Clinical Trials for Small Cell Lung Cancer

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

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: Single-arm study for adults with newly diagnosed advanced/metastatic NSCLC with PD-L1 ≥1% and no prior metastatic systemic therapy, testing intravenous trabedersen (OT-101)—an antisense oligonucleotide targeting TGF-β2 to reduce tumor immune suppression—combined with fixed-dose pembrolizumab. Phase 1 identifies the RP2D of OT-101 (4-days-on/10-days-off IV schedule) with pembrolizumab Q6W, followed by phase 2 assessing efficacy.

ClinicalTrials.gov ID: NCT06579196

MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor

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 histiocytic neoplasms (including ECD, LCH, histiocytic sarcoma, Rosai-Dorfman) lacking actionable BRAF/MAP2K alterations or post–BRAF/MEK, plus high‑risk MDS/CMML/MF post‑standard therapy, and multiple relapsed/refractory lymphomas/CLL after ≥2 prior lines, receive oral Q702 (adrixetinib), a TAM kinase (AXL/MERTK) and CSF1R inhibitor given week-on/week-off. The trial assesses safety, RP2D, and preliminary efficacy across disease-specific cohorts.

ClinicalTrials.gov ID: NCT06712810

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

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 select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified 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.

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 NSCLC harboring centrally confirmed NECTIN4 gene amplification (non-squamous and squamous cohorts), previously treated with up to 3 prior lines (including prior platinum/IO or appropriate targeted therapy for actionable drivers), receive zelenectide pevedotin (BT8009) monotherapy. BT8009 is a Nectin-4–targeted Bicycle Toxin Conjugate delivering MMAE; key exclusions include prior MMAE, active/untreated CNS mets, significant ocular disease, and active ILD/pneumonitis.

ClinicalTrials.gov ID: NCT06933329

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