Clinical Trials for Non-Small Cell Lung Cancer

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

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 have locally advanced or metastatic solid tumors with HER2 expression—including NSCLC, breast (both HER2+ and HER2-), urothelial, gastric, esophageal, or other Erbb2-amplified cancers—who have progressed on or are intolerant to standard treatments. Patients receive DF1001, a tri-specific NK cell engager targeting HER2 and activating NK and T cells, as monotherapy or in combination with nivolumab, nab-paclitaxel, or sacituzumab govitecan-hziy.

ClinicalTrials.gov ID: NCT04143711

A Multicenter Phase II Randomized Trial Of Immunotherapy Versus Chemotherapy Guided By Circulating Tumor DNA-Based Molecular Response On Patients With Metastatic NSCLC

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 NSCLC, positive PD-L1 (≥1%), detectable ctDNA, and no actionable driver mutations, to compare nivolumab plus ipilimumab (immune checkpoint inhibitors) with or without addition of platinum-doublet chemotherapy based on early ctDNA response. Treatment is adapted according to ctDNA response after initial immunotherapy.

ClinicalTrials.gov ID: NCT05715229

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue Metastases

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 solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767

A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-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 advanced or metastatic NSCLC, especially those with EGFR mutations (exon 19 deletion, exon 21 L858R, or exon 20 insertion) at various lines of therapy, to evaluate subcutaneous amivantamab—a bispecific EGFR/MET antibody—given alone or in combination with lazertinib, chemotherapy, or following IV amivantamab. Key exclusions include symptomatic brain metastases, significant cardiovascular disease, or history of ILD.

ClinicalTrials.gov ID: NCT05498428

A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants with BRAF And/or NRAS Mutation-positive 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 with BRAF Class I, II, or III mutations, or NRAS-mutant melanoma, to receive KIN-2787 (exarafenib)—a novel pan-RAF inhibitor—either as monotherapy or in combination with the MEK inhibitor binimetinib. Prior BRAF-, MEK-, or MAPK-directed therapies are excluded in the dose expansion phase.

ClinicalTrials.gov ID: NCT04913285

A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater

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 metastatic squamous or nonsquamous NSCLC and PD-L1 TPS ≥50%, randomizing them to receive either subcutaneous pembrolizumab coformulated with hyaluronidase (which enhances drug absorption) or standard intravenous pembrolizumab, both targeting PD-1 to stimulate antitumor immunity.

ClinicalTrials.gov ID: NCT06698042

Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations

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 HER2 aberrations, with a focus on NSCLC patients with HER2 mutations, including those previously treated, treatment-naïve, or with brain metastases. Patients receive zongertinib, an oral, selective covalent tyrosine kinase inhibitor targeting both wild-type and mutant HER2 while sparing EGFR.

ClinicalTrials.gov ID: NCT04886804

ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics

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 EGFR-mutant NSCLC and at least one measurable brain metastasis (≥1 cm) who are TKI-naïve or recently started osimertinib, randomizing them after 3 months of osimertinib to either continue osimertinib alone or add stereotactic radiosurgery (SRS) to residual brain metastases. It excludes patients with prior brain-directed radiotherapy, leptomeningeal disease, or more than 20 brain metastases after initial TKI therapy.

ClinicalTrials.gov ID: NCT06741085

A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours

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 locally advanced or metastatic FAP-positive solid tumors, including high-grade soft-tissue sarcoma, salivary gland carcinoma, and triple-negative breast cancer, who have progressed on or are ineligible for standard therapies. Patients receive intravenous AVA6000, a FAP-activated doxorubicin prodrug designed to deliver doxorubicin selectively to tumor tissue in order to minimize systemic toxicity.

ClinicalTrials.gov ID: NCT04969835

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