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.

HealthScout 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 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced 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.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic urothelial cancer or NSCLC who have progressed following prior PD-1/PD-L1 inhibitor therapy, randomizing them to FF-10832 (a liposomal gemcitabine formulation enhancing tumor targeting and macrophage uptake) as monotherapy or combined with pembrolizumab. Eligible patients must have measurable disease and ECOG 0–1.

ClinicalTrials.gov ID: NCT05318573

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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null 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.

HealthScout AI summary: Adults with advanced or metastatic, histologically confirmed MTAP-null solid tumors—including NSCLC, BTC, HNSCC, pancreatic, esophageal/gastric cancers, and glioma—are eligible for treatment with AMG 193 (a selective, MTA-cooperative PRMT5 inhibitor exploiting synthetic lethality in MTAP-deleted tumors), either as monotherapy or combined with docetaxel.

ClinicalTrials.gov ID: NCT05094336

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.

HealthScout 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

Phase 1-2 Trial of Systemically Administered VSV-IFNβ-NIS in Combination With Checkpoint Inhibitor Therapy in Patients With Selected 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.

HealthScout AI summary: Eligible patients are adults with advanced or metastatic NSCLC or neuroendocrine carcinoma progressing after anti-PD-1/PD-L1 therapy, or with advanced/metastatic RCC, who will receive intravenous VSV-IFNβ-NIS (an engineered oncolytic virus delivering IFNβ for immune stimulation and expressing NIS for imaging) in combination with pembrolizumab or, for some RCC and later-phase arms, nivolumab plus ipilimumab.

ClinicalTrials.gov ID: NCT03647163

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.

HealthScout 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

Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of WSD0922-FU

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.

HealthScout AI summary: This trial enrolls adults with recurrent EGFR-mutant glioblastoma or anaplastic astrocytoma, or NSCLC patients with CNS metastases and activating EGFR mutations, who have received prior standard (and, for NSCLC, prior EGFR TKI) therapy. Participants receive WSD0922-FU, a brain-penetrant, non-competitive oral EGFR/EGFRvIII inhibitor, with dose-escalation and expansion cohorts based on disease subtype and mutation profile.

ClinicalTrials.gov ID: NCT04197934