Clinical Trials for Non-Small Cell Lung Cancer

A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

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 study enrolls adults with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have not received prior therapy for advanced disease, testing the KRAS G12C inhibitor adagrasib (MRTX849), alone or combined with pembrolizumab, versus pembrolizumab alone (phase 3 for PD-L1 TPS ≥50%).

ClinicalTrials.gov ID: NCT04613596

A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in 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.

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 NSCLC (ECOG 0-2, no EGFR/ALK mutations, predominantly PD-L1 ≥50%), who have detectable ctDNA after initial pembrolizumab, and randomizes those with persistent ctDNA at 6 weeks to either continued pembrolizumab monotherapy (a PD-1 inhibitor) or pembrolizumab combined with platinum-based chemotherapy.

ClinicalTrials.gov ID: NCT04093167

Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant 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: This trial enrolls adults with advanced or metastatic solid tumors harboring KRAS G12C mutations (including pretreated NSCLC and other solid tumors), who receive a combination of the investigational KRAS G12C inhibitors RMC-6291 and RMC-6236. Both agents specifically inhibit KRAS G12C mutant protein to suppress tumor growth, and eligibility includes both KRAS G12C inhibitor–naïve and previously treated patients, excluding those with primary CNS tumors or active brain metastases.

ClinicalTrials.gov ID: NCT06128551

Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

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 with advanced or recurrent NSCLC harboring EGFR exon 20 insertion mutations who have received at least one prior therapy, treating them with osimertinib 160 mg daily, an investigational third-generation irreversible EGFR tyrosine kinase inhibitor, to assess efficacy and safety in this mutation subset. Patients must have good performance status and measurable disease, with key exclusions including prior osimertinib, recent immunotherapy, untreated CNS metastases, and significant comorbidities.

ClinicalTrials.gov ID: NCT03191149

Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: This trial enrolls adults with metastatic or locally advanced KRAS G12C-mutant NSCLC who have progressed after anti-PD-(L)1 therapy (with or without prior platinum chemotherapy) and have not received prior KRAS G12C inhibitors. Patients receive sotorasib (KRAS G12C inhibitor) combined with ladarixin, a dual CXCR1/2 antagonist targeting IL-8 signaling to modulate the tumor microenvironment.

ClinicalTrials.gov ID: NCT05815173

A Feasibility Multicenter Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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 (ECOG 0-2) with locally advanced or metastatic cancers eligible for atezolizumab, investigating therapeutic drug monitoring-based personalized dosing of atezolizumab (anti-PD-L1 immune checkpoint inhibitor) as monotherapy or combined with other approved agents. Patients initially receive standard dosing, then transition to adaptive, lower-frequency fixed dosing based on plasma levels.

ClinicalTrials.gov ID: NCT06066138

A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With 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.

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 stage IV non-small cell lung cancer and well-controlled HIV on antiretroviral therapy who have not received prior systemic therapy for metastatic disease, and treats them with platinum-based doublet chemotherapy in combination with durvalumab (anti-PD-L1 antibody) and tremelimumab (anti-CTLA-4 antibody). Maintenance durvalumab (with or without pemetrexed for non-squamous histology) is given to responders after induction.

ClinicalTrials.gov ID: NCT04499053

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung 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 solid tumors harboring KRAS G12C mutations—particularly pancreatic, breast, uterine, or epithelial ovarian cancers, and non-small cell lung cancer with combined KRAS G12C and KEAP1 mutations—who have progressed after prior therapy, and treats them with the combination of adagrasib (a selective irreversible KRAS G12C inhibitor) and olaparib (a PARP inhibitor).

ClinicalTrials.gov ID: NCT06130254

A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin

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: Adult patients with NSCLC and measurable brain metastases eligible for immune checkpoint inhibitor therapy are randomized to receive standard ICI treatment alone or in combination with targeted blood-brain barrier opening using Exablate focused ultrasound, a device-based method to enhance drug delivery to brain lesions.

ClinicalTrials.gov ID: NCT05317858

KB707-02: a Phase 1/2 Study of Inhaled KB707 in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: This study enrolls adults with advanced (stage 3 or 4) NSCLC or other solid tumors affecting the lungs who have progressed after, are intolerant of, or have refused standard therapy, and who have measurable lung lesions and good performance status. Treatment is with inhaled KB707, a gene therapy delivering IL-12 and IL-2 via a non-integrating HSV-1 vector to enhance local anti-tumor immunity, either as monotherapy or in combination with pembrolizumab and/or chemotherapy.

ClinicalTrials.gov ID: NCT06228326