Clinical Trials for Small Cell Lung Cancer

A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours

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 ECOG 0–1 and advanced/metastatic unresectable solid tumors in selected cohorts: mesothelioma, metastatic pancreatic ductal adenocarcinoma, or KRAS G12C-mutated NSCLC. All receive investigational oral ODM-212, a pan-TEAD/Hippo pathway inhibitor targeting YAP/TAZ–TEAD signaling, combined respectively with ipilimumab/nivolumab, gemcitabine/nab-paclitaxel, or sotorasib.

ClinicalTrials.gov ID: NCT07563738

AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS 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 previously untreated, unresectable stage IIIB/IIIC or metastatic NSCLC and no known actionable genomic alterations receive PF-08634404, an investigational PD-1/VEGF bispecific antibody, plus either sigvotatug vedotin, an integrin β6–targeted MMAE antibody–drug conjugate, or another protocol-specified anticancer agent. The latter cohort requires PD-L1 TPS ≥1%.

ClinicalTrials.gov ID: NCT07227298

A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy

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 metastatic NSCLC harboring an osimertinib-sensitive EGFR mutation who have progressed after a third-generation EGFR TKI and received platinum chemotherapy or are ineligible for it receive ivonescimab, a PD-1/VEGF-A bispecific antibody, plus either datopotamab deruxtecan, a TROP2-directed topoisomerase I inhibitor antibody–drug conjugate, or osimertinib.

ClinicalTrials.gov ID: NCT07535437

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 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 measurable SCLC and ECOG 0–1 are eligible after progression or recurrence on platinum-based therapy; a separate cohort enrolls patients with extensive-stage SCLC who have received no more than one cycle of platinum chemotherapy. All receive tarlatamab, a DLL3-directed T-cell engager, plus ZL-1310, a DLL3-targeted antibody–drug conjugate carrying a topoisomerase I inhibitor; the extensive-stage cohort also receives durvalumab (anti-PD-L1).

ClinicalTrials.gov ID: NCT07531095

A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients 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: This study enrolls adults with previously untreated extensive-stage small-cell lung cancer and ECOG performance status 0–1 to receive YL201 plus atezolizumab. YL201 is an investigational B7-H3–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor; the study evaluates its safety and activity at different doses without an atezolizumab-only comparator.

ClinicalTrials.gov ID: NCT07407933

A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line 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: For patients with extensive-stage SCLC, this study evaluates first-line induction and/or maintenance regimens combining gocatamig, an investigational DLL3×CD3 T-cell engager, with ifinatamab deruxtecan, an investigational B7-H3-directed antibody–drug conjugate carrying a topoisomerase I inhibitor. Eligible patients are either untreated or have no progression after platinum–etoposide plus PD-1/PD-L1 therapy; regimens include atezolizumab maintenance and a carboplatin–etoposide–atezolizumab comparator.

ClinicalTrials.gov ID: NCT07227597

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally 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 aged 18–75 with measurable locally advanced or metastatic protocol-specified epithelial solid tumors, ECOG 0–1, and applicable molecular testing are eligible. Treatment is IV AVZO-1418, an EGFR/HER3-targeted bispecific antibody–drug conjugate delivering a topoisomerase I inhibitor payload, as monotherapy with potential protocol-defined combination cohorts.

ClinicalTrials.gov ID: NCT07038343

A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients 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 or metastatic solid tumors harboring specified RAS mutations, ECOG 0–1, generally without acceptable standard systemic options; a newly diagnosed pancreatic ductal adenocarcinoma cohort is also eligible. Patients receive oral ERAS-0015, a pan-RAS molecular glue that disrupts active RAS–effector interactions and inhibits MAPK signaling, alone or with other investigational anticancer agents.

ClinicalTrials.gov ID: NCT06983743

A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC

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 ES-SCLC, ECOG 0–1, and progression after standard chemotherapy receive lymphodepletion followed by DJI136, an autologous DLL3-targeted CAR-T therapy engineered with a dominant-negative TGF-β receptor to reduce T-cell suppression. Phase I permits prior DLL3-targeted therapy, whereas Phase II excludes it.

ClinicalTrials.gov ID: NCT07564401

A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult 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 solid tumors after progression on, or ineligibility for, standard therapies receive intravenous SIM0505 every 21 days. This CDH6-targeted antibody–drug conjugate delivers a topoisomerase-I inhibitor; dose optimization focuses on platinum-resistant ovarian, primary peritoneal or fallopian-tube cancer, clear-cell or papillary renal cell carcinoma, uterine serous carcinoma, and CDH6-expressing NSCLC adenocarcinoma without an actionable EGFR mutation.

ClinicalTrials.gov ID: NCT06792552