Clinical Trials for Non-Small Cell Lung Cancer

Single Arm Study to Assess the Immune Effects of Fermented Wheat Germ (FWG) Nutritional Supplementation in Patients With Advanced Malignancies Being Treated With Standard of Care Checkpoint Inhibitor-Based Therapy

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: Adults with advanced non-small cell lung, renal cell, melanoma, colorectal, or triple-negative breast cancers eligible for standard checkpoint inhibitor immunotherapy will receive oral fermented wheat germ supplementation (a nutritional product with proposed but unproven immunomodulatory effects) alongside their standard immunotherapy regimen. No chemotherapy, radiotherapy, or recent immunomodulatory agents are allowed prior to enrollment.

ClinicalTrials.gov ID: NCT05967533

LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic 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 previously untreated, stage IV non-squamous or squamous NSCLC without actionable driver mutations, randomizing them to receive pembrolizumab plus platinum-based chemotherapy with or without Tumor Treating Fields (TTFields), a therapy using low-intensity alternating electric fields to disrupt cancer cell mitosis.

ClinicalTrials.gov ID: NCT06216301

Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other 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 include adults with advanced or metastatic NSCLC, HNSCC, gastric/GEJ, ESCC, or other solid tumors with defined molecular alterations, who have progressed on or are intolerant to prior therapy; both treatment-naive and previously treated patients are allowed. Patients receive MCLA-129, a bispecific EGFR/c-MET antibody, as monotherapy or in combination with osimertinib or standard chemotherapy.

ClinicalTrials.gov ID: NCT04868877

A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With ABBV-514 as a Single Agent and in Combination With Budigalimab

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, including NSCLC or HNSCC, who have progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitors, and are treated with ABBV-514 (an anti-CCR8 monoclonal antibody designed to deplete tumor-infiltrating Tregs) as monotherapy or in combination with budigalimab (a PD-1 inhibitor). NSCLC patients with EGFR or ALK alterations are excluded from the dose-expansion cohorts.

ClinicalTrials.gov ID: NCT05005403

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic 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 or metastatic NSCLC harboring common EGFR mutations (Ex19del or Ex21 L858R), testing subcutaneous amivantamab (a bispecific EGFR/MET antibody) combined with lazertinib as first-line therapy, or with platinum-based chemotherapy as second-line therapy. Patients must have good performance status, measurable disease, and no active ILD.

ClinicalTrials.gov ID: NCT06667076

A Single-Arm Phase 2 Study of Daratumumab Subcutaneous (SC) in Previously Treated STK11/LKB1 Mutated 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 metastatic or unresectable NSCLC harboring STK11/LKB1 mutations who have progressed after immunotherapy, platinum doublet chemotherapy, and any indicated targeted therapy; patients receive subcutaneous daratumumab, a CD38-targeting monoclonal antibody with immunomodulatory and cytotoxic activity, until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT05807048

A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)

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 lacking EGFR/ALK alterations (treatment-naïve or with limited prior therapy, including checkpoint inhibitor-resistant disease) to receive the TROP2-targeting antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) in combination with novel immunotherapies (including PD-1/TIGIT, PD-1/CTLA-4, or PD-1/TIM-3 agents), with or without carboplatin. Patients must have measurable disease, ECOG PS 0-1, and adequate organ function, and will undergo mandatory tumor biopsies.

ClinicalTrials.gov ID: NCT04612751

A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors harboring a KRAS G12C mutation to receive the investigational oral KRAS G12C inhibitor GDC-6036 (divarasib), either as monotherapy or in combination with agents such as atezolizumab, cetuximab, bevacizumab, erlotinib, GDC-1971 (SHP2 inhibitor), or inavolisib (PI3Kα inhibitor). Patients must have no active brain metastases or significant organ dysfunction.

ClinicalTrials.gov ID: NCT04449874

KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV 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 previously untreated stage IV squamous or non-squamous NSCLC (without targetable driver mutations) to receive pembrolizumab plus chemotherapy combined with an investigational immunotherapy or antibody-drug conjugate targeting TIGIT (vibostolimab), CD27 (boserolimab), ILT4 (MK-4830), ILT3 (MK-0482), B7-H3 (I-DXd), or HER3 (HER3-DXd). Patients must have available tumor tissue and good organ function; those with active CNS disease, significant comorbidities, or prior systemic therapy for metastatic NSCLC are excluded.

ClinicalTrials.gov ID: NCT04165070

A Phase Ib-II Trial of Tocilizumab and Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy

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: Eligible patients are adults with advanced non-squamous NSCLC whose disease has progressed after at least one prior checkpoint inhibitor-based regimen, without targetable driver mutations or uncontrolled CNS disease. Treatment consists of atezolizumab (PD-L1 inhibitor) combined with tocilizumab (an IL-6 receptor blocker thought to counteract resistance to immunotherapy).

ClinicalTrials.gov ID: NCT04691817