Clinical Trials for Non-Small Cell Lung Cancer

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 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: This trial compares the combination of pembrolizumab and valemetostat tosylate, a dual EZH1/2 inhibitor, with pembrolizumab alone in patients with advanced or metastatic non-small cell lung cancer expressing PD-L1 ≥50% and lacking actionable genomic alterations. It includes patients who have not received prior systemic therapy and have a performance status of 0 or 1.

ClinicalTrials.gov ID: NCT06644768

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: This trial enrolls patients with unresectable or metastatic melanoma (including those previously treated with PD-1 inhibitors or BRAF-targeted therapies), advanced head and neck squamous cell carcinoma, or locally advanced/metastatic non-small cell lung cancer, providing treatment with autologous tumor-infiltrating lymphocyte (TIL) products—lifileucel (LN-144/LN-145) or next-generation PD-1-selected LN-145-S1—either as monotherapy or in combination with immune checkpoint inhibitors (ICIs). Eligibility requires at least one resectable lesion and ECOG 0-1, and excludes active autoimmune disease or untreated symptomatic brain metastases.

ClinicalTrials.gov ID: NCT03645928

A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic 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.

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: This trial enrolls adults with metastatic, EGFR/ALK/ROS1-negative NSCLC who have progressed after prior immune checkpoint inhibitor and platinum chemotherapy, and who have a resectable tumor lesion and good performance status. Patients receive LN-145, an autologous tumor-infiltrating lymphocyte (TIL) therapy that reinfuses expanded tumor-reactive T cells following lymphodepleting chemotherapy, aiming to stimulate anti-tumor immunity.

ClinicalTrials.gov ID: NCT04614103

A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

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: This trial enrolls adults with advanced NSCLC harboring EGFR mutations—including exon 20 insertions, classical (Ex19del, L858R), uncommon, or T790M drug-resistant mutations—to receive oral PLB1004, a novel irreversible EGFR tyrosine kinase inhibitor designed for broad activity across EGFR mutations with selectivity over wild-type EGFR.

ClinicalTrials.gov ID: NCT06046495

Safety and Efficacy of Ivonescimab and Chemotherapy Plus Stereotactic Radiosurgery (SRS) in the Treatment of Non-Small Cell Lung Cancer Brain Metastases

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 ECOG 0–1 squamous or non-squamous NSCLC and 1–3.5 cm brain metastases suitable for SRS receive investigational ivonescimab, a bispecific PD-1/VEGF antibody, with platinum-based chemotherapy followed by fractionated SRS. This single-arm study includes dose finding then expansion to assess safety and preliminary intracranial efficacy.

ClinicalTrials.gov ID: NCT07535463

A Pilot Study of Tepotinib + Ivonescimab in Patients With Advanced METex14 Skipping Positive NSCLC

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 measurable advanced or recurrent MET exon 14 skipping–positive NSCLC, ECOG 0–2, and no other actionable driver receive tepotinib, a selective MET tyrosine kinase inhibitor, plus ivonescimab, a bispecific PD-1/VEGF antibody. Prior MET inhibitor and checkpoint inhibitor therapy are permitted, but prior antiangiogenic therapy is excluded.

ClinicalTrials.gov ID: NCT07619339

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced 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.

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 evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other 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 involves patients with metastatic or unresectable non-small cell lung cancer and other solid tumors who receive BL-B01D1, a bispecific antibody-drug conjugate targeting EGFR and HER3, designed with a novel topoisomerase I inhibitor payload. The study evaluates different dosing schedules to determine safety, tolerability, and efficacy, particularly aiming to optimize dosing based on promising response rates in EGFR-mutated NSCLC and other cancer types.

ClinicalTrials.gov ID: NCT05983432