Clinical Trials for Non-Small Cell Lung Cancer

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic 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: Adults with measurable advanced/metastatic solid tumors eligible for standard FDA-approved immune checkpoint inhibitor therapy (anti–PD-1/PD-L1 and/or anti–CTLA-4), including NSCLC, HNSCC, RCC, biliary, HCC, and melanoma, who are ICI-naive. Patients are randomized to receive their planned standard-of-care immunotherapy in the morning versus afternoon for the first 4 doses to evaluate whether administration timing affects outcomes.

ClinicalTrials.gov ID: NCT07405086

Lorlatinib Plus Local Consolidation Therapy In ALK Positive 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.

TrialFetch AI summary: Adults with stage IV or recurrent ALK-rearranged NSCLC eligible for local consolidation therapy receive first-line lorlatinib, an oral third-generation ALK/ROS1 TKI with CNS activity, followed after induction by lorlatinib alone versus lorlatinib plus physician-selected local consolidation therapy such as radiation or other ablative approaches. Eligible patients include TKI-naïve or limited prior first-line ALK TKI exposure without progression; key exclusions include symptomatic CNS disease, significant uncontrolled cardiovascular disease, active IV-treated infection, and clinically relevant pneumonitis/ILD.

ClinicalTrials.gov ID: NCT07415005

Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial)

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 solid tumors and untreated brain metastases ≤3 cm receive physician-selected CNS-active standard-of-care therapy, including immune checkpoint inhibitors, EGFR/ALK/BRAF-MEK inhibitors, HER2-directed antibody-drug conjugates, endocrine therapy, or chemotherapy. Brain radiation is deferred with MRI surveillance in patients achieving intracranial stability or response and reserved for progression.

ClinicalTrials.gov ID: NCT06974370

A Randomized Phase II Study of Radiotherapy Plus Immune Checkpoint Inhibitor Therapy Versus Standard of Care Chemotherapy in Patients With Metastatic or Relapsed Non-Small Cell Lung Cancer Previously Treated With Immunotherapy

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 metastatic or recurrent, measurable NSCLC progressing after exactly one prior anti–PD-1/PD-L1 line, ECOG 0–2, and an ablative-radiotherapy–eligible lesion are randomized to hypofractionated ablative radiotherapy plus investigator-selected PD-1, PD-L1, and/or CTLA-4 checkpoint blockade versus standard chemotherapy such as docetaxel ± ramucirumab or gemcitabine. Sensitizing EGFR, ALK, ROS1, RET, NTRK, or HER2 alterations are excluded.

ClinicalTrials.gov ID: NCT07603856

A Phase Ib/II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)

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 untreated stage IV or recurrent metastatic NSCLC, ECOG 0–1, and no major actionable driver alterations receive first-line nivolumab (PD-1 inhibitor) plus ipilimumab (CTLA-4 inhibitor) and subcutaneous nogapendekin alfa inbakicept (N-803), an IL-15 superagonist that activates NK and CD8+ T cells. Treated, neurologically stable brain metastases are permitted.

ClinicalTrials.gov ID: NCT07355205

A Phase I Clinical Trial of Carfilzomib in Combination With Sotorasib in Patients With KRASG12C Mutated Advanced Non-Small Cell Lung Cancer

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.

TrialFetch AI summary: This trial evaluates the combination of carfilzomib, a proteasome inhibitor, and sotorasib, a KRAS G12C inhibitor, in adults with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer who have progressed after previous KRAS inhibitor treatments.

ClinicalTrials.gov ID: NCT06249282

SiCARIO (Split Course Adaptive Radioimmunotherapy) for the Treatment of Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Using Biologically-Adaptive Radiotherapy - A Phase I/II 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.

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 trial involves adults with stage IVA/IVB or locally advanced NSCLC unsuitable for standard chemoradiation, using split-course adaptive radiation therapy combined with immunotherapy agents like pembrolizumab and ipilimumab, which enhance immune targeting of cancer cells, with or without standard chemotherapy like carboplatin.

ClinicalTrials.gov ID: NCT05501665

Phase I Study of Gilteritinib for ALK Positive Non-Small Cell Lung Cancer

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.

TrialFetch AI summary: The trial involves previously treated adult patients with stage IV ALK positive non-small cell lung cancer, evaluating the safety and optimal dosing of gilteritinib, an investigational drug that targets the FLT3 receptor tyrosine kinase. Patients must have progressed on first and second-generation ALK TKIs and may have had chemotherapy or other antineoplastic treatments.

ClinicalTrials.gov ID: NCT06225427

A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in 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.

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 trial targets adults with stage IV NSCLC involving liver metastases, excluding those with EGFR or BRAF mutations and prior liver radiation, to evaluate the impact of adding liver stereotactic ablative radiotherapy (L-SABR) to a standard regimen of anti-PD-(L)1 based immunotherapy and optional platinum-based chemotherapy.

ClinicalTrials.gov ID: NCT05657873

An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab

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.

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 trial evaluates the combination of Trans-Arterial Tirapazamine Embolization (TATE) and Pembrolizumab in patients with metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC) who have liver metastases and have progressed after prior therapies. TATE delivers the hypoxia-activated prodrug Tirapazamine to liver tumors, while Pembrolizumab, an immune checkpoint inhibitor, blocks the PD-1 pathway to enhance anti-tumor immunity.

ClinicalTrials.gov ID: NCT04701476