Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies

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: This trial involves adult patients with advanced solid tumors, including those with platinum-resistant ovarian cancer or cutaneous squamous cell carcinoma, assessing the safety and efficacy of OR502, a monoclonal antibody targeting LILRB2 on tumor-associated macrophages, alone and with cemiplimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT06090266

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant 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: This trial involves patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations and evaluates the safety and efficacy of ORIC-114, a selective irreversible inhibitor targeting EGFR exon 20 mutations, in combination with amivantamab, a bispecific EGFR and MET receptor-directed antibody.

ClinicalTrials.gov ID: NCT06816992

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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 enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol)

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 advanced or metastatic gastric/GEJ adenocarcinoma, NSCLC, or pancreatic ductal adenocarcinoma expressing CEACAM5, who have progressed after 1–3 prior systemic therapies. The trial investigates M9140, an antibody-drug conjugate targeting CEACAM5 and delivering a topoisomerase I inhibitor payload, as monotherapy in these populations.

ClinicalTrials.gov ID: NCT06710132

A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in 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: This trial enrolls adults with advanced or metastatic solid tumors, including those with lesions amenable to intratumoral injection, to receive intratumoral tolododekin alfa (ANK-101), an anchored IL-12 conjugate that locally activates antitumor immunity, as monotherapy or in combination with cemiplimab for high-risk cutaneous squamous cell carcinoma. Patients must have progressed on or be ineligible for standard therapies.

ClinicalTrials.gov ID: NCT06171750

Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With NSCLC

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: This study enrolls Black/African American adults with advanced or metastatic NSCLC (EGFR/ALK/ROS1 wild-type), who are treatment-naïve in this setting, to receive standard-of-care pembrolizumab (an anti–PD-1 checkpoint inhibitor) alone or with chemotherapy. All interventions are FDA-approved, and cohort assignment is based on biomarkers such as PD-L1 and ctDNA levels.

ClinicalTrials.gov ID: NCT06745882

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

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: This trial enrolls adults with advanced or metastatic non-squamous NSCLC who are treatment-naïve for advanced disease and lack actionable genomic alterations, testing the combination of telisotuzumab adizutecan (an anti-c-Met antibody-drug conjugate with a topoisomerase I inhibitor payload) and the PD-1 inhibitor budigalimab versus standard of care regimens. Patients with uncontrolled CNS metastases or significant interstitial lung disease are excluded.

ClinicalTrials.gov ID: NCT06772623

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

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: This trial enrolls adults with metastatic or locally advanced thoracic tumors, including NSCLC, that have homozygous MTAP-deletion, and evaluates the safety and preliminary efficacy of AMG 193, an oral MTA-cooperative PRMT5 inhibitor targeting MTAP-deleted cells, as monotherapy or in combination with standard chemotherapies, immunotherapy, or sotorasib for KRAS G12C-mutated cases. Key subpopulations include those with specific NSCLC subtypes, KRAS G12C mutations, or active brain metastases.

ClinicalTrials.gov ID: NCT06333951

Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination with Low Dose Radiotherapy in Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer or Solid Tumors with Bone Metastases

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: This trial enrolls adults with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases who have progressed after standard therapies, to receive allogeneic gamma delta T-cell infusions (KB-GDT-01, an off-the-shelf cell therapy leveraging innate anti-tumor immune activity) in combination with fractionated low-dose radiotherapy. Patients must have ECOG 0-1 and all disease sites must be amenable to radiotherapy.

ClinicalTrials.gov ID: NCT06069570

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-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: This trial enrolls adults with advanced, previously treated KRAS G12D-mutant solid tumors (excluding those with CNS involvement or prior direct RAS inhibitor use) to receive the selective KRAS G12D inhibitor RMC-9805, either as monotherapy or combined with the RAS(ON) multi-selective inhibitor RMC-6236. RMC-9805 acts as a molecular glue inducing covalent modification of KRAS G12D, while RMC-6236 targets multiple active KRAS G12X mutations.

ClinicalTrials.gov ID: NCT06040541