OncoMatch/Clinical Trials/NCT05501665
Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
Is NCT05501665 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for lung non-small cell carcinoma.
Treatment: Carboplatin · Nab-paclitaxel · Pembrolizumab · Pemetrexed · Ipilimumab · Nivolumab · Cemiplimab · Atezolizumab — This phase I/II trial tests the safety and efficacy of split-course adaptive radiation therapy in combination with immunotherapy with or without chemotherapy for the treatment of patients with stage IV lung cancer or lung cancer that that has spread to nearby tissue or lymph nodes (locally advanced). Radiation therapy is a standard cancer treatment that uses high energy rays to kill cancer cells and shrink tumors. Split-course adaptive radiation therapy uses patient disease response to alter the intensity of the radiation therapy. Immunotherapy with monoclonal antibodies such as pembrolizumab, ipilimumab, cemiplimab, atezolizumab or nivolumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs like carboplatin, pemetrexed, and paclitaxel work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving split-course adaptive radiation therapy with standard treatments like immunotherapy and chemotherapy may be more effective at treating stage IV or locally advanced lung cancer than giving them alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Available tumor material (< 6 months old) adequate for confirmation of programmed cell death 1 ligand 1 (PD-L1) expression per local standard of care testing
Required: EGFR mutation
Confirmed candidate (per study physician) for alternative systemic therapy if preferred by treating physician (i.e. mEGFR, ALK, KRAS G12C or ROS1 mutations). Testing not required for enrollment
Required: ALK fusion
Confirmed candidate (per study physician) for alternative systemic therapy if preferred by treating physician (i.e. mEGFR, ALK, KRAS G12C or ROS1 mutations). Testing not required for enrollment
Required: KRAS G12C
Confirmed candidate (per study physician) for alternative systemic therapy if preferred by treating physician (i.e. mEGFR, ALK, KRAS G12C or ROS1 mutations). Testing not required for enrollment
Required: ROS1 fusion
Confirmed candidate (per study physician) for alternative systemic therapy if preferred by treating physician (i.e. mEGFR, ALK, KRAS G12C or ROS1 mutations). Testing not required for enrollment
Disease stage
Required: Stage IVA, IVB (AJCC v8)
stage IVA or IVB (M1b or M1c) or locally advanced (not eligible for standard of care [SOC] chemoradiation) non-small cell lung cancer with evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: immune checkpoint inhibitor
Exception: prior ≤1 cycle for current malignancy allowed
Receipt of prior >1 cycle of immune checkpoint inhibitor for current malignancy (prior cytotoxic chemotherapy is allowed)
Cannot have received: radiotherapy
Exception: allowed unless would preclude protocol-based radiotherapy to normal organ tolerance
Prior radiotherapy that would preclude delivery of protocol-based radiotherapy to normal organ tolerance per patient's study physician
Lab requirements
Blood counts
adequate organ function to receive therapy as determined by investigators and other treating physicians
Kidney function
adequate organ function to receive therapy as determined by investigators and other treating physicians
Liver function
adequate organ function to receive therapy as determined by investigators and other treating physicians
Adequate organ function to receive therapy as determined by investigators and other treating physicians
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Vanderbilt University/Ingram Cancer Center · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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