Lung Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in August 2026

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

Overview

Number of Trials: 18

The 18 trials predominantly focus on lung cancer (NSCLC and SCLC) treatment strategies including targeted therapies, immunotherapies, ADCs, CAR T-cells, and chemotherapy combinations. Additional trials address anticoagulation, radiotherapy optimization, lung cancer screening, and cardioprotection. Several trials leverage biomarker-driven eligibility such as EGFR, ALK, KRAS G12D/G12V, and DLL3 expression.

Common Criteria Across Trials

Common Inclusion

Age ≥18 years
Histologically or cytologically confirmed cancer diagnosis
ECOG performance status 0-1 (or up to 2/3 in some trials)
Measurable disease per RECIST v1.1
Adequate organ and hematologic function
Signed informed consent
Negative pregnancy test/contraception requirements for reproductive-age participants

Common Exclusion

Untreated or symptomatic CNS metastases
Prior therapy with similar investigational agents or drug classes
Active autoimmune disease requiring systemic immunosuppression
Uncontrolled cardiac disease or recent cardiovascular events
Active or chronic uncontrolled infections (HIV, HBV, HCV)
Pregnancy or breastfeeding
Other malignancy within past 2-5 years (with exceptions)

Outcomes Summary

Primary Outcomes

Safety and tolerability (adverse events, dose-limiting toxicities) (10 trials)
Overall response rate / objective response rate (6 trials)
Progression-free survival (5 trials)
Overall survival (3 trials)
Feasibility of intervention/procedure (3 trials)
Incidence of venous thromboembolism/bleeding events (2 trials)

Secondary Outcomes

Duration of response (5 trials)
Pharmacokinetics (5 trials)
Quality of life measures (3 trials)
Disease control rate (2 trials)
Patient-reported adherence/engagement (2 trials)

2: Extracted Trials with New Information

Trials with Special Criteria

Genomic / Biomarker Trials

NCT07784959 — Requires ALK-positive NSCLC; excludes resistance mutations or other actionable driver alterations.
NCT06449313 — Requires EGFR and ALK wild-type status via CLIA-certified testing.
NCT07153055 — Requires EGFR-mutated NSCLC with transformation to SCLC; excludes MET amplification or EGFR C797S resistance.
NCT07594067 — Requires HLA-A*11:01 positivity and KRAS G12V mutation confirmed by NGS.
NCT07718737 — Requires known EGFR status; excludes EGFR-activating mutations.
NCT07783477 — Requires DLL3+ tumor status confirmed by IHC.
NCT07777822 — Requires documented RAS G12D mutation and known PD-L1 status.

Unique or Unusual Criteria

NCT07675876 — Repurposes an asthma mast cell stabilizer for oncologic use via inhalation route.
NCT07685938 — Uses statin and ACE-inhibitor combination for cardioprotection during radiotherapy, not cancer treatment itself.
NCT07599943 — Behavioral health intervention using text messages, chatbots, and patient navigation to boost screening rates, not a drug trial.
NCT07679607 — Focuses on radiotherapy planning technique (INSPIRE RT) to spare lung function rather than a drug intervention.
NCT07630168 — Tests circadian timing of immunotherapy infusion (morning vs afternoon) as the primary variable.

