Clinical Trials for Non-Small Cell Lung Cancer

Phase II Trial of LP-300 in Combination with Carboplatin and Pemetrexed in Never Smoker Patients with Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment with Tyrosine Kinase Inhibitors (The HARMONIC Study)

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

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: Adults with inoperable stage III/IV lung adenocarcinoma and an actionable genomic alteration who have progressed on or cannot continue a TKI—primarily never-smokers—receive carboplatin and pemetrexed with or without LP-300 (dimesna). LP-300 is an investigational disulfide proposed to modify platinum-related toxicity and enhance anticancer activity; its clinically relevant mechanism remains uncertain.

ClinicalTrials.gov ID: NCT05456256

A Phase II, Multisite, Open-label, Single Arm Trial of BNT327 in Combination With Docetaxel in Second-line Stage IV Non-small Cell Lung Cancer (NSCLC) Following Chemoimmunotherapy

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 NSCLC that progressed after one platinum-based chemoimmunotherapy regimen receive docetaxel plus investigational BNT327 (pumitamig), a bispecific antibody targeting PD-L1 and VEGF-A. Eligible patients must have ECOG performance status 0–1 and no prior docetaxel or anti-VEGF antibody treatment.

ClinicalTrials.gov ID: NCT06841055

A Phase 2 Study of Defactinib and Avutometinib, in Combination With Nivolumab for Patients With Anti-PD1 Refractory LKB1-Mutant Advanced Lung Adenocarcinoma

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, LKB1-mutant advanced lung adenocarcinoma that has progressed after checkpoint inhibition and first-line chemotherapy receive defactinib (FAK/PYK2 inhibitor), avutometinib (RAF–MEK pathway inhibitor), and nivolumab (anti-PD-1). One cohort also requires a KRAS mutation.

ClinicalTrials.gov ID: NCT06495125

A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

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

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: Adults with locally advanced or metastatic NSCLC harboring EGFR L861Q, G719X, and/or S768I mutations, ECOG 0–2, no prior EGFR inhibitor, and at most one prior chemotherapy line receive oral sutetinib maleate monotherapy. Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor; this single-arm study has no comparator.

ClinicalTrials.gov ID: NCT05168566

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.

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

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: Adults with locally advanced or metastatic EGFR-mutated NSCLC are enrolled across cohorts with exon 20 insertions or other uncommon EGFR mutations, including patients with active brain metastases or leptomeningeal disease. All receive oral zipalertinib, an investigational irreversible EGFR tyrosine kinase inhibitor designed to target these mutations while relatively sparing wild-type EGFR.

ClinicalTrials.gov ID: NCT05967689

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

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

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: Adults with previously untreated, unresectable stage IIIB/IIIC or stage IV nonsquamous NSCLC, PD-L1 TPS ≥50%, and no actionable genomic alterations are randomized to pembrolizumab plus datopotamab deruxtecan or pembrolizumab alone. Datopotamab deruxtecan is a TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT05215340

A Phase 2 Trial of SX-682 and Pembrolizumab in Patients With Treatment Naive Stage IV or Recurrent 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

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: Adults with treatment-naive metastatic or recurrent NSCLC, or unresectable stage IIIC disease not amenable to curative radiation, are eligible if PD-L1 expression is ≥1%, ECOG performance status is 0–1, and there is no known EGFR, ALK, ROS1, or RET alteration. All participants receive pembrolizumab plus oral SX-682, a CXCR1/2 inhibitor intended to reduce recruitment of immunosuppressive myeloid cells.

ClinicalTrials.gov ID: NCT05570825

A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 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.

TrialFetch AI summary: Adults with untreated stage IV squamous or nonsquamous NSCLC, ECOG 0–1, and no alteration warranting approved first-line targeted therapy receive investigational EIK1001, a TLR7/8 agonist, plus pembrolizumab and carboplatin with paclitaxel (squamous) or pemetrexed (nonsquamous). The study has no standard-of-care-only control arm.

ClinicalTrials.gov ID: NCT06246110

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

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

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: Adults with metastatic squamous NSCLC who have progressed after platinum chemotherapy and at least 12 weeks of PD-1/PD-L1–based therapy are randomized to gotistobart or docetaxel. Gotistobart is an investigational anti-CTLA-4 antibody designed to enhance tumor regulatory T-cell depletion.

ClinicalTrials.gov ID: NCT05671510

A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous 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 previously untreated metastatic nonsquamous NSCLC and no actionable genomic alteration receive platinum–pemetrexed chemotherapy followed by pemetrexed maintenance, combined with investigational livmoniplimab (which inhibits activation of TGF-β1) plus budigalimab (anti–PD-1), budigalimab alone in dose selection, or pembrolizumab (anti–PD-1).

ClinicalTrials.gov ID: NCT06236438