Clinical Trials for Small Cell Lung Cancer

A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 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 stage IV squamous or nonsquamous NSCLC, ECOG 0–1, and no alteration warranting approved first-line targeted therapy receive investigational EIK1001, a TLR7/8 agonist, plus pembrolizumab and carboplatin with paclitaxel (squamous) or pemetrexed (nonsquamous). The study has no standard-of-care-only control arm.

ClinicalTrials.gov ID: NCT06246110

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

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 metastatic squamous NSCLC who have progressed after platinum chemotherapy and at least 12 weeks of PD-1/PD-L1–based therapy are randomized to gotistobart or docetaxel. Gotistobart is an investigational anti-CTLA-4 antibody designed to enhance tumor regulatory T-cell depletion.

ClinicalTrials.gov ID: NCT05671510

A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

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 metastatic nonsquamous NSCLC and no actionable genomic alteration receive platinum–pemetrexed chemotherapy followed by pemetrexed maintenance, combined with investigational livmoniplimab (which inhibits activation of TGF-β1) plus budigalimab (anti–PD-1), budigalimab alone in dose selection, or pembrolizumab (anti–PD-1).

ClinicalTrials.gov ID: NCT06236438

A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)

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 nonsquamous NSCLC, ECOG 0–1, and no actionable driver with an approved first-line targeted therapy receive a priming dose of volrustomig, an investigational PD-1/CTLA-4 bispecific antibody, followed by one of two volrustomig dosing regimens with carboplatin and pemetrexed. There is no standard-of-care comparator arm.

ClinicalTrials.gov ID: NCT06448754

A Phase 2, Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens 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

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 treated, locally advanced or metastatic c-Met–overexpressing, EGFR-wild-type nonsquamous NSCLC are randomized to one of two intravenous telisotuzumab vedotin regimens. Telisotuzumab vedotin is a c-Met–directed antibody–drug conjugate that delivers the microtubule-disrupting payload monomethyl auristatin E.

ClinicalTrials.gov ID: NCT06568939

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: Adults with previously treated, locally advanced or metastatic nonsquamous NSCLC with centrally confirmed c-Met overexpression and EGFR wild-type disease are randomized to telisotuzumab vedotin or docetaxel. Telisotuzumab vedotin is a c-Met–directed antibody–drug conjugate that delivers the microtubule inhibitor monomethyl auristatin E.

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 ECOG 0–1 and previously treated, refractory, locally advanced unresectable or metastatic solid tumors across multiple tumor-specific cohorts receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks. This investigational HER3-targeted antibody–drug conjugate delivers an exatecan-derived topoisomerase I inhibitor payload.

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 previously untreated, locally advanced unresectable or metastatic EGFR-mutated nonsquamous NSCLC and ECOG 0–1 are randomized to osimertinib alone or osimertinib plus telisotuzumab adizutecan. Telisotuzumab adizutecan is an investigational c-Met–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor.

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 ECOG 0–1 and relapsed/refractory extensive-stage small-cell lung cancer after at least two treatment lines, or extrapulmonary or pulmonary large-cell neuroendocrine carcinoma after platinum-based therapy, receive intravenous obrixtamig (BI 764532) at one of two doses. A separate expansion cohort enrolls patients with DLL3-high extrapulmonary neuroendocrine carcinoma; obrixtamig is an investigational DLL3/CD3 bispecific T-cell engager.

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: Adults with previously untreated extensive-stage small cell lung cancer, ECOG 0–1, and measurable disease receive four cycles of platinum–etoposide plus durvalumab, followed by maintenance durvalumab and investigational ceralasertib, an ATR inhibitor targeting the DNA-damage response. Treated, stable brain metastases are permitted.

ClinicalTrials.gov ID: NCT04699838