Clinical Trials for Small Cell Lung Cancer

A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Maintenance trial for adults with ES-SCLC who have CR/PR/SD after 3–4 cycles of carboplatin/etoposide/atezolizumab (ECOG 0–1; treated, asymptomatic brain mets allowed), testing atezolizumab ± hyaluronidase every 21 days combined with quaratusugene ozeplasmid (Reqorsa), a non-viral lipid nanoparticle gene therapy delivering TUSC2 tumor suppressor to restore tumor suppression, disrupt oncogenic signaling, induce apoptosis, and enhance anti-tumor immunity. RP2D of quaratusugene ozeplasmid is 0.12 mg/kg IV every 21 days.

ClinicalTrials.gov ID: NCT05703971

Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with newly diagnosed extensive-stage SCLC who have SD/PR/CR after 4 cycles of platinum doublet plus atezolizumab start maintenance atezolizumab (standard dosing) combined with oral valemetostat, an investigational dual EZH1/EZH2 inhibitor targeting H3K27me3 to suppress tumor proliferation. Key allowances include treated, controlled brain mets; key exclusions include recent consolidative chest RT, significant cardiac comorbidities/QTc prolongation, active infections, strong CYP3A modulators, and prior EZH inhibitor use.

ClinicalTrials.gov ID: NCT06807632

Safety and Efficacy of Ivonescimab and Chemotherapy Plus Stereotactic Radiosurgery (SRS) in the Treatment of Non-Small Cell Lung Cancer Brain Metastases

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with ECOG 0–1 squamous or non-squamous NSCLC and 1–3.5 cm brain metastases suitable for SRS receive investigational ivonescimab, a bispecific PD-1/VEGF antibody, with platinum-based chemotherapy followed by fractionated SRS. This single-arm study includes dose finding then expansion to assess safety and preliminary intracranial efficacy.

ClinicalTrials.gov ID: NCT07535463

A Pilot Study of Tepotinib + Ivonescimab in Patients With Advanced METex14 Skipping Positive NSCLC

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with measurable advanced or recurrent MET exon 14 skipping–positive NSCLC, ECOG 0–2, and no other actionable driver receive tepotinib, a selective MET tyrosine kinase inhibitor, plus ivonescimab, a bispecific PD-1/VEGF antibody. Prior MET inhibitor and checkpoint inhibitor therapy are permitted, but prior antiangiogenic therapy is excluded.

ClinicalTrials.gov ID: NCT07619339

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other 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 trial involves patients with metastatic or unresectable non-small cell lung cancer and other solid tumors who receive BL-B01D1, a bispecific antibody-drug conjugate targeting EGFR and HER3, designed with a novel topoisomerase I inhibitor payload. The study evaluates different dosing schedules to determine safety, tolerability, and efficacy, particularly aiming to optimize dosing based on promising response rates in EGFR-mutated NSCLC and other cancer types.

ClinicalTrials.gov ID: NCT05983432

A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies

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 trial involves adult patients with advanced solid tumors, including those with platinum-resistant ovarian cancer or cutaneous squamous cell carcinoma, assessing the safety and efficacy of OR502, a monoclonal antibody targeting LILRB2 on tumor-associated macrophages, alone and with cemiplimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT06090266

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol)

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: Eligible patients are adults with advanced or metastatic gastric/GEJ adenocarcinoma, NSCLC, or pancreatic ductal adenocarcinoma expressing CEACAM5, who have progressed after 1–3 prior systemic therapies. The trial investigates M9140, an antibody-drug conjugate targeting CEACAM5 and delivering a topoisomerase I inhibitor payload, as monotherapy in these populations.

ClinicalTrials.gov ID: NCT06710132

A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in 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 trial enrolls adults with advanced or metastatic solid tumors, including those with lesions amenable to intratumoral injection, to receive intratumoral tolododekin alfa (ANK-101), an anchored IL-12 conjugate that locally activates antitumor immunity, as monotherapy or in combination with cemiplimab for high-risk cutaneous squamous cell carcinoma. Patients must have progressed on or be ineligible for standard therapies.

ClinicalTrials.gov ID: NCT06171750