Trials with Emerging Treatments

NCT07675876 — Inhaled Cromolyn Sodium in Locally Advanced Lung Cancer
Items: Cromolyn Sodium
Note: Repurposing existing ANDA drug via novel inhaled route for oncologic indication.
NCT07784959 — NXP900 Plus Lorlatinib in ALK-positive NSCLC
Items: NXP900
Note: Novel SRC/YES1 kinase inhibitor with no FDA approval; combined with approved TKI to overcome resistance.
NCT07625644 — BL-M14D1 and Atezolizumab vs SOC in Extensive-Stage SCLC
Items: BL-M14D1
Note: Novel DLL3-targeted ADC without prior FDA approval combined with checkpoint inhibitor.
NCT07493304 — REGN7508 for VTE Treatment in Cancer Patients
Items: REGN7508 (cenvacibart)
Note: Novel Factor XI monoclonal antibody with no FDA approval, targeting anticoagulation without increased bleeding risk.
NCT07680764 — Imzokitug + Pumitamig + PDCT in NSCLC
Items: Imzokitug, Pumitamig
Note: Novel CCR8-targeting antibody and PD-L1/VEGF-A bispecific, both unapproved, tested in combination.
NCT07545954 — DSP-0390 Plus Atezolizumab as Maintenance in ES-SCLC
Items: DSP-0390
Note: Investigational agent with undisclosed mechanism, no FDA approval, tested as maintenance therapy.
NCT07594067 — TCR1188-ABC Cells for KRAS G12V+ Tumors
Items: TCR1188-ABC cells
Note: Novel autologous engineered TCR T-cell therapy targeting mutant KRAS and ILT4, unapproved.
NCT07718737 — AMT-116 in EGFR-Wildtype NSCLC
Items: AMT-116
Note: Novel CD44v9-directed ADC with topoisomerase-1 inhibitor payload, unapproved.
NCT07783477 — ARMADA: DLL3-SAVVYZ-IL18 CAR T Cells
Items: DLL3-SAVVYZ-IL18 CAR T cell
Note: Novel armored CAR T-cell therapy incorporating IL-18 for enhanced antitumor activity, unapproved.
NCT07777822 — Zoldonrasib in RAS G12D-Mutated NSCLC (RASolve 308)
Items: Zoldonrasib (RMC-9805)
Note: Novel covalent tri-complex KRAS G12D inhibitor, unapproved, added to standard chemo-immunotherapy backbone.

3: Individual Trial Overviews

NCT07675876

An Open-Label Pilot Study Evaluating the Safety, Feasibility, and Preliminary Clinical Activity of Inhaled Cromolyn Sodium in Participants With Locally Advanced Lung Cancer

Organization/Sponsor: Carcinex Inc

Example patient: A 62-year-old man with biopsy-confirmed stage 3 lung adenocarcinoma, stable cardiac function, no pericardial effusion, and no known cromolyn allergy, willing to give informed consent.

Phase N/A

Interventions

Drug: Cromolyn Sodium
Summary: Mast cell stabilizer that prevents release of inflammatory mediators; being tested via inhalation for safety and preliminary activity in locally advanced lung cancer. Source: Summary of Web Search.

Key Inclusion

Written informed consent
Age ≥ 18 years
Histological or cytological confirmed lung cancer diagnosis
Locally advanced stage 3 lung cancer or adenocarcinoma
Previous tumor scan location in lung

Key Exclusion

Investigational drug/device within 4-6 weeks or 5 half-lives before screening
Known pericardial effusion
Active infection or serious systemic disorder (e.g., heart failure)
Concurrent participation in another experimental trial
Medical condition making patient unsuitable per Investigator
Known allergy or serious adverse event with Cromolyn Sodium

NCT07784959

A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer Genomic-based

Organization/Sponsor: Nuvectis Pharma, Inc.

Example patient: A 62-year-old with metastatic ALK-positive NSCLC previously treated with lorlatinib and one line of chemotherapy, tolerating lorlatinib well, without known resistance mutations or other targetable driver alterations.

Phase 1b

Interventions

Drug: Lorlatinib
Summary: Third-generation ALK/ROS1 tyrosine kinase inhibitor that blocks ALK-driven signaling in NSCLC, effective against many resistance mutations and crosses the blood-brain barrier. Source: FDA label, NCI Thesaurus, Web Search.
Drug: NXP900
Summary: Oral SRC/YES1 family kinase inhibitor that locks these kinases in an inactive conformation, blocking oncogenic signaling and tumor cell proliferation; combined with lorlatinib to overcome resistance in ALK-positive NSCLC. Source: NCI Thesaurus, Web Search.

Key Inclusion

Age 18 or older
Unresectable, metastatic or locally advanced ALK-positive NSCLC
Received lorlatinib as first or second line TKI
One prior line of systemic chemotherapy permitted
Tolerated lorlatinib at the dose level being explored or higher

Key Exclusion

Known ALK mutations causing lorlatinib resistance
Other actionable oncogenic drivers with approved targeted therapies (e.g., MET, EGFR, HER2)
Contraindications to lorlatinib per USPI

NCT07625644

A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer

Organization/Sponsor: SystImmune Inc.

Example patient: A 65-year-old man newly diagnosed with extensive-stage small cell lung cancer, ECOG PS 1, with measurable liver lesions, normal organ function, no autoimmune disease or cardiac history, eligible for first-line platinum-based chemoimmunotherapy.

