Clinical Trials for Non-Small Cell Lung Cancer

An Open-Label Phase II Study of ILKN421H in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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.

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 ECOG 0–1, unresectable locally advanced or metastatic squamous or nonsquamous NSCLC without actionable EGFR/ALK/ROS1 alterations are eligible either after progression on PD-1/PD-L1 therapy regardless of PD-L1 status or untreated with PD-L1 TPS ≥1%. Patients receive pembrolizumab plus ILKN421H, an mRNA therapy encoding an albumin-fused, IL-2Rβ/γ-selective IL-2 variant designed to expand CD8 T and NK cells while avoiding IL-2Rα signaling.

ClinicalTrials.gov ID: NCT07452224

A Phase II Study of Ivonescimab as Monotherapy or in Combination With Platinum/Pemetrexed Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring Actionable Genomic Alterations (AGAs)

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.

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 nonsquamous NSCLC harboring an EGFR sensitizing mutation or ALK, ROS1, RET, or NTRK fusion receive ivonescimab after genotype-appropriate targeted therapy and platinum/pemetrexed. A separate chemotherapy-naive cohort without EGFR-mutated disease receives ivonescimab plus carboplatin/pemetrexed after targeted therapy; ivonescimab is an investigational bispecific antibody targeting PD-1 and VEGF-A.

ClinicalTrials.gov ID: NCT07405190

A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment

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.

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 stage IV non-squamous NSCLC, ECOG 0–1, progressing after ≥12 weeks of pembrolizumab-based therapy and prior platinum chemotherapy, with an injectable thoracic lesion, are randomized to continued pembrolizumab plus intratumoral CAN-2409 and oral valacyclovir or docetaxel. CAN-2409 is a nonreplicating adenoviral vector encoding HSV thymidine kinase that activates valacyclovir metabolites to induce tumor-cell death and systemic antitumor immunity.

ClinicalTrials.gov ID: NCT07660094

A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum Based Chemotherapy and Checkpoint Inhibitor Therapy (CPI)

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.

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 locally advanced or metastatic KRAS G12D-mutated NSCLC, ECOG 0–1, who progressed after platinum chemotherapy and anti–PD-1/PD-L1 therapy are randomized to IV setidegrasib or docetaxel. Setidegrasib is a KRAS G12D-selective protein degrader that recruits VHL E3 ligase to drive mutant KRAS degradation.

ClinicalTrials.gov ID: NCT07566052

A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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.

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 untreated stage IV or recurrent unresectable NSCLC, ECOG 0–1, and no actionable alteration warranting approved first-line targeted therapy are randomized to pumitamig plus histology-directed platinum-doublet chemotherapy with or without imzokitug. Pumitamig targets PD-L1 and VEGF-A; imzokitug targets CCR8 to deplete tumor-infiltrating regulatory T cells.

ClinicalTrials.gov ID: NCT07680764

A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients With Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)

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.

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: Patients with unresectable locally advanced or metastatic KRAS G12D-mutated NSCLC that has progressed after platinum chemotherapy and immune checkpoint inhibition receive daily oral VS-7375 monotherapy, an investigational inhibitor of both the active and inactive states of KRAS G12D. A dedicated cohort includes patients with untreated, asymptomatic brain metastases.

ClinicalTrials.gov ID: NCT07659782

A Phase 2 Trial of SX-682 and Atezolizumab in Patients With Advanced NSCLC Who Progressed on Prior Chemotherapy and Immune Checkpoint Inhibitor (ICI) Therapy

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.

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, recurrent, or unresectable stage IIIC NSCLC who progressed after platinum-doublet chemotherapy and anti–PD-1/PD-L1 therapy receive oral SX-682, an investigational CXCR1/2 inhibitor, plus subcutaneous atezolizumab, an anti–PD-L1 antibody. Patients with known EGFR mutations or ALK, ROS1, or RET fusions are excluded.

ClinicalTrials.gov ID: NCT07322341

A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial Of Valemetostat Tosylate Plus Pembrolizumab Vs Pembrolizumab Alone in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 With Tumor Proportion Score ≥50% Without Actionable Genomic Alterations

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.

TrialFetch AI summary: For adults with previously untreated, unresectable stage IIIB/IIIC or stage IV NSCLC, PD-L1 TPS ≥50%, and no actionable genomic alterations, this study compares first-line pembrolizumab plus oral valemetostat with pembrolizumab alone. Valemetostat inhibits EZH1 and EZH2, enzymes involved in repressive histone methylation.

ClinicalTrials.gov ID: NCT06644768

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

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.

TrialFetch AI summary: Adults with recurrent IDH-mutant astrocytoma or IDH-wildtype glioblastoma after radiation-based treatment receive oral NEO212 alone; patients with selected solid tumors and brain metastases uncontrolled by surgery or radiation receive it with tumor-appropriate standard-of-care therapy. NEO212 is an investigational temozolomide–perillyl alcohol conjugate that acts as a DNA-alkylating agent.

ClinicalTrials.gov ID: NCT06047379

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

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.

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.

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: Patients with unresectable or metastatic melanoma, recurrent or metastatic head and neck squamous cell carcinoma, or stage III–IV non-small cell lung cancer receive autologous tumor-infiltrating lymphocytes (lifileucel/LN-144, LN-145, or PD-1-selected LN-145-S1) after lymphodepleting chemotherapy, followed by aldesleukin. Depending on the cohort, treatment is given alone or with checkpoint inhibitors; some frontline lung cancer cohorts also receive platinum-doublet chemotherapy plus pembrolizumab.

ClinicalTrials.gov ID: NCT03645928