Clinical Trials for Non-Small Cell Lung Cancer

A First-In-human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Administered by Parenteral Route in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3

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 advanced, DLL3-positive small cell lung cancer, large cell neuroendocrine lung carcinoma, or neuroendocrine carcinoma of any origin who have progressed after standard therapies, to receive BI 764532—a parenterally administered DLL3/CD3 bispecific T-cell engager antibody. Eligible patients must have good performance status and adequate organ function, and may include those with treated or stable brain metastases.

ClinicalTrials.gov ID: NCT04429087

A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

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 or metastatic non-small cell lung cancer harboring KRAS G12C mutations who have previously received platinum-based chemotherapy and immunotherapy, randomizing them to receive either 600 mg adagrasib twice daily (without regard to food) or 400 mg twice daily with food. Adagrasib is an investigational, selective KRAS G12C inhibitor that irreversibly inactivates mutant KRAS G12C.

ClinicalTrials.gov ID: NCT05853575

A Phase Ib Study of AZD9291 (Osimertinib) and BC2059 (Tegavivint) As First-Line Therapy in Patients with Metastatic EGFR-Mutant 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.

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 treatment-naïve, metastatic EGFR-mutant NSCLC (exon 19 deletion, L858R, or select uncommon mutations) to receive osimertinib plus tegavivint, a TBL1 inhibitor that disrupts Wnt/β-catenin signaling, as first-line therapy. Patients must have an ECOG PS 0–2 and may have asymptomatic, treated brain metastases.

ClinicalTrials.gov ID: NCT04780568

A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant 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.

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 advanced solid tumors harboring a KRAS G12C mutation, including both previously treated and some untreated NSCLC and CRC patients, to evaluate the oral KRAS G12C inhibitor LY3537982 (olomorasib) as monotherapy or in combination with pembrolizumab, cetuximab, pemetrexed, cisplatin, or carboplatin.

ClinicalTrials.gov ID: NCT04956640

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

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 stage IV or recurrent non-squamous NSCLC, PD-L1 ≥1%, no actionable driver mutations, and good performance status, comparing first-line nivolumab (PD-1 inhibitor) plus relatlimab (LAG-3 inhibitor) with chemotherapy versus pembrolizumab plus chemotherapy. Prior checkpoint inhibitor therapy, untreated CNS metastases, and active autoimmune diseases are exclusion criteria.

ClinicalTrials.gov ID: NCT06561386

Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic 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.

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 advanced or metastatic squamous or non-squamous NSCLC (excluding tumors with actionable genomic alterations), either CPI-experienced or treatment-naive with documented PD-L1 expression, to receive rilvegostomig (AZD2936), an intravenous bispecific anti-TIGIT/anti-PD-1 antibody designed to enhance T-cell antitumor activity. Patients must have ECOG 0-1 and adequate organ function.

ClinicalTrials.gov ID: NCT04995523

Phase I Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-Small Cell Lung Cancer

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, unresectable NSCLC and PD-L1 expression whose disease has progressed after standard therapy, including those with stable or treated brain metastases. Participants receive pembrolizumab (anti–PD-1 immune checkpoint inhibitor) plus aerosolized aztreonam and vancomycin, which are being used to modulate the lung microbiome and potentially enhance immunotherapy response.

ClinicalTrials.gov ID: NCT05777603

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

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: Adult patients with unresectable locally advanced or metastatic solid tumors (including melanoma, renal cell carcinoma, or PD-L1-positive NSCLC) who have progressed after or are ineligible for standard therapies receive AU-007, a novel monoclonal antibody that redirects IL-2 activity toward effector T and NK cells by blocking IL-2Rα, as monotherapy or in combination with recombinant IL-2 and/or checkpoint inhibitors. Patients must have adequate organ function, resolved prior immunotherapy toxicity, and measurable or evaluable disease.

ClinicalTrials.gov ID: NCT05267626

A Phase 1/2 Study of Combination Lorlatinib and Ramucirumab in Patients With Advanced ALK-rearranged Lung Cancers

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 metastatic or recurrent ALK fusion-positive NSCLC, including both those who are treatment-naïve and those previously treated with at least one second-generation ALK TKI, and evaluates the combination of lorlatinib (a third-generation ALK/ROS1 tyrosine kinase inhibitor with CNS activity) and ramucirumab (a VEGFR2 inhibitor targeting angiogenesis).

ClinicalTrials.gov ID: NCT06007937

A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

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 relapsed or metastatic solid tumors—particularly breast, ovarian, endometrial, biliary tract, and squamous NSCLC—who have received prior therapy, evaluating the antibody-drug conjugate AZD8205 (targets B7-H4 and delivers a topoisomerase I inhibitor) as monotherapy or in combination with the PD-1/TIGIT bispecific antibody rilvegostomig or the PARP inhibitor saruparib. Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function, with some sub-studies focusing on select tumor types.

ClinicalTrials.gov ID: NCT05123482