Clinical Trials for Non-Small Cell Lung Cancer

A Single-Arm Phase 2 Study of Daratumumab Subcutaneous (SC) in Previously Treated STK11/LKB1 Mutated 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 enrolls adults with metastatic or unresectable NSCLC harboring STK11/LKB1 mutations who have progressed after immunotherapy, platinum doublet chemotherapy, and any indicated targeted therapy; patients receive subcutaneous daratumumab, a CD38-targeting monoclonal antibody with immunomodulatory and cytotoxic activity, until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT05807048

KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV 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: This trial enrolls adults with previously untreated stage IV squamous or non-squamous NSCLC (without targetable driver mutations) to receive pembrolizumab plus chemotherapy combined with an investigational immunotherapy or antibody-drug conjugate targeting TIGIT (vibostolimab), CD27 (boserolimab), ILT4 (MK-4830), ILT3 (MK-0482), B7-H3 (I-DXd), or HER3 (HER3-DXd). Patients must have available tumor tissue and good organ function; those with active CNS disease, significant comorbidities, or prior systemic therapy for metastatic NSCLC are excluded.

ClinicalTrials.gov ID: NCT04165070

A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy

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: Eligible patients are adults with advanced non-squamous NSCLC whose disease has progressed after at least one prior checkpoint inhibitor-based regimen, without targetable driver mutations or uncontrolled CNS disease. Treatment consists of atezolizumab (PD-L1 inhibitor) combined with tocilizumab (an IL-6 receptor blocker thought to counteract resistance to immunotherapy).

ClinicalTrials.gov ID: NCT04691817

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

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 previously treated, locally advanced or metastatic, HER2 IHC 3+ solid tumors (excluding biliary tract cancers) who have progressed after at least one prior systemic therapy and lack standard treatment options; patients receive zanidatamab, a bispecific antibody targeting two HER2 epitopes. Eligible patients must have measurable disease, ECOG 0–1, and no active CNS metastases.

ClinicalTrials.gov ID: NCT06695845

A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion

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 unresectable or metastatic solid tumors harboring homozygous MTAP deletion (biopsy-amenable, ECOG 0-1) are eligible to receive MRTX1719, a selective PRMT5 inhibitor targeting the PRMT5-MTA complex, as monotherapy or in combination with standard therapies in expansion cohorts. Prior PRMT5 or MAT2A inhibitor therapy is excluded.

ClinicalTrials.gov ID: NCT05245500

A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable 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: This trial enrolls adults with locally advanced or metastatic non-small cell lung cancer—including EGFR-mutant disease post-EGFR TKI, KRAS-G12C-mutant after KRAS-G12C inhibitor, and EGFR-wildtype post-systemic therapy—to receive HER3-DXd (patritumab deruxtecan), an antibody-drug conjugate targeting HER3 and delivering a topoisomerase I inhibitor payload. Treatment is given intravenously every three weeks, with safety, dosing, and activity being evaluated across molecular subtypes.

ClinicalTrials.gov ID: NCT03260491

A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic 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: Eligible patients are adults with advanced or metastatic EGFR-mutant NSCLC who have progressed after at least 4 months on prior osimertinib. This trial compares quaratusugene ozeplasmid—an IV lipid nanoparticle gene therapy delivering the TUSC2 tumor suppressor gene—plus ongoing osimertinib versus standard platinum-based chemotherapy.

ClinicalTrials.gov ID: NCT04486833

Phase II Study of Adagrasib + Stereotactic Radiosurgery (SRS) for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated Brain Metastases

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 metastatic KRAS G12C-mutated NSCLC and untreated brain metastases (up to 10 lesions, none >3 cm), who are either treatment-naïve or have received up to two prior lines of therapy, to receive combination therapy with the selective KRAS G12C inhibitor adagrasib plus stereotactic radiosurgery. Prior KRAS G12C inhibitor therapy is not allowed.

ClinicalTrials.gov ID: NCT06248606

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

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 treatment-naive adults with advanced nonsquamous NSCLC that is KRAS p.G12C positive and PD-L1 negative, randomizing them to receive either sotorasib (a KRAS G12C inhibitor) plus carboplatin/pemetrexed or pembrolizumab plus carboplatin/pemetrexed.

ClinicalTrials.gov ID: NCT05920356

A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With Advanced or Metastatic 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 adults with advanced or metastatic ER+/HER2- breast cancer who have progressed after endocrine therapy and a CDK4/6 inhibitor, as well as selected patients with castration-resistant prostate cancer or non–small-cell lung cancer refractory to standard treatments. Participants receive PF-07248144, a selective KAT6A/B histone acetyltransferase inhibitor, as monotherapy or in combination with endocrine therapy or other investigational agents.

ClinicalTrials.gov ID: NCT04606446