Clinical Trials for Small Cell Lung Cancer

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)

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: This trial compares proton craniospinal irradiation (pCSI) versus involved-field radiotherapy (IFRT) in adult patients with leptomeningeal metastasis from breast cancer or non-small cell lung cancer, focusing on overall survival and other CNS outcomes.

ClinicalTrials.gov ID: NCT06500481

A Phase Ib Study of Vismodegib and Atezolizumab in Patients with Advanced Non-Small Cell Lung Cancer (ML43922)

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: The trial targets patients aged 18 and older with recurrent or metastatic non-small cell lung cancer who have exhausted curative treatments, investigating a combination of vismodegib, an inhibitor of the Hedgehog signaling pathway, and atezolizumab, a PD-L1 immune checkpoint inhibitor. Participants must have measurable disease and will receive treatment in a non-randomized, open-label single arm to evaluate safety, tolerability, and efficacy.

ClinicalTrials.gov ID: NCT06616623

Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer

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: This trial targets vulnerable or older adults aged 70 or above with advanced non-small cell lung cancer (NSCLC) and a PD-L1 TPS of less than 50%, assessing the safety and efficacy of reduced dose chemotherapy with carboplatin and paclitaxel or pemetrexed (depending on histology), in combination with Pembrolizumab, an anti-PD-1 antibody therapy.

ClinicalTrials.gov ID: NCT06731413

A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

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: This trial enrolls patients with previously untreated, locally advanced or metastatic non-squamous NSCLC with a documented KRAS G12C mutation, randomizing them to receive adagrasib (a selective KRAS G12C inhibitor) plus pembrolizumab and platinum-pemetrexed chemotherapy versus placebo plus pembrolizumab and chemotherapy. Patients may have asymptomatic, untreated brain metastases ≤ 20 mm; prior KRAS G12C inhibitor therapy is not allowed.

ClinicalTrials.gov ID: NCT06875310

LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients 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.

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: Adults with NSCLC are enrolled across advanced/metastatic, unresectable stage III after chemoradiotherapy, and resectable stage II–III settings, with eligibility varying by cohort. They receive BNT116, an mRNA vaccine encoding six NSCLC antigens to induce T-cell responses, alone or with cemiplimab, docetaxel, investigational CTLA-4 antibody BNT316, or anti-B7-H3/anti-HER3 antibody–drug conjugates; the resectable cohort receives BNT116 with cemiplimab and carboplatin–paclitaxel before surgery, then BNT116 plus cemiplimab afterward.

ClinicalTrials.gov ID: NCT05142189

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 As a Single Agent and in Combination Therapy in Patients with Selected 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.

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: Patients with selected advanced solid tumors receive STK-012 alone or with pembrolizumab, with some cohorts also receiving pemetrexed and carboplatin; most dose-escalation cohorts require prior standard therapy, while some expansion cohorts allow untreated metastatic disease, including PD-L1-negative NSCLC. STK-012 is an investigational IL-2 receptor α/β-biased partial agonist designed to preferentially stimulate antigen-experienced CD25-positive T cells.

ClinicalTrials.gov ID: NCT05098132

Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

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.

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: Patients with advanced RET-altered solid tumors, particularly locally advanced or metastatic RET fusion–positive NSCLC, receive oral vepafestinib, a brain-penetrant RET tyrosine kinase inhibitor targeting RET fusions and mutations, including resistance-associated variants. Patients with NSCLC may enroll with or without prior selective RET inhibitor exposure.

ClinicalTrials.gov ID: NCT04683250

A First-In-human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Administered by Parenteral Route in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3

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.

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: Adults with locally advanced or metastatic DLL3-positive small-cell lung cancer, pulmonary large-cell neuroendocrine carcinoma, or other neuroendocrine/small-cell carcinoma who have exhausted or are ineligible for standard therapy receive BI 764532 (obrixtamig) weekly or every 3 weeks. This investigational DLL3/CD3 bispecific antibody recruits T cells to DLL3-expressing tumor cells.

ClinicalTrials.gov ID: NCT04429087

A Phase Ib Study of AZD9291 (Osimertinib) and BC2059 (Tegavivint) As First-Line Therapy in Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

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.

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: Adults with metastatic EGFR exon 19 deletion– or L858R-mutant NSCLC who have not received an EGFR tyrosine kinase inhibitor receive first-line osimertinib plus investigational tegavivint, followed by osimertinib alone. Tegavivint inhibits Wnt/β-catenin signaling by binding TBL1 proteins.

ClinicalTrials.gov ID: NCT04780568

A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant 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.

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 patients with unresectable or metastatic KRAS G12C-mutant solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer, generally after standard therapy; a cohort includes previously untreated advanced NSCLC. Patients receive olomorasib, an oral inhibitor that binds inactive KRAS G12C, alone or with pembrolizumab, cetuximab, or pembrolizumab plus pemetrexed and platinum chemotherapy, depending on cohort.

ClinicalTrials.gov ID: NCT04956640