Clinical Trials for Non-Small Cell Lung Cancer

A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory 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.

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: Adults with locally advanced or metastatic NSCLC (ECOG 0–1) with RECIST-measurable disease who have progressed on prior anti–PD-(L)1 therapy and have no remaining/acceptable standard metastatic options (treated stable brain metastases allowed) receive SAR445877 IV every 2 weeks. SAR445877 is a bifunctional fusion protein providing PD-1 blockade with targeted IL-15 pathway stimulation to expand/activate CD8+ T cells and NK cells, with mandatory repeat biopsies for biomarker studies.

ClinicalTrials.gov ID: NCT07133425

Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients With Metastatic 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: Adults with stage IV NSCLC without actionable driver mutations (ECOG 0–2) who develop oligoprogression (≤5 lesions, all safely treatable with SBRT/ablative RT) after ≥3 cycles of first-line immune checkpoint inhibitor–based therapy (ICI alone or ICI+chemotherapy; stable treated CNS metastases allowed). Compares SBRT/ablative radiotherapy to all progressing sites with continuation of current standard systemic management versus no RT and switching to standard approved second-line systemic therapy.

ClinicalTrials.gov ID: NCT06686771

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor 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: Adults with advanced/metastatic non-squamous NSCLC harboring sensitizing EGFR exon 19 deletion or L858R mutations with documented progression after a third-generation EGFR TKI regimen and eligible for platinum doublet chemotherapy. Patients are randomized to investigational izalontamab brengitecan (BMS-986507; targeted anticancer biologic with target/payload not publicly characterized, dose/schedule being optimized) versus cisplatin or carboplatin plus pemetrexed.

ClinicalTrials.gov ID: NCT07100080

A Phase 1/2 Study of REGN5093 in Patients With MET-Altered 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 unresectable/metastatic NSCLC harboring protocol-defined MET alterations (e.g., MET exon 14 skipping and/or MET amplification), ECOG 0–1, adequate organ function, and no untreated/active CNS disease are treated with REGN5093 (davutamig) monotherapy. REGN5093 is an investigational biparatopic/bispecific anti-MET monoclonal antibody that binds two MET epitopes to promote MET internalization/degradation and suppress MET-driven signaling, given in dose escalation followed by expansion at selected dose(s).

ClinicalTrials.gov ID: NCT04077099

Assessing the Impact of Circadian Rhythm on Anti-PD-1/PD-L1 Immunotherapy

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: Adults with advanced/metastatic cancers—especially first-line NSCLC (including maintenance after induction) and other solid tumors—who are receiving FDA on-label PD-1/PD-L1 immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab, atezolizumab, durvalumab; agents that block PD-1/PD-L1 signaling to restore T-cell antitumor activity) alone or with other approved therapies. Patients are randomized to receive each ICI dose on an early schedule (completed by 11:00 AM) versus a late schedule (start after 12:00 PM) to assess differences in outcomes and toxicity.

ClinicalTrials.gov ID: NCT07224971

A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction

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: Adults (≥18) with solid tumors and at least one intact/residual/recurrent “volatile” brain metastasis at higher risk for interval change/displacement (e.g., rapid growth, near edema or recent surgical cavity), KPS ≥60 and expected survival ≥3–6 months, are treated with same-day MRI-simulated, adaptively planned LINAC-based stereotactic radiosurgery/radiotherapy. Patients are randomized to stereotactic radiation using a 0 mm versus 1 mm planning target volume margin to test whether tighter margins can maintain control while reducing geographic miss and toxicity (e.g., radiation necrosis).

ClinicalTrials.gov ID: NCT07132190

A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer in Combination With Pembrolizumab as First-Line Treatment

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 previously untreated stage IV squamous or non-squamous NSCLC with PD-L1 TPS ≥50%, ECOG 0–1, measurable disease, and (for non-squamous) no actionable genomic alterations, excluding untreated CNS metastases and prior PD-(L)1 therapy. Treatment is petosemtamab (investigational EGFR×LGR5 bispecific antibody intended to inhibit tumor signaling and enhance immune-mediated activity) plus pembrolizumab (PD-1 inhibitor) as first-line therapy.

ClinicalTrials.gov ID: NCT07353957

A Phase I Clinical Trial of Carfilzomib in Combination With Sotorasib in Patients With KRASG12C Mutated Advanced 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.

TrialFetch AI summary: This trial evaluates the combination of carfilzomib, a proteasome inhibitor, and sotorasib, a KRAS G12C inhibitor, in adults with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer who have progressed after previous KRAS inhibitor treatments.

ClinicalTrials.gov ID: NCT06249282

Phase I Study of Gilteritinib for ALK Positive 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.

TrialFetch AI summary: The trial involves previously treated adult patients with stage IV ALK positive non-small cell lung cancer, evaluating the safety and optimal dosing of gilteritinib, an investigational drug that targets the FLT3 receptor tyrosine kinase. Patients must have progressed on first and second-generation ALK TKIs and may have had chemotherapy or other antineoplastic treatments.

ClinicalTrials.gov ID: NCT06225427

A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in 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.

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 targets adults with stage IV NSCLC involving liver metastases, excluding those with EGFR or BRAF mutations and prior liver radiation, to evaluate the impact of adding liver stereotactic ablative radiotherapy (L-SABR) to a standard regimen of anti-PD-(L)1 based immunotherapy and optional platinum-based chemotherapy.

ClinicalTrials.gov ID: NCT05657873