Clinical Trials for Non-Small Cell Lung Cancer

An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults 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.

TrialFetch AI summary: Adults with unresectable advanced/metastatic solid tumors (excluding HCC, sarcomas, gliomas) who have progressed on or are unsuitable for standard therapy receive PRTH-101, an anti‑DDR1 monoclonal antibody intended to disrupt collagen-mediated T‑cell exclusion, either as monotherapy or combined with pembrolizumab. Suitable for ECOG 0–1 with treated/stable CNS disease only; key exclusions include active autoimmune disease on immunosuppression, uncontrolled infections, and recent systemic therapy or radiation.

ClinicalTrials.gov ID: NCT05753722

A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced 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.

TrialFetch AI summary: Adults with advanced/metastatic NSCLC (squamous or non-squamous), including both first-line AGA-negative and previously treated patients (with genotype-specific prior therapy, e.g., post–third-gen EGFR TKI), receive the HER3-directed topoisomerase I ADC BNT326 combined with the PD-L1/VEGF-A bispecific antibody BNT327, with arms also testing each agent alone and standard-of-care comparators by PD-L1 status. Excludes prior HER3/topo I ADC exposure (with limited exceptions), uncontrolled ILD/pneumonitis, active CNS disease needing steroids/anticonvulsants, significant effusions, and high-grade prior irAEs leading to ICI discontinuation.

ClinicalTrials.gov ID: NCT07111520

A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With 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/metastatic NSCLC (ECOG 0–1), excluding EGFR/ALK alterations, receive intratumoral tolododekin alfa (ANK-101), an anchored IL‑12 designed for localized immune activation, combined with an anti–PD-1/PD-L1 antibody. Includes two cohorts: post–PD-1/PD-L1 and platinum–pretreated patients receiving tolododekin alfa plus cetrelimab, and treatment‑naïve patients receiving tolododekin alfa plus investigator’s choice of approved PD-1/PD-L1 inhibitor; mandatory fresh biopsies.

ClinicalTrials.gov ID: NCT07027514

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous 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: Enrolling adults with advanced/metastatic squamous malignancies (including squamous NSCLC and head and neck SCC) that have progressed after or are not candidates for standard therapies, with measurable disease; prior PD-1/PD-L1 therapy is allowed and tumor tissue/biopsies are required for biomarker analyses in some cohorts. Patients receive oral ABBV-711 (mechanism/target not publicly disclosed) as monotherapy or in combination with budigalimab (ABBV-181), an engineered anti–PD-1 IgG1 monoclonal antibody.

ClinicalTrials.gov ID: NCT07241039

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in 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.

TrialFetch AI summary: Adults with metastatic NSCLC harboring KRAS G12C (ECOG 0–1) who have progressed on or are intolerant to platinum chemotherapy and PD-(L)1 therapy (no prior KRAS inhibitor; no other actionable driver alterations; stable/asymptomatic treated brain metastases allowed). Patients receive IV amivantamab (EGFR/MET bispecific antibody) in combination with oral olomorasib/LY3537982 (selective KRAS G12C inhibitor binding the GDP-bound mutant) until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07227025

A Phase 2 Study of DRP-104, a Glutamine Antagonist, in Patients With NFE2L2/KEAP1-altered 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.

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: Enrolling adults with advanced/metastatic or unresectable NSCLC harboring NFE2L2 or KEAP1 alterations who have RECIST-measurable disease and have progressed after prior platinum-based chemotherapy and anti–PD-1/PD-L1 therapy (ECOG 0–1; stable treated brain metastases allowed). Patients receive single-agent DRP-104 (sirpiglenastat) subcutaneously twice weekly in continuous 21-day cycles; DRP-104 is a tumor-targeted prodrug of DON, a broad glutamine antagonist that irreversibly inhibits multiple glutamine-utilizing enzymes.

ClinicalTrials.gov ID: NCT07249372

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted 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 centrally confirmed MTAP homozygous loss/deletion and advanced solid tumors (ECOG 0–1) who have progressed after standard therapy are enrolled in dose escalation (mesothelioma, gastroesophageal, NSCLC, urothelial), with dose-expansion limited to MTAP-deleted NSCLC after platinum chemotherapy and PD-1/PD-L1 therapy (≤3 prior lines, prior appropriate targeted therapy if actionable). Participants receive IDE892, an MTA-cooperative PRMT5 inhibitor, as monotherapy or combined with IDE397, an oral MAT2A inhibitor, in 21-day cycles.

ClinicalTrials.gov ID: NCT07277413

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 locally advanced/metastatic solid tumors harboring KRAS/NRAS/HRAS mutations (ECOG 0–1, measurable disease) who have progressed on/intolerant to standard therapy are eligible for dose exploration, with expansions in previously untreated non-squamous NSCLC without another actionable driver and in solid tumors/CRC with ≤2 prior advanced lines (HNSCC excluded). Patients receive an oral RAS(ON) inhibitor—daraxonrasib (pan-RAS(ON)), elironrasib (KRAS G12C(ON)), or zoldonrasib (KRAS G12D(ON))—combined with ivonescimab (PD-1/VEGF bispecific antibody), with select cohorts adding platinum/pemetrexed chemotherapy, cetuximab, or additional RAS(ON) inhibitor.

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: Eligible patients are adults with locally advanced/metastatic KRAS G12V–mutant solid tumors (ECOG 0–1, measurable disease) that have progressed on or are intolerant to standard therapies. Treatment is oral RMC-5127, a KRAS G12V–selective RAS(ON) inhibitor (cyclophilin A–enabled tri-complex), given alone or combined with oral daraxonrasib (pan-RAS(ON) inhibitor) or with cetuximab.

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