Phase 3

Interventions

Biologic/ADC + Immunotherapy: BL-M14D1 and Atezolizumab
Summary: BL-M14D1 is a DLL3-targeted antibody-drug conjugate delivering cytotoxic payload to SCLC cells; atezolizumab blocks PD-L1 to enhance T-cell anti-tumor activity. Combination tested as first-line treatment for extensive-stage SCLC (Source: FDA label, NCI Thesaurus, Web Search Summary).
Chemotherapy + Immunotherapy + Maintenance: Carboplatin + Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
Summary: Standard-of-care regimen combining platinum chemotherapy (carboplatin, etoposide) with PD-L1 inhibitor atezolizumab, followed by maintenance atezolizumab plus lurbinectedin, a DNA-damaging alkylating agent, for extensive-stage SCLC (Source: FDA label, NCI Thesaurus, Web Search Summary).

Key Inclusion

Histologically/cytologically confirmed first-line extensive-stage SCLC
Eligible for platinum-based chemo plus anti-PD-L1 inhibitor
At least one measurable lesion per RECIST v1.1
ECOG PS 0-1
Adequate organ function

Key Exclusion

Prior platinum/etoposide for limited-stage SCLC within 6 months
Prior topoisomerase inhibitor-based ADC therapy
History of severe heart disease
Active autoimmune or inflammatory disease
Other prior/concurrent malignancies unless disease-free ≥3 years or curatively treated skin cancers

NCT07685938

Pharmacologic Therapies to Mitigate Radiation-Associated Heart Disease

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center

Example patient: A 62-year-old non-pregnant lung cancer patient undergoing thoracic radiation, not currently on statins or ACE-inhibitors, with normal blood pressure, consents to blood draws and study participation.

Phase N/A

Interventions

Drug: Placebo
Summary: Inactive comparator with no therapeutic effect, used to assess efficacy of atorvastatin/lisinopril against radiation-associated heart disease. Source: NCI Thesaurus.
Drug Combination: Atorvastatin and Lisinopril
Summary: Atorvastatin inhibits HMG-CoA reductase to lower cholesterol; lisinopril is an ACE inhibitor lowering blood pressure. Combination studied to mitigate radiation-induced cardiac damage. Source: Summary of Web Search.

Key Inclusion

Written informed consent and HIPAA authorization
Willing and able to comply with study procedures
Consent for serial blood draws and biological specimen use
Age ≥ 18 years at consent

Key Exclusion

Pregnant or breastfeeding
Pre-existing use of a statin or ACE-inhibitor
Pre-existing hypotension

NCT07713875

Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease

Organization/Sponsor: University of Pittsburgh

Example patient: A 62-year-old man who underwent spinal surgery for metastatic lung cancer to the spine, is being discharged home, has normal renal and hepatic function, and no history of bleeding or anticoagulant use.

Phase N/A

Interventions

Drug: Apixaban
Summary: Apixaban is a direct oral Factor Xa inhibitor that prevents thrombus formation by blocking conversion of prothrombin to thrombin, used here for extended VTE prophylaxis after spinal surgery for metastatic disease. Source: FDA label, NCI Thesaurus.

Key Inclusion

Age 18 or older
Underwent spinal surgery for vertebral metastatic disease at UPMC facilities
Planned discharge to home or acute rehab, not hospice
Able to provide informed consent
Able to take oral medications
Access to telephone for follow-up

Key Exclusion

Already on therapeutic anticoagulation for another indication
History of pathological bleeding or active bleeding
Platelet count <50,000/mm3 or hemoglobin <8 g/dL
Severe renal or hepatic impairment
Pregnancy or breastfeeding
Use of strong CYP3A4/P-gp inhibitors or inducers
History of proximal GI resection affecting drug absorption
Hospital stay 30 days or greater

NCT07599943

Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers - LungSMART UH3 Clinical Trial

Organization/Sponsor: University of Utah

Example patient: A 62-year-old English-speaking former smoker attending a community health center, eligible for text-based outreach, who has never undergone lung cancer screening or discussed it with a provider.

