Clinical Trials for Small Cell Lung Cancer

A Phase II Trial of GT103 in Combination With Pembrolizumab in STK11 Mutant 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.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: Adults with advanced/metastatic STK11-mutant NSCLC who have progressed on a pembrolizumab-containing regimen yet are appropriate to continue pembrolizumab receive pembrolizumab plus GT103, a first-in-class anti–complement factor H (CFH) IgG3 monoclonal antibody that enhances complement activation and antitumor phagocytosis. Key exclusions include active/untreated brain mets and actionable oncogenic drivers (EGFR/ALK/ROS1/RET/MET/NTRK).

ClinicalTrials.gov ID: NCT07017829

A Phase 1b/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody-Drug Conjugate (ADC), in Combination With Atezolizumab With or Without Carboplatin as First-line Induction or Maintenance, in Subjects With Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)

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.

HealthScout AI summary: Adults with extensive-stage SCLC either starting first-line therapy or entering maintenance after carboplatin/etoposide/atezolizumab receive the B7-H3–targeted ADC ifinatamab deruxtecan (DXd topoisomerase I payload) plus atezolizumab, with carboplatin added during induction for treatment‑naive patients; key exclusions include prior B7-H3 therapy, uncontrolled brain mets, ILD/pneumonitis, and active autoimmune disease. The trial evaluates safety and dose of I-DXd in combination regimens and explores efficacy as induction and/or maintenance.

ClinicalTrials.gov ID: NCT06362252

A First in Human Dose Escalation and Cohort Expansion Study of DLL3-directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer

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.

HealthScout AI summary: Adults with relapsed/refractory extensive-stage small cell lung cancer or large cell neuroendocrine carcinoma (including combined histologies) after ≥1 prior therapy receive lymphodepleting fludarabine/cyclophosphamide followed by LB2102, an autologous DLL3-directed CAR T-cell therapy armored with a dominant-negative TGF-β receptor II to resist tumor microenvironment immunosuppression. Key exclusions include prior CAR-T or DLL3 therapy and uncontrolled CNS disease.

ClinicalTrials.gov ID: NCT05680922

An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Participants With Small Cell Lung Cancer

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.

HealthScout AI summary: Adults with extensive-stage/metastatic small cell lung cancer, including those previously treated with platinum or treatment-naïve, receive the DLL3-targeted antibody–drug conjugate ZL-1310 (topoisomerase I inhibitor payload) as monotherapy or combined with atezolizumab, with some arms adding carboplatin induction followed by ZL-1310 + atezolizumab maintenance. Appropriate for ECOG 0–1; excludes active/untreated brain mets (with later-part exceptions) and significant autoimmune/pulmonary comorbidities.

ClinicalTrials.gov ID: NCT06179069

DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With a Single Agent Chemotherapy for the Treatment of Patients With Relapsed/Refractory Small Cell Lung Cancer After Platinum-based Chemotherapy

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.

HealthScout AI summary: Adults with relapsed/refractory extensive-stage SCLC after platinum (and prior PD-1/PD-L1 if given) eligible for single-agent chemotherapy receive IV BI 764532, a DLL3×CD3 bispecific T‑cell engager, combined with chemotherapy (dose escalation) and then with topotecan (dose confirmation). Key exclusions include active/untreated brain mets and prior DLL3-directed T-cell therapies.

ClinicalTrials.gov ID: NCT05990738

A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer

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.

HealthScout AI summary: Adults with relapsed/refractory extensive-stage SCLC after ≥1 prior systemic therapy (including platinum) receive gocatamig (HPN328; trispecific DLL3×CD3 T‑cell engager with albumin-binding for half-life) as monotherapy or combined with ifinatamab deruxtecan (B7‑H3–targeted DXd ADC) or with durvalumab (PD‑L1 inhibitor). Key exclusions include uncontrolled effusions, significant/suspected ILD/pneumonitis, major cardiopulmonary disease/events, uncontrolled brain mets, active infections/viral hepatitis, and recent chemo/radiation; archival or fresh tumor tissue required.

ClinicalTrials.gov ID: NCT06780137

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer

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.

HealthScout AI summary: Adults with extensive-stage SCLC: Parts 1–2 enroll those progressed after ≥1 platinum regimen; Part 3 enrolls first-line patients after exactly one cycle of platinum/etoposide plus PD-(L)1. Investigational therapy combines tarlatamab (DLL3×CD3 bispecific T-cell engager) with YL201 (B7-H3–targeting topoisomerase I ADC) with or without anti–PD-L1 (atezolizumab or durvalumab).

ClinicalTrials.gov ID: NCT06898957

A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer

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.

HealthScout AI summary: Adults with DLL3-positive small cell lung cancer that has progressed after or is intolerant to standard therapies receive ZG006 (alveltamig), a trispecific T‑cell engager targeting two DLL3 epitopes and CD3, in a dose-escalation study. Suitable for ECOG 0–1 patients; key exclusions include active infections, recent immunosuppression, and prior severe immune-mediated events.

ClinicalTrials.gov ID: NCT06592638

Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers

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.

HealthScout AI summary: Adults with metastatic or inoperable somatostatin receptor–positive tumors (GI NETs, pheochromocytoma/paraganglioma, small cell lung, renal cell, and select head/neck cancers) confirmed by SSTR PET receive [212Pb]VMT-Alpha-NET, an SSTR2-targeted alpha-emitting radioligand (212Pb→212Bi) given IV every 8 weeks for up to 4 cycles, with an optional [203Pb] imaging/dosimetry lead-in. Excludes prior systemic radioligand therapy; allows treated/stable or asymptomatic CNS mets and requires adequate organ function.

ClinicalTrials.gov ID: NCT06479811

A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

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.

HealthScout AI summary: Adults with extensive-stage SCLC who achieved at least stable disease after 4–6 cycles of first-line platinum/etoposide plus atezolizumab or durvalumab receive maintenance PD-L1 inhibitor with or without iadademstat. Iadademstat is an oral covalent LSD1 (KDM1A) inhibitor that modulates SCLC neuroendocrine programs (e.g., activates NOTCH, suppresses ASCL1); treated/stable brain metastases and controlled HIV/HBV/HCV allowed.

ClinicalTrials.gov ID: NCT06287775