Clinical Trials for Non-Small Cell Lung Cancer

A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3)

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

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: Adults with previously untreated stage IV squamous or nonsquamous NSCLC, ECOG 0–1, and no actionable alterations with approved first-line therapies are randomized to chemotherapy plus either ivonescimab or pembrolizumab. Ivonescimab is an investigational bispecific antibody targeting PD-1 and VEGF-A.

ClinicalTrials.gov ID: NCT05899608

A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)

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

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 trial enrolls patients with locally advanced or metastatic NSCLC harboring uncommon EGFR PACC mutations who have received no systemic therapy for advanced disease; asymptomatic CNS metastases are permitted. Patients receive first-line firmonertinib, an irreversible EGFR tyrosine kinase inhibitor, or investigator-selected osimertinib or afatinib.

ClinicalTrials.gov ID: NCT07185997

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

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.

TrialFetch AI summary: Adults with advanced, refractory solid tumors and ECOG performance status 0–1 receive intravenous IBI363 every 2 or 3 weeks. IBI363 is an investigational PD-1/IL-2α-biased fusion protein designed to combine PD-1 blockade with IL-2 signaling directed preferentially toward PD-1-positive T cells.

ClinicalTrials.gov ID: NCT06281678

A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

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.

TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced or metastatic ALK-rearranged NSCLC are randomized to oral neladalkib (NVL-655) or alectinib. Neladalkib is an investigational ALK tyrosine kinase inhibitor designed for CNS penetration and activity against ALK resistance mutations.

ClinicalTrials.gov ID: NCT06765109

RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] 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

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 unresectable locally advanced or metastatic NSCLC harboring a KRAS, NRAS, or HRAS codon 12, 13, or 61 mutation, previously treated with platinum chemotherapy and anti-PD-(L)1 therapy, are randomized to oral daraxonrasib or docetaxel. Daraxonrasib is a RAS(ON) inhibitor that targets active, GTP-bound RAS to block downstream signaling.

ClinicalTrials.gov ID: NCT06881784

An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced 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

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 previously treated unresectable stage IIIB/IIIC or metastatic NSCLC receive intravenous HLX43 every three weeks at one of two dose levels, with no standard-treatment control arm. HLX43 is an investigational PD-L1–directed antibody–drug conjugate carrying a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06907615

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

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.

TrialFetch AI summary: For patients with untreated metastatic non-squamous NSCLC, PD-L1 expression ≥1%, and no actionable driver with an approved first-line targeted therapy, this trial compares rilvegostomig plus platinum–pemetrexed chemotherapy with pembrolizumab plus the same chemotherapy. Rilvegostomig is an investigational bispecific antibody targeting PD-1 and TIGIT; both groups continue their assigned immunotherapy with pemetrexed maintenance.

ClinicalTrials.gov ID: NCT06627647

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS ≥50%

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.

TrialFetch AI summary: For patients with previously untreated, metastatic KRAS G12C-mutant NSCLC, PD-L1 TPS ≥50%, and ECOG performance status 0–1, this trial compares first-line pembrolizumab plus oral calderasib (MK-1084) with pembrolizumab plus placebo. Calderasib is an investigational covalent inhibitor of GDP-bound KRAS G12C.

ClinicalTrials.gov ID: NCT06345729

A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10).

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.

TrialFetch AI summary: Adults with previously untreated, unresectable stage IIIB/IIIC or metastatic non-squamous NSCLC, PD-L1 expression ≥50%, no actionable genomic alteration, and ECOG 0–1 are randomized to datopotamab deruxtecan plus rilvegostomig, rilvegostomig alone, or pembrolizumab alone. Datopotamab deruxtecan is a TROP2-directed antibody–drug conjugate carrying a topoisomerase I inhibitor; rilvegostomig is a bispecific PD-1/TIGIT antibody.

ClinicalTrials.gov ID: NCT06357533

A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)

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.

TrialFetch AI summary: Adults with locally advanced or metastatic NSCLC harboring uncommon EGFR mutations receive oral sutetinib maleate, an investigational irreversible EGFR tyrosine kinase inhibitor, in a single-arm study. Eligibility includes ECOG performance status 0–2; prior EGFR-TKI restrictions vary by cohort.

ClinicalTrials.gov ID: NCT06010329