Phase N/A

Interventions

Behavioral/Digital Health: Proactive Patient Navigation (PPN)
Summary: Staff-initiated outreach via scheduled texts and calls to encourage lung cancer screening, aiming to reduce delays and improve screening adherence. Source: Summary of Web Search.
Behavioral/Digital Health: Reactive Patient Navigation (RPN)
Summary: Support triggered by patient-initiated contact, addressing barriers to screening/treatment access through direct communication and assistance. Source: Summary of Web Search.
Educational/Digital Media: Video (VID)
Summary: Educational video intervention intended to inform patients about lung cancer screening; note: description text mismatched with DLL3/CAR-T content likely erroneous. Source: Summary of Web Search.
Digital Health Tool: Chatbot (CA)
Summary: Automated conversational agent providing reminders and information to support lung cancer screening engagement via mobile interaction. Source: Summary of Web Search.
Behavioral/Digital Health: Text Messages (TM+)
Summary: Tailored text message campaigns to promote lung cancer screening uptake and smoking cessation among at-risk patients. Source: Summary of Web Search.

Key Inclusion

Current patient at participating Community Health Centers
Speaks English or Spanish
Current or former tobacco smoker
Age 50-80
Has not opted out of text contact
Has phone capable of receiving text messages

Key Exclusion

History of lung cancer
Previous Shared Decision Making discussion about lung cancer screening
Already completed lung cancer screening (LCS)

NCT07493304

A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)

Organization/Sponsor: Regeneron Pharmaceuticals

Example patient: A 62-year-old man with metastatic lung cancer, ECOG status 1, newly diagnosed symptomatic femoral DVT confirmed by imaging, no brain metastases or bleeding disorders, and requiring anticoagulation.

Phase 3

Interventions

Drug: Apixaban
Summary: Oral direct Factor Xa inhibitor that blocks conversion of prothrombin to thrombin, preventing clot formation; used as active comparator for VTE treatment in cancer patients (FDA label, NCI Thesaurus).
Biologic: REGN7508
Summary: Human IgG4 monoclonal antibody targeting Factor XI catalytic domain, inhibiting FXI activation to prevent thrombus formation while limiting bleeding risk; investigational for cancer-associated VTE (NCI Thesaurus, Web Search summary).

Key Inclusion

ECOG performance status 0-2
Histologically confirmed malignant solid or select hematologic tumor
Newly diagnosed lower extremity DVT within 5 days of randomization (Part 1)
Newly diagnosed VTE within 5 days of randomization (Part 2)
Indication for therapeutic DOAC anticoagulation for 3-6 months

Key Exclusion

High risk of intracranial bleeding
Known bleeding disorders or hemorrhagic tumor sites
Contraindication to anticoagulation
Life expectancy less than 6 months
Acute leukemia or myelodysplastic syndrome
Primary brain tumor or brain metastases
Symptomatic or large asymptomatic pulmonary embolism (Part 1)
PE causing hemodynamic instability (Part 2)

NCT06449313

A Phase 2 Single-arm Study of Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement or Other High Risk Features Genomic-based

Organization/Sponsor: Georgetown University

Example patient: A 62-year-old man with newly diagnosed stage 3 squamous NSCLC and pathologically confirmed T3N2 disease, ECOG 0, normal organ function, no prior cancer therapy, and no autoimmune or pulmonary disease, deemed surgically resectable by his surgeon.

Phase 2

Interventions

Biologic (PD-1 inhibitor, BLA): Cemiplimab-Rwlc
Summary: Human monoclonal antibody blocking PD-1/PD-L1 interaction to restore cytotoxic T-cell anti-tumor activity; used with chemotherapy as neoadjuvant treatment for locally advanced NSCLC prior to surgical resection. Source: FDA label, NCI Thesaurus.

Key Inclusion

Stage 3 NSCLC with N3 or high-risk nodal/T-stage features (e.g., T4N2, T3invN2, bulky N2)
Deemed resectable with curative intent by treating surgeon
EGFR/ALK wild-type (except pure squamous histology)
ECOG performance status 0-1
Adequate hematologic and end-organ function
Adequate pulmonary function for planned resection
No prior systemic therapy for index lung cancer
Age ≥18 years

Key Exclusion

Small cell or large cell neuroendocrine histology
Tumor invasion of mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina
Any M1 disease
>2 involved N3 lymph node stations or contralateral hilar/supraclavicular involvement
Prior immune checkpoint inhibitor therapy
Active autoimmune disease requiring treatment incompatible with immunotherapy
History of pneumonitis or interstitial lung disease
Poorly controlled HIV, hepatitis B/C, or active infection

NCT07680764

A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Genomic-based

Organization/Sponsor: Bristol-Myers Squibb

Example patient: A 63-year-old man with newly diagnosed stage IV non-squamous NSCLC, no actionable genomic alterations, ECOG 1, measurable disease, and no prior systemic therapy or CNS metastases.

