Clinical Trials for Non-Small Cell Lung Cancer

Phase II Randomized Controlled Trial of Biologically Guided Stereotactic Body Radiation Therapy in Oligoprogressive Non-Small Cell Lung Cancer, Melanoma, and Renal Cell 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: Adults with oligoprogressive NSCLC, melanoma, or renal cell carcinoma (1-5 progressing sites while on or after checkpoint inhibitor therapy) are randomized to receive either standard SBRT or a PET-guided, biologically adaptive SBRT approach that uses PET/CT to guide dose escalation to metabolically active tumor regions. All participants must have lesions suitable for SBRT and ECOG performance status ≤2.

ClinicalTrials.gov ID: NCT05830058

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic 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 previously treated advanced or metastatic solid tumors, primarily HER2-expressing disease; one cohort permits HER2-null tumors. Patients receive trastuzumab pamirtecan (DB-1303/BNT323), a HER2-directed antibody–drug conjugate carrying a topoisomerase I inhibitor payload, with one cohort also receiving pertuzumab.

ClinicalTrials.gov ID: NCT05150691

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic 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: Adults with previously treated unresectable or metastatic solid tumors, including selected ovarian, endometrial, breast, non-small cell lung cancer, and mesothelioma populations, receive Rina-S alone or with carboplatin, bevacizumab, or pembrolizumab. Rina-S is an investigational FRα-targeting antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT05579366

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants 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.

TrialFetch AI summary: Adults with advanced or metastatic solid tumors that have progressed after their most recent therapy receive investigational BMS-986340 alone or with nivolumab or docetaxel. BMS-986340 is an anti-CCR8 antibody designed to deplete tumor regulatory T cells.

ClinicalTrials.gov ID: NCT04895709

A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study

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 patients aged 70 or older with stage IIIB-IV NSCLC, ECOG 2, and PD-L1 TPS 1-49% (without actionable mutations or chemo-radiation candidacy) to compare pembrolizumab (anti-PD-1 immunotherapy) plus platinum-based chemotherapy versus pembrolizumab alone. Both arms include pembrolizumab maintenance, with the primary outcome of overall survival.

ClinicalTrials.gov ID: NCT06096844

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor Malignancies

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 measurable, locally advanced or metastatic EGFR-expressing solid tumors who have progressed on or cannot tolerate established therapies receive weekly intravenous JANX008, a protease-activated, masked EGFR×CD3 T-cell engager designed to activate in the tumor microenvironment. The sponsor has discontinued JANX008 development because of insufficient magnitude and consistency of activity.

ClinicalTrials.gov ID: NCT05783622

A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

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 or recurrent non-small cell lung cancer harboring MET exon 14 skipping mutations who have progressed after at least one prior systemic therapy, testing tepotinib (oral MET tyrosine kinase inhibitor) with or without ramucirumab (IV VEGFR2 inhibitor). Patients must not have prior exposure to MET or angiogenesis inhibitors and must lack other actionable mutations.

ClinicalTrials.gov ID: NCT06031688

A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)

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 HER2-overexpressing, unresectable locally advanced or metastatic non-squamous NSCLC and ECOG performance status 0–1; current cohorts require no prior systemic therapy for advanced disease and exclude tumors with actionable drivers that have approved treatments. Patients receive trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor, with either volrustomig (PD-1/CTLA-4 bispecific) or rilvegostomig (PD-1/TIGIT bispecific), with or without carboplatin.

ClinicalTrials.gov ID: NCT04686305

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.

TrialFetch 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

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.

TrialFetch 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