Clinical Trials for Non-Small Cell Lung Cancer

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

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: Enrolling adults with advanced, measurable NSCLC (ECOG 0–1) with RECIST-confirmed progression within 12 weeks on prior anti–PD-1/PD-L1–based therapy (first- or second-line), excluding EGFR/ALK-altered disease and patients with uncontrolled CNS metastases or significant autoimmune/pneumonitis history. Patients receive oral tulmimetostat (investigational dual EZH2/EZH1 inhibitor that reduces H3K27me3 to re-express silenced genes and potentially re-sensitize tumors to immunotherapy) with a 7-day run-in, combined with pembrolizumab 200 mg IV q3wk for up to 2 years.

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: Enrolling adults with advanced/metastatic nonsquamous NSCLC harboring KRAS G12C who have progressed after 1–2 prior lines including both PD-1/PD-L1 therapy and platinum chemotherapy, with no prior KRAS-targeted therapy and without active CNS disease or significant ILD/pneumonitis history. Patients are randomized to the investigational selective KRAS G12C-GDP covalent inhibitor MK-1084 combined with either patritumab deruxtecan (HER3-targeted topoisomerase I ADC), sacituzumab tirumotecan (TROP2-targeted topoisomerase I ADC), or cetuximab (EGFR monoclonal antibody).

ClinicalTrials.gov ID: NCT07286149

LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)

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 targets adult patients with non-small cell and small cell lung cancers experiencing oligo-progression while on stable systemic therapy, assessing the addition of locally ablative therapies like stereotactic ablative radiotherapy (SABR) and interventional radiology ablation for up to five or fewer metastatic lesions.

ClinicalTrials.gov ID: NCT06103682