Phase 2

Interventions

Bispecific antibody: Pumitamig
Summary: Bispecific antibody targeting PD-L1 and VEGF-A; blocks immune checkpoint and neutralizes angiogenesis to enhance anti-tumor immunity. Source: Summary of Web Search.
Monoclonal antibody (CCR8 inhibitor): Imzokitug
Summary: IgG1 nonfucosylated monoclonal antibody targeting CCR8 on tumor-infiltrating regulatory T-cells, depleting Tregs via ADCC to reactivate antitumor immunity. Source: NCI Thesaurus / Summary of Web Search.
Chemotherapy - microtubule inhibitor: Paclitaxel
Summary: Microtubule inhibitor causing mitotic arrest and apoptosis; used in NSCLC combination chemotherapy. Source: FDA label.
Chemotherapy - platinum agent: Carboplatin
Summary: Platinum coordination compound inducing DNA cross-links leading to apoptosis; used in combination chemotherapy regimens. Source: FDA label/NCI Thesaurus.
Chemotherapy - platinum agent: Cisplatin
Summary: Platinum-based DNA-damaging agent causing apoptosis; part of platinum-doublet chemotherapy for NSCLC. Source: FDA label/NCI Thesaurus.
Chemotherapy - antifolate: Pemetrexed
Summary: Antifolate inhibiting thymidylate synthase, blocking DNA synthesis; used for non-squamous NSCLC. Source: FDA label/NCI Thesaurus.

Key Inclusion

Histologically confirmed stage IV or recurrent unresectable NSCLC (squamous or non-squamous)
No prior systemic anti-cancer therapy for advanced/metastatic disease
Tumor tissue (fresh or archival) submitted within 5 months of enrollment
ECOG performance status 0 or 1
Measurable disease per RECIST v1.1

Key Exclusion

Documented actionable genomic alterations with approved first-line targeted therapy
Prior treatment with immuno-oncology therapies
Untreated CNS metastases

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 exon19del NSCLC transformed to small cell carcinoma after osimertinib therapy, ECOG 1, normal organ function, and no brain metastases or cardiac disease.

Phase I, Phase II

Interventions

Drug: Osimertinib
Summary: Third-generation, irreversible EGFR tyrosine kinase inhibitor selective for EGFR mutations (exon19del, L858R, T790M), blocking EGFR signaling to induce cell death and inhibit tumor growth. Source: FDA label/NCI Thesaurus.
Drug: Lurbinectedin
Summary: Alkylating agent that binds DNA minor groove, inhibiting transcription and causing S-phase delay, G2/M arrest, and cell death; FDA-approved for metastatic SCLC post-platinum therapy. Source: FDA label/NCI Thesaurus.

Key Inclusion

≥18 years old
Histologic transformation to small cell lung cancer
Initial EGFR-mutated NSCLC treated with osimertinib
No MET amplification >6 copies or EGFR C797S resistance
Measurable disease per RECIST 1.1
ECOG performance status ≤2
Adequate hematologic, hepatic, renal function
Prior platinum/etoposide allowed but not required

Key Exclusion

EGFR exon 20 insertion or C797S resistance mutations
Pregnant or breastfeeding
Symptomatic/unstable brain metastases
History of interstitial lung disease or pneumonitis >grade 1
Prior SJS/TEN/EMM or aplastic anemia with osimertinib
Long QTc syndrome or QTc >500 msec
Unstable cardiac conditions (NYHA III/IV)
Severe allergic reaction to osimertinib or lurbinectedin excipients

NCT07545954

A Pilot Study of DSP-0390 in Combination With Atezolizumab as Maintenance Therapy for Extensive Stage Small Cell Lung Cancer

Organization/Sponsor: Washington University School of Medicine

Example patient: A 62-year-old man with extensive-stage small cell lung cancer who completed 4 cycles of chemoimmunotherapy without progression, ECOG 1, normal organ function, and no brain metastases, seeking maintenance therapy.

