OncoMatch/Clinical Trials/NCT07014202
Consolidation Radiotherapy vs. Observation in Oligoresidual Advanced Non-Small Cell Lung Cancer After Chemo-Immunotherapy
Is NCT07014202 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy and Immunotherapy (with or without chemotherapy) maintenance therapy for non-small cell lung cancer.
Treatment: Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy · Immunotherapy (with or without chemotherapy) maintenance therapy — This clinical study investigates whether adding local radiation therapy (radiotherapy) to standard maintenance therapy benefits patients with advanced non-small cell lung cancer (NSCLC) who have a limited number of residual tumors after initial treatment. The primary objective is to determine if adding targeted radiation therapy to residual lesions prolongs progression-free survival in NSCLC patients with "oligo-residual lesions" (5 or fewer tumors in no more than 3 organs) following first-line chemoimmunotherapy. Researchers hypothesize that combination therapy will slow cancer progression more effectively than maintenance therapy alone. Eligible participants include adults (18+) with advanced NSCLC who have completed 4-6 cycles of first-line chemoimmunotherapy, show limited residual disease on Positron Emission Tomography-Computed Tomography (PET-CT), and lack specific genetic mutations (Epidermal Growth Factor Receptor \[EGFR\], Anaplastic Lymphoma Kinase \[ALK\], etc.). Patients will be randomized into two groups: Experimental: Continuation of maintenance therapy (immunotherapy alone or with chemotherapy) plus local radiotherapy to all residual tumors Control: Continuation of maintenance therapy only The study aims to answer: Primary: Does adding radiotherapy slow cancer progression more effectively? Secondary: Does it improve overall survival, control residual disease, and what are its effects on safety and quality of life? Participants will: Be randomly assigned to a treatment group Receive their designated treatment Undergo regular check-ups and imaging scans Complete quality of life questionnaires Potentially provide blood samples for research This research will help determine optimal treatment approaches for this specific patient population to improve outcomes and quality of life.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: ALK fusion
Excluded: EGFR sensitizing mutation
Disease stage
Metastatic disease required
advanced non-small cell lung cancer; at least one measurable lesion among the oligoresidual lesions according to RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — first-line
After receiving 4-6 cycles of first-line platinum-based chemotherapy combined with immunotherapy
Must have received: checkpoint inhibitor — first-line
After receiving 4-6 cycles of first-line platinum-based chemotherapy combined with immunotherapy
Lab requirements
Blood counts
neutrophils ≥ 1.5×10^9/l; platelets ≥ 100×10^9/l; hemoglobin ≥ 90g/l (no blood transfusion within 14 days)
Kidney function
serum cr ≤ 1×uln, endogenous creatinine clearance > 50ml/min (cockcroft-gault formula)
Liver function
ast ≤ 2.5×uln; alt ≤ 2.5×uln; if liver metastases present, alt and ast ≤ 5×uln; total bilirubin ≤ 1.5×uln (except for gilbert's syndrome subjects, where total bilirubin must be < 51.3μmol/l)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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