Clinical Trials for Non-Small Cell Lung Cancer

Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers

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 NSCLC, melanoma, endometrial cancer, or HNSCC who have progressed after standard therapies including prior anti-PD-1/L1 agents, and evaluates the combination of STC-15 (an oral METTL3 inhibitor targeting RNA methylation) plus toripalimab (anti-PD-1 antibody). Eligible patients must have measurable disease, ECOG 0–1, and no active CNS disease.

ClinicalTrials.gov ID: NCT06975293

Study of NMS-03305293, a Non-Trapping PARP1-Specific PARP Inhibitor in Relapsed Small Cell Lung Cancer

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 relapsing within 6 months after platinum–immunotherapy (and after tarlatamab if appropriate), up to three prior lines, receive oral NMS-03305293 (a PARP1-selective, non-trapping PARP inhibitor) continuously with temozolomide days 1–5 of 28‑day cycles. Single-arm study focuses on safety/PK and preliminary activity in this heavily pretreated population with measurable disease and ECOG 0–2.

ClinicalTrials.gov ID: NCT06931626

RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I/II Study of AMG757 / Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3

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 DLL3-expressing or DLL3-prevalent tumors (including SCLC, LCNEC, high-grade neuroendocrine tumors, and select NSCLC/other histologies) receive the DLL3-directed bispecific T‑cell engager tarlatamab plus external-beam radiation, given concurrently or sequentially depending on safety. Key risks include CRS/ICANS; includes extracranial and cranial RT cohorts with allowance for treated/stable brain mets and selected brain lesions.

ClinicalTrials.gov ID: NCT06814496

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors

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 refractory to standard therapy (mCRPC, metastatic breast cancer subtypes including TNBC, HR+/HER2− or HER2-low, HR−/HER2+, NSCLC, CRC, PDAC) receive MBRC-201, an investigational antibody‑drug conjugate targeting a tumor-associated antigen and delivering a likely topoisomerase I inhibitor payload. Requires ECOG 0–2 and measurable disease in expansion/Phase 2; excludes active CNS disease and prior camptothecin‑payload ADCs in later phases.

ClinicalTrials.gov ID: NCT07145255

A Phase 1b Study of Gilteritinib in Participants With Locally Advanced or Metastatic NSCLC With ALK Rearrangement After Prior Treatment With an ALK Inhibitor

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 ALK-rearranged, locally advanced/metastatic NSCLC who have progressed on prior ALK TKI (including post-alectinib or post-lorlatinib) receive oral gilteritinib, a FLT3/ALK tyrosine kinase inhibitor, with intra-patient dose escalation based on tolerability and disease control. Excludes symptomatic CNS/LM disease and significant cardiac/QTc risks; assesses safety with secondary efficacy endpoints (including intracranial response).

ClinicalTrials.gov ID: NCT07140016

A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With Active EGFR Mutation Locally Advanced or Metastatic NSCLC

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 adults with unresectable locally advanced or metastatic NSCLC harboring active EGFR mutations, including C797S, who have progressed on osimertinib or another third-generation EGFR-TKI, receiving the investigational fourth-generation EGFR tyrosine kinase inhibitor H002 to assess its safety and preliminary anti-tumor activity.

ClinicalTrials.gov ID: NCT05519293

A Phase 1, Open-Label Study of ABSK112 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Non-Small Cell Lung Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 evaluates ABSK112, a small molecule targeting EGFR exon 20 insertion mutations, in patients with locally advanced or metastatic non-small cell lung cancer characterized by these mutations, focusing on its safety, tolerability, and pharmacokinetics. The study involves dose escalation and an expansion cohort, enrolling adults with measurable disease and a life expectancy of at least three months.

ClinicalTrials.gov ID: NCT06225804

A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO301, an EGFR-Targeting Antibody-Drug Conjugate, in Adult Patients With Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: The trial involves adult patients with advanced or metastatic solid tumors, including those with non-small cell lung cancer (NSCLC), breast, and colorectal cancer, particularly focusing on NSCLC with EGFR mutations during dose expansion, testing CPO301, an EGFR-targeting antibody-drug conjugate.

ClinicalTrials.gov ID: NCT05948865

A Phase 1/2, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JIN-A02 in Patients With EGFR Mutant Advanced Non-small Cell Lung Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: The trial targets patients with advanced NSCLC with EGFR mutations who have progressed after prior EGFR-TKI (including osimertinib) and/or platinum-based chemotherapy, assessing the safety and efficacy of JIN-A02, a fourth-generation EGFR tyrosine kinase inhibitor designed to overcome resistance related to EGFR mutations such as C797S.

ClinicalTrials.gov ID: NCT05394831

Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer

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 involves patients with oligoprogressive non-small cell lung cancer who previously received first-line systemic therapies, evaluating the safety of adding the antimicrobial agent vancomycin to precision hypofractionated radiation therapy. Vancomycin, known for inhibiting bacterial cell wall synthesis, is used here to potentially reduce infections and modulate the immune response.

ClinicalTrials.gov ID: NCT03546829