Pilot/Early Phase

Interventions

Biologic (BLA): Atezolizumab
Summary: Humanized monoclonal antibody blocking PD-L1, preventing PD-1/B7.1 engagement to restore T-cell mediated anti-tumor immunity; approved for multiple cancers including SCLC. Source: FDA label, NCI Thesaurus.
Investigational small molecule: DSP-0390
Summary: Investigational agent targeting undisclosed molecular pathways to inhibit cancer cell growth, being tested in combination with atezolizumab for maintenance therapy. Source: Summary of Web Search.

Key Inclusion

Histologically/cytologically confirmed small cell lung cancer
Completed 3-4 cycles of induction chemoimmunotherapy without progression
Measurable disease per RECIST 1.1
Age ≥18 years
ECOG performance status ≤2
Adequate bone marrow and organ function
Adequate contraception for childbearing potential
Signed informed consent

Key Exclusion

Untreated symptomatic brain metastases or CNS hemorrhage
Contraindication to PD-L1 inhibitors
History of allergic reaction to similar compounds
Major surgery within 28 days
Uncontrolled intercurrent illness (infection, cardiac disease)
Pregnant or breastfeeding
Short-gut syndrome or malabsorption condition
Uncontrolled HIV, HBV, or HCV infection

NCT07594067

Phase I, Open-Label Study of Autologous Mutant KRAS and ILT4-Redirected T-cell Receptor Cells (TCR1188-ABC) Genomic-based

Organization/Sponsor: University of Pennsylvania

Example patient: A 58-year-old man with metastatic KRAS G12V-positive non-small cell lung cancer, HLA-A*11:01 positive, ECOG 1, previously treated with one line of chemotherapy, with normal organ function and no active infections or brain metastases.

Phase 1

Interventions

Monoclonal Antibody: Tocilizumab
Summary: IL-6 receptor antagonist used to manage cytokine release syndrome from cell therapy; blocks IL-6 signaling to reduce inflammatory response. Source: FDA label, NCI Thesaurus.
Chemotherapy combination: Fludarabine + Cyclophosphamide combination
Summary: Lymphodepleting chemotherapy regimen given prior to T-cell infusion to reduce endogenous lymphocytes and enhance engraftment/persistence of engineered T cells. Source: Summary of Web Search.
Cell Therapy (Engineered TCR T-cells): TCR1188-ABC cells
Summary: Autologous T cells engineered with a T-cell receptor targeting mutant KRAS G12V and ILT4, designed to recognize and kill tumor cells presenting this neoantigen in HLA-A*11:01 positive patients. Source: Summary of Web Search.

Key Inclusion

Age ≥18 years
Metastatic pancreatic adenocarcinoma, cholangiocarcinoma, colorectal cancer, or NSCLC
HLA-A*11:01 positive
KRAS G12V mutation positive
Prior standard of care therapy per cancer type
Radiographically detectable disease
Adequate organ and hematologic function
ECOG performance status 0 or 1

Key Exclusion

Active hepatitis B or C infection
Severe immunodeficiency or uncontrolled HIV
Active uncontrolled infection
Class III/IV cardiovascular disease
Active second invasive cancer within 2 years
Chronic systemic steroid or immunosuppressant use
Active untreated brain metastases
Prior myocarditis or pneumonitis requiring steroids

NCT07718737

Open-Label, Global, Multicenter, Randomized, Phase 2/3 Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy Genomic-based

Organization/Sponsor: Multitude Therapeutics Inc.

Example patient: A 62-year-old woman with EGFR wild-type metastatic non-squamous NSCLC who progressed after platinum chemotherapy and pembrolizumab, with ECOG 1 and no CNS metastases, is eligible for randomization to AMT-116 or docetaxel-based therapy.

Phase 2, Phase 3

Interventions

Antibody-Drug Conjugate: AMT-116
Summary: CD44v9-directed antibody-drug conjugate with a topoisomerase-1 inhibitor payload; targets advanced NSCLC and has shown early tumor shrinkage in trials. Source: Summary of Web Search.
Chemotherapy/Combination Regimen: Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)
Summary: Docetaxel alone or with ramucirumab (a VEGFR2 inhibitor) to block angiogenesis; standard comparator regimen shown to extend survival in advanced NSCLC. Source: Summary of Web Search.

