Clinical Trials for Non-Small Cell Lung Cancer

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

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor 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 enrolls adults with advanced or metastatic EGFR-expressing solid tumors (including NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, or TNBC) who have progressed on or are intolerant to standard therapies, to receive JANX008—a protease-activated bispecific antibody that redirects T cells (via CD3) to target tumor cells (via EGFR), aiming to reduce off-tumor toxicity.

ClinicalTrials.gov ID: NCT05783622

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

A Platform Study of RAS(ON) Inhibitor Combinations in Patients With RAS-Mutated 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: This trial enrolls adults with advanced or metastatic RAS-mutated NSCLC (including KRAS G12C and G12D subtypes) who have progressed on standard therapies, testing investigational RAS(ON) inhibitors—RMC-6291 (KRAS G12C-selective), RMC-6236 (multi-selective RAS), and RMC-9805 (KRAS G12D-selective via cyclophilin A tri-complex)—alone or combined with pembrolizumab or platinum-based chemotherapies. Eligible patients must have ECOG 0–1 and adequate organ function.

ClinicalTrials.gov ID: NCT06162221

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients 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: This trial enrolls adults with advanced or metastatic solid tumors (including HNSCC, NSCLC, mCRC, and PDAC) who have progressed on or lack standard therapies, to evaluate [225Ac]-FPI-2068, an investigational targeted alpha-emitting radiopharmaceutical directed against EGFR and c-MET, with or without FPI-2053 (a bispecific EGFR/c-MET antibody), and includes [111In]-FPI-2107 for diagnostic imaging.

ClinicalTrials.gov ID: NCT06147037

An Open-Label Phase 1/2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and/or Refractory Solid Tumor 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 enrolls adults with advanced or refractory solid tumors—including specific cohorts for endometrial, head and neck squamous, melanoma, non-small cell lung, and pMMR/MSS colorectal cancers—who have failed standard therapies and have good performance status. Patients receive GV20-0251, a first-in-class anti-IGSF8 monoclonal antibody targeting a novel immune checkpoint, as monotherapy or combined with pembrolizumab.

ClinicalTrials.gov ID: NCT05669430