Clinical Trials for Non-Small Cell Lung Cancer

Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult 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 solid tumors and specified RAS alterations (or HRAS-overexpressing head and neck squamous cell carcinoma) receive darlifarnib, an investigational farnesyltransferase inhibitor, alone. Combination cohorts pair darlifarnib with cabozantinib for renal cell carcinoma previously treated with immunotherapy or with adagrasib for previously treated KRAS G12C-mutant lung, colorectal, or pancreatic cancer.

ClinicalTrials.gov ID: NCT06026410

A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation

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 treated advanced pancreatic ductal adenocarcinoma or NSCLC harboring MTAP loss and a RAS mutation receive oral vopimetostat (TNG462), an MTAP-selective PRMT5 inhibitor, plus either daraxonrasib (RMC-6236), a multi-variant RAS inhibitor, or zoldonrasib (RMC-9805), a KRAS G12D inhibitor. Prior RAS-targeted therapy, PRMT5 inhibitors, or MAT2A inhibitors are excluded.

ClinicalTrials.gov ID: NCT06922591

A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or 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: For adults with previously untreated stage IV squamous or nonsquamous NSCLC, PD-L1 TPS ≥1%, and no actionable alteration with approved first-line targeted therapy, this study evaluates rilvegostomig, an investigational PD-1/TIGIT bispecific antibody, combined with either AB248, a CD8-targeted IL-2 fusion protein, or platinum-based chemotherapy. Chemotherapy combinations include ramucirumab (anti-VEGFR2) in the squamous expansion cohort and are tested with or without it in nonsquamous disease.

ClinicalTrials.gov ID: NCT06996782

A Phase 1/2, Open-label, Multicenter Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of S095035 (MAT2A Inhibitor) as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP

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 MTAP-homozygously deleted solid tumors that have progressed after prior treatment and have no effective standard therapy receive oral S095035, a MAT2A inhibitor, alone or with TNG462, a PRMT5 inhibitor. Eligible tumors include NSCLC, biliary tract, pancreatic, gastroesophageal, and IDH-wild-type glioblastoma.

ClinicalTrials.gov ID: NCT06188702

A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated 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 treated, unresectable or metastatic KRAS G12D-mutated solid tumors receive oral VS-7375, an investigational inhibitor of active and inactive KRAS G12D, alone or with the anti-EGFR antibody cetuximab. Expansion cohorts focus on pancreatic cancer and NSCLC for monotherapy and colorectal cancer for the combination; prior direct KRAS G12D inhibitor treatment is excluded.

ClinicalTrials.gov ID: NCT07020221

A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced 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 unresectable advanced or metastatic NSCLC or SCLC, including first-line and previously treated cohorts, receive BNT324 (DB-1311), a B7-H3–targeted antibody–drug conjugate carrying a topoisomerase I inhibitor, plus BNT327 (pumitamig), a PD-L1/VEGF-A bispecific antibody. The study evaluates combination dosing, safety, and preliminary antitumor activity without a standard-of-care comparator.

ClinicalTrials.gov ID: NCT06892548

Phase II Study of Diclofenac Salvage in Patients Metastatic Non-Small Cell Lung Cancer With Early Signs of Progression on Single Agent PD(L)-1 Blockade

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: Enrolling adults with stage III or IV metastatic non-small cell lung cancer who are experiencing early radiographic progression on at least 12 weeks of single-agent PD-1 or PD-L1 inhibitor immunotherapy, this trial adds diclofenac (a cyclooxygenase-inhibiting NSAID with potential immunomodulatory effects) to ongoing checkpoint inhibitor therapy. Patients must have adequate organ function, ECOG 0-2, and no contraindications to NSAIDs or need for anticoagulation.

ClinicalTrials.gov ID: NCT06731270

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies 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 measurable advanced or recurrent solid tumors, including previously treated melanoma, NSCLC, and HER2-negative breast cancer, receive BNT326 (beruzatatug pelitecan), a HER3-directed antibody–drug conjugate carrying a topoisomerase-I inhibitor. Melanoma and HER2-negative breast cancer cohorts also evaluate BNT326 with BNT327 (pumitamig), a PD-L1/VEGF-A bispecific antibody.

ClinicalTrials.gov ID: NCT07070232

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1)

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 EGFR exon 19 deletion– and/or L858R-mutated NSCLC that has progressed on or is intolerant to at least one EGFR TKI receive oral DZD6008, an investigational fourth-generation EGFR TKI targeting activating and C797X resistance mutations. Dose expansion is limited to patients with an EGFR C797X mutation.

ClinicalTrials.gov ID: NCT06905197

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

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 metastatic or otherwise incurable NSCLC, PD-L1 expression ≥1%, and ECOG performance status 0–2 receive intravenous trabedersen plus pembrolizumab. Trabedersen is an investigational antisense oligonucleotide targeting TGF-β2 mRNA; pembrolizumab inhibits PD-1.

ClinicalTrials.gov ID: NCT06579196