Key Inclusion

Age 18-80 with pathologically confirmed non-squamous NSCLC
Locally advanced unresectable or metastatic disease
Known EGFR wild-type status required
Progression after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy
At least one measurable lesion per RECIST 1.1
ECOG performance status 0-1
Adequate organ and marrow function
Life expectancy ≥12 weeks

Key Exclusion

EGFR-activating mutations
Prior topoisomerase-1 inhibitor ADC therapy
Untreated or unstable CNS metastases or leptomeningeal disease
Adenosquamous, neuroendocrine, or sarcomatoid histology
Active severe cardiac, pulmonary, or infectious disease
History of thromboembolic/cerebrovascular events within 6 months
Prior docetaxel treatment (Phase 3 only)
Major vessel invasion or intratumoral cavitation (Phase 3 only)

NCT07679607

GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung

Organization/Sponsor: University of Maryland, Baltimore

Example patient: A 65-year-old man with Stage III NSCLC, ECOG 1, no prior thoracic radiotherapy or metal implants, able to hold his breath 20 seconds, planned for definitive chemoradiotherapy.

Phase N/A

Interventions

Procedure: INSPIRE Radiation Treatment Planning
Summary: Experimental radiotherapy planning approach designed to spare serial and parallel lung components to preserve respiratory function; compared against standard planning. Source: Summary of Web Search.
Procedure: SOC Radiation Treatment Planning
Summary: Standard-of-care external beam radiotherapy planning using high-energy X-rays to target and kill lung cancer cells, used as comparator. Source: Summary of Web Search.

Key Inclusion

Adults ≥18 years
Histologically diagnosed Stage III NSCLC (AJCC v9)
Planned definitive external beam photon radiotherapy with/without systemic therapy
No restriction on fractions or lesion number/location
ECOG performance status ≤3
Able to hold breath ≥15 seconds
Signed informed consent
Radiation Oncologist determines benefit from INSPIRE RT (Step 2)

Key Exclusion

Prior lung cancer-directed radiotherapy
Recent (<12 mo) or planned lung surgery
Metal implants/stents in thoracic region
Severe COPD or interstitial lung disease
Pregnant or trying to conceive
No benefit from INSPIRE RT after plan comparison (Step 2)

NCT07630168

Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center

Example patient: A 62-year-old man with metastatic NSCLC, no recent steroid use, no prior immunotherapy, and not enrolled in another trial, who consents to PD-1 inhibitor infusion timing study.

Phase N/A

Interventions

Drug: PD-1 inhibitor monotherapy - 2 cycles after 3 PM
Summary: PD-1 inhibitor blocking PD-1 receptors on T-cells to enhance anti-tumor immune response; administered as 2 cycles after 3 PM to study circadian timing effects in lung cancer. Source: Summary of Web Search.
Drug: PD-1 inhibitor monotherapy - 2 cycles before 12:00PM
Summary: PD-1 inhibitor blocking the PD-1 pathway to boost immune attack on cancer cells; given as 2 cycles before noon to assess infusion timing impact. Source: Summary of Web Search.
Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM
Summary: PD-1/PD-L1 pathway inhibitor (e.g., pembrolizumab) enhancing immune response against NSCLC; administered as 4 cycles after 3 PM to evaluate timing-dependent efficacy. Source: Summary of Web Search.
Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM
Summary: PD-1/PD-L1 blocking agent reactivating T-cell immune responses against tumor cells; given as 4 cycles before noon to test morning dosing schedule effects. Source: Summary of Web Search.

Key Inclusion

Metastatic non-small cell lung cancer (Cohort 1A/1B)
Resectable head and neck squamous cell carcinoma (Cohort 2A/2B)
Written informed consent and HIPAA authorization obtained
Willing and able to comply with study procedures
Age ≥ 18 years at consent

Key Exclusion

Current steroid use (prednisone ≥10 mg equivalent) not discontinuable 7 days before treatment
Prior ICI (PD-1/PD-L1/CTLA4) therapy within 6 months of screening
Currently participating in another treatment clinical trial

NCT07778316

A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)

Organization/Sponsor: Amgen

Example patient: A 62-year-old man with relapsed extensive-stage SCLC after one platinum-based chemotherapy regimen, ECOG PS 1, measurable disease, and no prior immunotherapy or DLL3-targeted treatment.

Phase 3

Interventions

Biologic - Bispecific T-cell Engager (BiTE): Tarlatamab
Summary: Bispecific antibody binding DLL3 on SCLC tumor cells and CD3 on T-cells, redirecting T-cell mediated killing of tumor cells; FDA-approved for relapsed extensive-stage SCLC after platinum chemotherapy. This trial compares subcutaneous vs intravenous administration. Sources: FDA label, NCI Thesaurus, Web Search summary.

