Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced 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: Adults with advanced or metastatic non-small-cell lung, gastroesophageal, colorectal, hepatocellular, pancreatic, or head and neck squamous cell cancer that has progressed on standard therapy, or who cannot tolerate it, receive intravenous DM005 monotherapy every 21 days. DM005 is an investigational bispecific antibody–drug conjugate targeting EGFR and MET that delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06515990

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With 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: Adults with ECOG 0–1 and advanced or metastatic RAS-mutant solid tumors are eligible; expansion cohorts include untreated nonsquamous NSCLC and previously treated solid tumors or colorectal cancer. Treatment pairs ivonescimab (PD-1/VEGF-A bispecific antibody) with a RAS(ON) inhibitor—daraxonrasib (multiple RAS variants), elironrasib (KRAS G12C), or zoldonrasib (KRAS G12D)—with selected cohorts adding platinum–pemetrexed, daraxonrasib, or cetuximab.

ClinicalTrials.gov ID: NCT07397338

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant 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: Adults with measurable, advanced KRAS G12V-mutant solid tumors after progression on or intolerance to standard therapy receive RMC-5127 alone or with daraxonrasib or cetuximab; prior direct RAS-targeted therapy is excluded. RMC-5127 is an investigational inhibitor of active KRAS G12V, daraxonrasib inhibits active RAS across multiple variants, and cetuximab targets EGFR.

ClinicalTrials.gov ID: NCT07349537

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with previously untreated metastatic or unresectable stage IIIC/IV NSCLC (ECOG 0–2) eligible for first-line immune checkpoint inhibitor–based therapy, excluding tumors with actionable driver alterations (e.g., EGFR/ALK/ROS1/RET/NTRK/METex14/HER2). Patients are randomized to treatment selection guided by the PROphet Clinical Benefit blood-based proteomic assay plus CARG toxicity risk tool versus standard biomarker/clinical selection, choosing among standard PD-(L)1 antibody regimens with or without platinum chemotherapy and/or CTLA-4 blockade.

ClinicalTrials.gov ID: NCT07250477

Phase Ib/II Study of Safety and Efficacy of EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of 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.

TrialFetch AI summary: Adults with advanced NSCLC that has progressed after first- or second-line immunotherapy, including anti-PD-1/PD-L1 therapy, receive oral tulmimetostat, an investigational EZH2/EZH1 inhibitor, plus pembrolizumab (PD-1 blockade). Patients with EGFR or ALK alterations or active brain metastases are excluded.

ClinicalTrials.gov ID: NCT05467748

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

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: Adults with advanced or metastatic KRAS G12C-mutated nonsquamous NSCLC that has progressed after 1–2 prior lines including platinum chemotherapy and PD-1/PD-L1 therapy, and who have not received prior KRAS-targeted therapy, receive calderasib, a KRAS G12C inhibitor, combined with either patritumab deruxtecan (HER3-directed ADC), sacituzumab tirumotecan (TROP2-directed ADC), or cetuximab (EGFR-directed antibody).

ClinicalTrials.gov ID: NCT07286149

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types

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: Open-label multicohort study for patients with CLDN18.2-expressing unresectable locally advanced or metastatic gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, or selected other solid tumors after at least one prior systemic therapy and ECOG 0–1. Participants receive IV ASP546C every 3 weeks, a CLDN18.2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor payload, with dose evaluation in gastroesophageal cancer and higher-dose cohorts in pancreatic and pan-tumor populations.

ClinicalTrials.gov ID: NCT07488676

A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours

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: Adults with ECOG 0–1 and advanced/metastatic unresectable solid tumors in selected cohorts: mesothelioma, metastatic pancreatic ductal adenocarcinoma, or KRAS G12C-mutated NSCLC. All receive investigational oral ODM-212, a pan-TEAD/Hippo pathway inhibitor targeting YAP/TAZ–TEAD signaling, combined respectively with ipilimumab/nivolumab, gemcitabine/nab-paclitaxel, or sotorasib.

ClinicalTrials.gov ID: NCT07563738

AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED 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: Adults with previously untreated, unresectable stage IIIB/IIIC or metastatic NSCLC and no known actionable genomic alterations receive PF-08634404, an investigational PD-1/VEGF bispecific antibody, plus either sigvotatug vedotin, an integrin β6–targeted MMAE antibody–drug conjugate, or another protocol-specified anticancer agent. The latter cohort requires PD-L1 TPS ≥1%.

ClinicalTrials.gov ID: NCT07227298

A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy

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: Adults with metastatic NSCLC harboring an osimertinib-sensitive EGFR mutation who have progressed after a third-generation EGFR TKI and received platinum chemotherapy or are ineligible for it receive ivonescimab, a PD-1/VEGF-A bispecific antibody, plus either datopotamab deruxtecan, a TROP2-directed topoisomerase I inhibitor antibody–drug conjugate, or osimertinib.

ClinicalTrials.gov ID: NCT07535437