Clinical Trials for Small Cell Lung Cancer

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced 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.

TrialFetch AI summary: Adults with advanced/metastatic solid tumors (select cohorts: 2L+ cutaneous melanoma, EGFR-mutated or EGFR/ALK/ROS1–negative NSCLC, rare melanomas, other solid tumors; and in combination: 2L+ melanoma and HER2‑negative metastatic breast cancer) receive the HER3-targeting antibody–drug conjugate BNT326 (topoisomerase I payload) as monotherapy or combined with BNT327, a bispecific anti–PD-L1/anti–VEGF-A antibody. Includes a dedicated drug–drug interaction cohort with CYP inhibitors (itraconazole or paroxetine).

ClinicalTrials.gov ID: NCT07070232

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1)

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 advanced/metastatic EGFR-mutant NSCLC (ex19del/L858R), ECOG 0–1, after prior EGFR TKI; Part B requires C797X resistance mutation. Single‑agent DZD6008, an oral fourth‑generation, mutant‑selective EGFR TKI with designed activity against C797X (including C797S) and CNS penetration, is given once daily with dose escalation then expansion.

ClinicalTrials.gov ID: NCT06905197

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

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

TrialFetch 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.

TrialFetch 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

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.

TrialFetch 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

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.

TrialFetch 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 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.

TrialFetch 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