Key Inclusion

Histologically confirmed SCLC with progression or relapse
Progressed after 1 platinum-based regimen
Measurable disease per RECIST 1.1
ECOG PS 0 or 1
Life expectancy ≥ 12 weeks
Adequate organ function
Age ≥ 18 years
CNS metastases allowed per protocol

Key Exclusion

Prior NSCLC or mixed SCLC/NSCLC histology
Myocardial infarction or CHF within 6 months
History of arterial thrombosis within 6 months
Non-infectious pneumonitis/ILD requiring steroids
Other malignancy within past 2 years
More than 1 prior line of anticancer therapy for SCLC
Prior DLL3-targeted therapy or tarlatamab trial participation
Uncontrolled pleural/pericardial effusion or ascites

NCT07783477

A Phase I Trial for R/R MetAstatic DLL3+ Cancers Utilizing Armored CAR T Cells (ARMADA) Genomic-based

Organization/Sponsor: Memorial Sloan Kettering Cancer Center

Example patient: A 62-year-old man with relapsed extensive-stage small cell lung cancer, DLL3-positive by IHC, ECOG 1, previously treated with platinum-based chemoimmunotherapy, with stable treated brain metastases and normal organ function.

Phase I

Interventions

Biological/Cell Therapy: DLL3-SAVVYZ-IL18 CAR T cell
Summary: Autologous CAR T-cell therapy engineered to target DLL3-expressing tumor cells, armored with IL-18 to enhance T-cell activity; intended for relapsed/refractory SCLC and other DLL3+ neuroendocrine tumors. Source: Summary of Web Search.

Key Inclusion

DLL3+ neuroendocrine tumors including SCLC, LCNEC, GEP-NETs and others
Progressed after at least one prior systemic therapy including platinum-based regimen
Measurable disease per RECIST 1.1
Age >18 years
ECOG performance status 0-1
Adequate hematologic, hepatic, renal, cardiac, pulmonary function
Stable/treated CNS metastases permitted
Life expectancy ≥12 weeks

Key Exclusion

Primary CNS malignancies (e.g., GBM)
Symptomatic or progressing CNS metastases
Active HIV, hepatitis B or C infection
Uncontrolled systemic infection
Autoimmune disease requiring systemic immunosuppression
NYHA III/IV heart failure or recent MI
Unresolved immune-related toxicities (grade ≥2) or pneumonitis
Pregnant or lactating women

NCT07777822

A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308) Genomic-based

Organization/Sponsor: Revolution Medicines, Inc.

Example patient: A 62-year-old man with newly diagnosed metastatic non-squamous NSCLC harboring a RAS G12D mutation, ECOG status 1, no prior systemic therapy, and no brain metastases, eligible for first-line treatment.

Phase 3

Interventions

Chemotherapy: Pemetrexed + Cisplatin/Carboplatin
Summary: Platinum-based chemotherapy doublet that inhibits DNA synthesis and repair via platinum-DNA adducts, causing apoptosis in NSCLC cells. Source: NCI Thesaurus.
Biologic (Immunotherapy): Pembrolizumab
Summary: Humanized monoclonal antibody blocking PD-1 receptor to enhance T-cell mediated antitumor immunity; FDA-approved for NSCLC among other cancers. Source: FDA label, NCI Thesaurus.
Placebo: Placebo
Summary: Inactive comparator substance used to blind treatment assignment in trial arms. Source: NCI Thesaurus.
Small Molecule Inhibitor: zoldonrasib
Summary: Oral covalent tri-complex inhibitor selectively targeting KRAS G12D mutation, blocking downstream oncogenic signaling and enhancing antitumor immune response. Source: NCI Thesaurus.

Key Inclusion

Age ≥18 years with informed consent
ECOG performance status 0 or 1
Previously untreated metastatic non-squamous NSCLC
Known PD-L1 status
Documented RAS G12D mutation
Measurable disease per RECIST v1.1
Adequate organ function
Able to take oral medications

Key Exclusion

Prior systemic anticancer therapy for metastatic NSCLC
Prior RAS-directed therapy
Untreated CNS metastases
Conditions impairing drug absorption
Major surgery within 28 days of randomization
Unable/unwilling to comply with study procedures