Clinical Trials for Small Cell Lung Cancer

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with previously treated, c-Met overexpressing, EGFR wildtype, locally advanced or metastatic non-squamous NSCLC, randomized to receive either telisotuzumab vedotin—an antibody-drug conjugate targeting c-Met—or standard docetaxel. Eligible patients must have had prior platinum-based chemotherapy and immunotherapy if appropriate, with stable CNS metastases permitted.

ClinicalTrials.gov ID: NCT04928846

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with untreated, locally advanced unresectable or metastatic EGFR-mutated non-squamous NSCLC (ECOG 0–1) are randomized to telisotuzumab adizutecan (c-Met–targeting ADC delivering a topoisomerase I inhibitor) plus fixed-dose osimertinib versus comparator regimens (osimertinib alone in Phase 2; standard of care in Phase 3), with c-Met IHC–based stratification. Key exclusions include prior/active ILD, leptomeningeal disease, and uncontrolled spinal cord compression.

ClinicalTrials.gov ID: NCT07005102

DAREON™-5: An Open-label, Multi-center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-targeting T Cell Engager, in Patients With Relapsed/Refractory Extensive-stage Small Cell Lung Cancer and in Patients With Other Relapsed/Refractory Neuroendocrine Carcinomas

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with relapsed/refractory extensive-stage SCLC (post ≥2 lines including platinum and, where standard, PD‑L1 inhibitor) or other high‑grade neuroendocrine carcinomas (including pulmonary LCNEC and DLL3‑high extrapulmonary NEC after ≥1 platinum) receive intravenous BI 764532, a DLL3/CD3 bispecific T‑cell engager redirecting T‑cell cytotoxicity to DLL3‑expressing tumors. Part 1 randomizes between two dose levels; Part 2 expands at the selected dose in centrally confirmed DLL3‑high extrapulmonary NEC.

ClinicalTrials.gov ID: NCT05882058

A Phase II Study of Chemo-Immunotherapy Followed by Durvalumab (MEDI4736) and Ceralasertib (AZD6738) in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Big Ten Cancer Research Consortium BTCRC-LUN18-363

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Untreated adults with extensive-stage SCLC (ECOG 0–1), including those with treated/stable brain metastases, receive induction platinum–etoposide plus durvalumab followed by maintenance durvalumab with ceralasertib. Ceralasertib is an oral ATR kinase inhibitor targeting the DNA damage response to potentiate cytotoxic and PD-L1–directed immunotherapy.

ClinicalTrials.gov ID: NCT04699838

A Phase 2 Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with relapsed SCLC after platinum-based first-line therapy (≤2 prior cytotoxic lines; ECOG 0–2; measurable disease; treated/stable CNS mets allowed) receive oral onvansertib, a selective ATP-competitive PLK1 inhibitor that induces G2/M arrest and apoptosis, given days 1–14 of 21-day cycles. Single-arm design with potential biomarker enrichment (e.g., TP53 mutation type, SCLC-Y, MYC expression); primary endpoint is objective response.

ClinicalTrials.gov ID: NCT05450965

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolls adults with advanced/metastatic solid tumors—HCC (Child-Pugh A), cervical, melanoma, recurrent/metastatic HNSCC, platinum‑resistant high‑grade serous ovarian, and nonsquamous NSCLC without actionable drivers—ECOG 0–1 and measurable disease. Investigational therapy pairs the B7‑H3–targeted topoisomerase‑I ADC DB‑1311 with either BNT327 (PD‑L1/VEGF‑A bispecific) for HCC/cervical/melanoma/HNSCC or with the TROP2‑directed topoisomerase‑I ADC DB‑1305 for NSCLC.

ClinicalTrials.gov ID: NCT06953089

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with locally advanced/metastatic NSCLC enrolled by biomarker and line: first-line AGA-negative with PD-L1 ≥50% get rilvegostomig (PD‑1/TIGIT bispecific) ± ramucirumab, first-line AGA-negative with PD-L1 1–49% get rilvegostomig + ramucirumab, and second-line AGA-positive nonsquamous post–targeted therapy get datopotamab deruxtecan (TROP2 ADC) + ramucirumab ± rilvegostomig. Designed to assess safety and antitumor activity across these combinations, excluding patients with active autoimmune disease, uncontrolled comorbidities, or unstable CNS disease.

ClinicalTrials.gov ID: NCT07098338

KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolls adults with previously untreated advanced/metastatic nonsquamous NSCLC harboring a KRAS G12C mutation (tumor tissue or ctDNA), requiring available archival/new non-irradiated tumor tissue and excluding prior KRAS-targeted therapy or active CNS disease. Randomizes first-line treatment to pembrolizumab + carboplatin/pemetrexed vs pembrolizumab plus MK-1084 (selective covalent KRAS G12C-GDP inhibitor) vs pembrolizumab + MK-1084 + cetuximab (EGFR antibody).

ClinicalTrials.gov ID: NCT07252739

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously untreated stage IV metastatic squamous NSCLC (ECOG 0–1; measurable disease; requires non-irradiated metastatic tumor tissue for sequencing; controlled HIV and treated/undetectable HBV/HCV allowed) receive first-line pembrolizumab plus carboplatin and a taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab maintenance. Participants are randomized double-blind to add V940 (mRNA-4157/intismeran autogene), an individualized lipid nanoparticle mRNA neoantigen vaccine encoding up to 34 patient-specific neoantigens to stimulate CD4+/CD8+ T-cell responses, versus placebo.

ClinicalTrials.gov ID: NCT07221474