Clinical Trials for Non-Small Cell Lung Cancer

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)

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 compares proton craniospinal irradiation (pCSI) versus involved-field radiotherapy (IFRT) in adult patients with leptomeningeal metastasis from breast cancer or non-small cell lung cancer, focusing on overall survival and other CNS outcomes.

ClinicalTrials.gov ID: NCT06500481

A Phase Ib Study of Vismodegib and Atezolizumab in Patients with Advanced Non-Small Cell Lung Cancer (ML43922)

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: The trial targets patients aged 18 and older with recurrent or metastatic non-small cell lung cancer who have exhausted curative treatments, investigating a combination of vismodegib, an inhibitor of the Hedgehog signaling pathway, and atezolizumab, a PD-L1 immune checkpoint inhibitor. Participants must have measurable disease and will receive treatment in a non-randomized, open-label single arm to evaluate safety, tolerability, and efficacy.

ClinicalTrials.gov ID: NCT06616623

Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% 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 targets vulnerable or older adults aged 70 or above with advanced non-small cell lung cancer (NSCLC) and a PD-L1 TPS of less than 50%, assessing the safety and efficacy of reduced dose chemotherapy with carboplatin and paclitaxel or pemetrexed (depending on histology), in combination with Pembrolizumab, an anti-PD-1 antibody therapy.

ClinicalTrials.gov ID: NCT06731413

A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

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 patients with previously untreated, locally advanced or metastatic non-squamous NSCLC with a documented KRAS G12C mutation, randomizing them to receive adagrasib (a selective KRAS G12C inhibitor) plus pembrolizumab and platinum-pemetrexed chemotherapy versus placebo plus pembrolizumab and chemotherapy. Patients may have asymptomatic, untreated brain metastases ≤ 20 mm; prior KRAS G12C inhibitor therapy is not allowed.

ClinicalTrials.gov ID: NCT06875310

LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung 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: This trial enrolls adults with advanced or metastatic NSCLC—including those post standard therapies, unresectable stage III after chemoradiotherapy, and resectable stage II/III eligible for perioperative treatment—and investigates BNT116, an mRNA cancer vaccine targeting six NSCLC antigens, as monotherapy or combined with standard chemotherapy, PD-1/CTLA-4 inhibition (cemiplimab, BNT316), and antibody–drug conjugates. Eligibility generally excludes patients with targetable mutations for which approved therapies exist.

ClinicalTrials.gov ID: NCT05142189

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 As a Single Agent and in Combination Therapy in Patients with Selected 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—including specific expansion cohorts for RCC, NSCLC, and PD-L1-negative NSCLC—who have progressed after or cannot tolerate standard therapies or are treatment naïve for metastatic disease without actionable mutations. Patients receive STK-012, an engineered IL-2 partial agonist that selectively stimulates CD25+ T cells with reduced toxicity risk, as monotherapy or in combination with pembrolizumab, and in NSCLC, with pembrolizumab plus pemetrexed and carboplatin.

ClinicalTrials.gov ID: NCT05098132

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.

HealthScout 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.

HealthScout 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 1/1b Study of CHS-388 (Formerly Known as SRF388) in Patients With 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 or metastatic solid tumors—especially clear cell renal cell carcinoma, hepatocellular carcinoma, and non-small cell lung cancer—that have progressed after standard therapy, testing the anti-IL-27 monoclonal antibody CHS-388 (casdozokitug) as monotherapy or in combination with PD-1 inhibitors (pembrolizumab or toripalimab). Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT04374877

A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) in Combination With Durvalumab (MEDI4736) and Chemotherapy in Untreated Patients With Advanced or Metastatic Adenocarcinoma 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 untreated, advanced or metastatic adenocarcinoma NSCLC (EGFR/ALK/ROS1 wild-type, ECOG 0-1) to receive first-line durvalumab (anti-PD-L1 antibody) and platinum/pemetrexed chemotherapy with either restorative microbiota therapy (an oral capsule designed to modulate the gut microbiome and potentially enhance immunotherapy efficacy) or placebo. Prior systemic therapy in the advanced/metastatic setting is not permitted.

ClinicalTrials.gov ID: NCT04105270