Clinical Trials for Small Cell Lung Cancer

A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression

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.

TrialFetch AI summary: Adults with previously untreated stage IV squamous or nonsquamous NSCLC, PD-L1 tumor proportion score >50%, and ECOG performance status 0–1 are randomized to intravenous ivonescimab or pembrolizumab. Ivonescimab is an investigational bispecific antibody targeting PD-1 and VEGF-A.

ClinicalTrials.gov ID: NCT06767514

A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)

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.

TrialFetch AI summary: For patients with EGFR-mutated, locally advanced or metastatic nonsquamous NSCLC with extracranial progression on osimertinib and no prior non-EGFR-TKI systemic therapy for metastatic disease, this trial compares datopotamab deruxtecan (Dato-DXd) alone or with continued osimertinib against platinum–pemetrexed chemotherapy. Dato-DXd is a TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06417814

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

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.

TrialFetch AI summary: For patients with previously untreated, unresectable stage IIIB–IIIC or metastatic KRAS G12C-mutant NSCLC, this trial compares the selective KRAS G12C inhibitor olomorasib versus placebo added to first-line pembrolizumab-based therapy. Patients with PD-L1 expression ≥50% receive pembrolizumab alone as the backbone; those in the predominantly nonsquamous cohort receive pembrolizumab, pemetrexed, and platinum chemotherapy regardless of PD-L1 expression.

ClinicalTrials.gov ID: NCT06119581

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic 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.

TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced, metastatic, or recurrent nonsquamous NSCLC harboring an EGFR exon 19 deletion or L858R mutation are randomised to first-line osimertinib alone or with datopotamab deruxtecan. Datopotamab deruxtecan is a TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06350097

KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV 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

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.

TrialFetch AI summary: Adults with untreated stage IV squamous or nonsquamous NSCLC and ECOG performance status 0–1 are randomized to pembrolizumab plus patritumab deruxtecan, an investigational HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, or pembrolizumab plus histology-appropriate carboplatin-based chemotherapy.

ClinicalTrials.gov ID: NCT06731907

AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)

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.

TrialFetch AI summary: For patients with previously untreated, unresectable stage IIIB/IIIC or metastatic NSCLC and PD-L1 expression ≥50%, this trial compares pembrolizumab alone with pembrolizumab plus sigvotatug vedotin. Sigvotatug vedotin is an investigational integrin β6–targeting antibody–drug conjugate that delivers the microtubule-disrupting payload MMAE.

ClinicalTrials.gov ID: NCT06758401

KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous 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

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.

TrialFetch AI summary: Adults with stage IV nonsquamous NSCLC progressing after anti-PD-(L)1 therapy and platinum chemotherapy are randomized to docetaxel or one of two antibody–drug conjugates: raludotatug deruxtecan (CDH6-targeted) or ifinatamab deruxtecan (B7-H3-targeted), both delivering a topoisomerase I inhibitor. Patients must have ECOG 0–1 and no indication for first-line EGFR-, ALK-, or ROS1-directed therapy.

ClinicalTrials.gov ID: NCT06780085

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

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.

TrialFetch AI summary: This trial enrolls adults with previously untreated, PD-L1-high metastatic NSCLC without actionable drivers for approved first-line targeted therapy and with ECOG performance status 0–1. It compares first-line rilvegostomig, an investigational bispecific antibody targeting PD-1 and TIGIT, with pembrolizumab monotherapy.

ClinicalTrials.gov ID: NCT06868277

KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV 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

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.

TrialFetch AI summary: Adults with stage IV squamous NSCLC that has progressed after anti-PD-(L)1 therapy and platinum-based chemotherapy are randomized to raludotatug deruxtecan (a cadherin-6–targeted ADC), ifinatamab deruxtecan (a B7-H3–targeted ADC), or docetaxel. Both ADCs deliver a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06780098

A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies

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.

TrialFetch AI summary: Adults with previously treated, advanced or metastatic NSCLC harboring homozygous MTAP deletion and ECOG performance status 0–1 are randomized to one of two doses of oral BMS-986504 monotherapy. BMS-986504 is designed to inhibit the PRMT5–MTA complex that forms in MTAP-deleted tumors; there is no standard-of-care control arm.

ClinicalTrials.gov ID: NCT06855771