Clinical Trials for Small Cell Lung Cancer

A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-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 locally advanced or metastatic NSCLC and ECOG 0–1 receive intratumoral tolododekin alfa (ANK-101), a tumor-retained IL-12 formulation intended to stimulate T-cell and natural killer cell activity. Patients whose disease progressed after PD-1/PD-L1 blockade and platinum chemotherapy also receive investigational anti-PD-1 antibody cetrelimab; those untreated for advanced disease receive an investigator-selected approved anti-PD-1/PD-L1 antibody.

ClinicalTrials.gov ID: NCT07027514

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine 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 measurable locally advanced or metastatic SCLC or other neuroendocrine tumors (≥10% neuroendocrine histology) who have failed or cannot receive standard therapy are eligible; patients with SCLC must have received platinum therapy, and prior topoisomerase inhibitor–based antibody–drug conjugates are excluded. All patients receive intravenous BL-M14D1, an investigational DLL3-targeting antibody–drug conjugate that delivers the topoisomerase I inhibitor Ed-04, every 3 weeks.

ClinicalTrials.gov ID: NCT07080242

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

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 small cell lung cancer that has progressed or recurred after at least one prior therapy receive tarlatamab plus intravenous AB248. Tarlatamab is a DLL3-targeted bispecific T-cell engager; AB248 is an investigational CD8β-targeted IL-2 fusion protein designed to preferentially stimulate CD8-positive T cells.

ClinicalTrials.gov ID: NCT07037758

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients With DLL3-Expressing Tumors Including 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 measurable recurrent or progressive small cell lung cancer after standard therapy, including platinum chemotherapy and usually PD-1/PD-L1 inhibition, receive IDE849 in dose-escalation and expansion cohorts. IDE849 is an investigational antibody–drug conjugate targeting DLL3 that delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT07174583

A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent 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 previously treated, measurable metastatic or locally advanced head and neck, lung, gastrointestinal, pancreatic, cervical, endometrial, or urothelial cancer receive STRO-004 alone or with pembrolizumab. STRO-004 is a tissue factor–targeted antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT07227168

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous 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 squamous tumors who have progressed after standard therapy or cannot receive it are eligible; expansion cohorts focus on squamous non-small cell lung cancer and head and neck squamous cell carcinoma. Treatment is oral ABBV-711, an investigational PARP7 inhibitor, alone or with intravenous budigalimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT07241039

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-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: Patients with metastatic KRAS G12C-mutant NSCLC who have progressed after or cannot tolerate platinum chemotherapy and PD-L1–targeted immunotherapy receive amivantamab, an EGFR/MET bispecific antibody, plus olomorasib, an investigational KRAS G12C inhibitor. Prior KRAS inhibitor treatment is excluded.

ClinicalTrials.gov ID: NCT07227025

A Phase 2 Study of DRP-104, a Glutamine Antagonist, in Patients With NFE2L2/KEAP1-altered 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

TrialFetch AI summary: Adults with advanced or recurrent NFE2L2- or KEAP1-altered NSCLC that has progressed after chemotherapy and immune checkpoint inhibition receive subcutaneous DRP-104 twice weekly. DRP-104 is a tumor-targeted prodrug of DON, a glutamine antagonist that inhibits multiple glutamine-utilizing enzymes.

ClinicalTrials.gov ID: NCT07249372

Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)

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 measurable SCLC progressing after at least one platinum-based regimen receive irinotecan plus oral cirtuvivint, an investigational CLK/DYRK kinase inhibitor that affects RNA splicing. Prior anti-PD-(L)1 therapy and prior irinotecan are permitted, except when irinotecan was stopped for treatment-related toxicity.

ClinicalTrials.gov ID: NCT07155200

A Phase 1a/1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion

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: Patients with incurable relapsed or refractory SCLC previously treated with radiation or platinum-based chemotherapy receive single-agent intravenous ST-001 on five consecutive days every three weeks. ST-001 is a fenretinide formulation; fenretinide binds retinol-binding protein 4 and has been shown in laboratory studies to alter sphingolipid metabolism.

ClinicalTrials.gov ID: NCT06922539