Clinical Trials for Non-Small Cell Lung Cancer

A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic 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.

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 adults with metastatic, EGFR/ALK/ROS1-negative NSCLC who have progressed after prior immune checkpoint inhibitor and platinum chemotherapy, and who have a resectable tumor lesion and good performance status. Patients receive LN-145, an autologous tumor-infiltrating lymphocyte (TIL) therapy that reinfuses expanded tumor-reactive T cells following lymphodepleting chemotherapy, aiming to stimulate anti-tumor immunity.

ClinicalTrials.gov ID: NCT04614103

A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-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: This trial enrolls adults with advanced NSCLC harboring EGFR mutations—including exon 20 insertions, classical (Ex19del, L858R), uncommon, or T790M drug-resistant mutations—to receive oral PLB1004, a novel irreversible EGFR tyrosine kinase inhibitor designed for broad activity across EGFR mutations with selectivity over wild-type EGFR.

ClinicalTrials.gov ID: NCT06046495

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

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant 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.

TrialFetch AI summary: This trial involves patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations and evaluates the safety and efficacy of ORIC-114, a selective irreversible inhibitor targeting EGFR exon 20 mutations, in combination with amivantamab, a bispecific EGFR and MET receptor-directed antibody.

ClinicalTrials.gov ID: NCT06816992

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

A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

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 previously untreated, advanced or metastatic non-squamous NSCLC harboring a KRAS G12C mutation (ECOG 0-1), this study evaluates the KRAS G12C inhibitor divarasib in combination with pembrolizumab (with or without platinum-based chemotherapy and pemetrexed). Key exclusions include prior KRAS G12C inhibitor use, squamous histology, and untreated CNS metastases.

ClinicalTrials.gov ID: NCT05789082

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 Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic 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: This trial is enrolling adults with metastatic solid tumors harboring KRAS G12D or G12V mutations who have progressed after standard therapies and are HLA-compatible for KRAS TCRs, to receive autologous T cells genetically engineered with anti-KRAS TCRs plus a KRAS-targeted adenoviral vaccine (GRT-C903) and mRNA boost (GRT-R904) following lymphodepletion. The goal is to elicit anti-tumor immune responses by targeting KRAS-mutant tumor cells with cellular therapy and vaccination.

ClinicalTrials.gov ID: NCT06253520