomas Genomic-based

Organization/Sponsor: Moonlight Bio, Inc


Example patient: A 62-year-old patient with metastatic relapsed small cell lung cancer after two lines of chemotherapy, ECOG PS 1, with DLL3-positive tumor confirmed by biopsy, no brain metastases, and adequate organ function.

Phase 1

Interventions

  • Biological: ML261
    Summary: ML261 is an autologous CAR T cell therapy targeting DLL3 with CARD11-PIK3R3 fusion for enhanced T cell function. It involves genetically modifying patient T cells to recognize and attack DLL3-expressing cancer cells in small cell lung cancer and neuroendocrine carcinomas. Source: Web Search and trial title.

Key Inclusion

  • ≥18 years of age
  • At least one prior line of systemic standard of care anti-cancer therapy
  • Documented radiological disease progression/relapse with measurable disease per RECIST v1.1
  • Histologically/cytologically confirmed advanced or metastatic R/R SCLC, GEP-NEC, high-grade NEPC, or epNEC
  • Biopsy-documented DLL3 expression on archival tissue or fresh biopsy
  • ECOG Performance Score 0 or 1
  • Life expectancy ≥12 weeks
  • Adequate hematologic and end-organ function

Key Exclusion

  • Prior DLL3-targeted CAR T therapy or genetically engineered adoptive T cell therapy
  • Prior allogeneic organ or bone marrow transplant
  • Major surgery within 4 weeks or anticipated during study
  • Symptomatic ascites or effusions requiring intermittent drainage
  • Myocardial infarction within 6 months or NYHA Class III-IV heart failure
  • Known brain metastases unless asymptomatic and steroid-free for ≥2 weeks
  • Active systemic autoimmune disease requiring systemic steroids or immunosuppressive agents
  • Active infection requiring systemic therapy within 14 days of leukapheresis

NCT07443020

Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors: A Phase I Trial (FAST TILS 2)

Organization/Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)


Example patient: A 62-year-old male with biopsy-proven mesothelioma and recurrent pleural effusions, ECOG status 1, who has progressed on standard chemotherapy with no cardiac disease or active infections.

Phase 1

Interventions

  • Biological: Interleukin-2 (IL-2)
    Summary: Aldesleukin is a recombinant interleukin-2 lymphocyte growth factor that enhances lymphocyte activation and proliferation for treating metastatic cancers. It is administered intravenously and requires intensive monitoring due to risks of capillary leak syndrome, hypotension, and multi-organ toxicity (FDA label).
  • Biological: locally manufactured adoptive cellular therapy (ACT) product
    Summary: Fast TIL involves infusing expanded tumor-infiltrating lymphocytes back into the patient to enhance immune response against cancer cells. The mechanism enhances the body's own immune cells to specifically attack cancer (Web Search).

Key Inclusion

  • Symptomatic, biopsy-proven malignant to pleura or mesothelioma with pleural effusions
  • Refractory to or failed available standard of care therapy
  • Age ≥18 and <80 years
  • Cardiac ejection fraction ≥0.45
  • ECOG Performance Status 0 or 1
  • Expected survival >12 weeks
  • No requirement for supplemental oxygen and no dyspnea after effusion drainage

Key Exclusion

  • Active HIV, hepatitis B, or hepatitis C with viral replication
  • Current bacterial, fungal, or viral infection treatment
  • Myocardial infarction within 6 months or symptomatic cardiac disease
  • Cytotoxic anti-cancer or radiation therapy within 2 weeks
  • Corticosteroid therapy >10 mg prednisone equivalent within 2 weeks
  • Significant laboratory abnormalities (AST/ALT >2x ULN, bilirubin >2x ULN, creatinine >2x ULN)
  • Pregnant or lactating females
  • Prior solid organ transplantation

NCT07278479

A Phase 1/2a Study to Assess Safety, Tolerability, and Efficacy of [212Pb]Pb-DOTAM-MAM279 in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors Genomic-based

Organization/Sponsor: Molecular Partners AG


Example patient: A 62-year-old patient with extensive-stage small cell lung cancer and DLL3-positive disease by SPECT/CT, progressing after two lines of platinum-based chemotherapy and immunotherapy, with stable brain metastases and adequate organ function.

Phase 1, Phase 2

Interventions

  • Radioligand Therapy: [203Pb]Pb-MP0712
    Summary: Diagnostic radioligand targeting DLL3-expressing cancer cells, delivering lead-203 radiation for imaging via SPECT/CT to identify DLL3-positive tumors in lung cancer and neuroendocrine carcinomas (Source: Web Search).
  • Radioligand Therapy: [212Pb]Pb-MP0712
    Summary: Therapeutic radioligand targeting DLL3 receptors on cancer cells, delivering alpha-particle radiation via lead-212 to induce tumor cell death in lung cancer and other solid tumors (Source: Web Search).

Key Inclusion

  • Age ≥18 years
  • Advanced extensive or limited SCLC or large cell neuroendocrine carcinomas of lung
  • SCLC progression after at least two prior platinum-based therapy and immunotherapy lines
  • LC NEC or extrapulmonary NEC progression after at least one prior systemic therapy
  • DLL3-positivity by [203Pb]Pb-DOTAM-MAM279 SPECT/CT for epNECs and Part 2 SCLC/LC NEC
  • At least one measurable disease per RECIST v1.1
  • Adequate bone marrow, hepatic, and renal function
  • Calculated GFR >60 mL/min

Key Exclusion

  • Uncontrolled intercurrent illness
  • Unresolved toxic effects from prior therapy >Grade 1 except alopecia or stable neuropathy
  • Active clinically significant cardiac disease
  • Evidence of interstitial lung disease or active non-infectious pneumonitis
  • History of other malignancy within past 2 years with exceptions

NCT07636200

The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer

Organization/Sponsor: University of Colorado, Boulder


Example patient: A 62-year-old English-speaking patient with extensive stage small cell lung cancer, ECOG status 1, experiencing significant fear of disease progression and cancer-related distress without history of psychiatric hospitalization or cognitive impairment.

Phase N/A

Interventions

  • Behavioral: Usual Care Control Condition
    Summary: Standard treatment protocols without experimental interventions, serving as a benchmark to measure effectiveness of new treatments in lung cancer trials (Summary of Web Search).
  • Behavioral: Written Exposure-Based Coping Intervention (EASE)
    Summary: Structured writing intervention targeting fear of cancer progression and trauma symptoms to reduce psychological distress in metastatic cancer patients including lung cancer (Summary of Web Search).

Key Inclusion

  • Adults age 18 or older
  • Stage IV metastatic cancer of any solid tumor type or extensive stage small cell lung cancer
  • Stage III recurrent ovarian cancer or glioblastomas of any staging
  • ECOG Performance Status ≤2
  • Elevated fear of progression: FoP-Q mean score ≥2.5 or total ≥30
  • Elevated trauma symptoms: IES-R mean ≥1.5 or total ≥33
  • Fluent in English or Spanish, can read English proficiently
  • Capable of understanding consent, attending sessions, and writing for 30 minutes

Key Exclusion

  • History of chronic untreated trauma unrelated to cancer
  • Psychiatric hospitalization in past 2 years
  • Suicide attempt in past 2 years
  • Current high suicide risk
  • EMR-noted cognitive impairment such as dementia