Clinical Trials for Non-Small Cell Lung Cancer

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: Adults with metastatic EGFR exon 19 deletion– or L858R-mutant NSCLC who have not received an EGFR tyrosine kinase inhibitor receive first-line osimertinib plus investigational tegavivint, followed by osimertinib alone. Tegavivint inhibits Wnt/β-catenin signaling by binding TBL1 proteins.

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 patients with unresectable or metastatic KRAS G12C-mutant solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer, generally after standard therapy; a cohort includes previously untreated advanced NSCLC. Patients receive olomorasib, an oral inhibitor that binds inactive KRAS G12C, alone or with pembrolizumab, cetuximab, or pembrolizumab plus pemetrexed and platinum chemotherapy, depending on cohort.

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 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: This trial enrolls patients with unresectable locally advanced or metastatic solid tumors who have exhausted, cannot tolerate, or are ineligible for standard therapy, with expansion cohorts focused on melanoma, renal cell carcinoma, and selected NSCLC. Patients receive imneskibart (AU-007), an anti-IL-2 antibody that blocks IL-2 binding to CD25, alone or with aldesleukin; some cohorts also receive avelumab or nivolumab.

ClinicalTrials.gov ID: NCT05267626

A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

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 study enrolls adults with previously untreated, unresectable locally advanced or metastatic KRAS G12C-mutated nonsquamous NSCLC and ECOG performance status 0–1. Patients receive the investigational KRAS G12C inhibitor divarasib plus pembrolizumab, with or without pemetrexed and carboplatin or cisplatin.

ClinicalTrials.gov ID: NCT05789082

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: Adults with relapsed or metastatic solid tumors after standard therapy, including selected breast, ovarian, biliary tract, endometrial, and squamous non-small cell lung cancers, receive AZD8205 alone or in combination with rilvegostomig and/or saruparib. AZD8205 is a B7-H4–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT05123482

Phase II Trial of the Addition of Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma

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 EGFR-mutated (exon 19 deletion or L858R) non-small cell lung cancer who have developed oligoprogressive (1–5 extracranial sites) disease on first-line osimertinib monotherapy. All participants continue osimertinib (an EGFR tyrosine kinase inhibitor) and receive biologically guided radiation therapy (BgRT) and SBRT to progressive lesions.

ClinicalTrials.gov ID: NCT06014827

A Phase 1 Study of SGN-B6A in 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 study enrolls patients with measurable metastatic or unresectable solid tumors and ECOG 0–1, including previously treated patients in monotherapy cohorts and treatment-naive patients with advanced NSCLC, head and neck, or esophageal cancer in combination cohorts. Patients receive sigvotatug vedotin, an integrin β6–targeting antibody–drug conjugate that delivers the microtubule-disrupting payload MMAE, alone or with pembrolizumab, with or without platinum chemotherapy.

ClinicalTrials.gov ID: NCT04389632

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

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: For patients aged 16 years or older with previously treated advanced or metastatic solid tumors, including primary brain tumors, harboring BRAF V600 or eligible non-V600 class II or III alterations. Participants receive claturafenib (PF-07799933), an investigational brain-penetrant BRAF inhibitor, alone or with the MEK inhibitor binimetinib or the EGFR-targeting antibody cetuximab.

ClinicalTrials.gov ID: NCT05355701