Hypofractionated Chemoradiotherapy Followed by Consolidative Immunotherapy Versus Conventional Fractionated Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized Phase III Controlled Study
Led by Sun Yat-sen University · Updated on 2025-07-23
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Participants Needed
3
Research Sites
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Total Duration
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AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
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Frequently Asked Questions
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AI-Summary
What this Trial Is About
Researchers are investigating treatments for locally advanced non-small cell lung cancer (LANSCLC), focusing on comparing two radiotherapy approaches combined with immunotherapy. This phase III randomized controlled trial evaluates whether hypofractionated chemoradiotherapy followed by consolidative immunotherapy is as effective and safe as conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in patients with this condition.
Participants are randomly assigned in a 2:1 ratio to either receive hypofractionated chemoradiotherapy or conventional fractionated chemoradiotherapy. Both groups receive consolidative immunotherapy for up to 12 months after completing chemoradiotherapy. The hypofractionated group undergoes a split-course radiotherapy with specific dosing schedules and intervals, while the conventional group receives a standard fractionated radiotherapy dose. Concurrent chemotherapy with paclitaxel plus platinum-based or pemetrexed plus platinum-based agents is given during radiotherapy.
Throughout the study, participants undergo assessments of tumor response, toxicity, and quality of life at defined intervals. Researchers monitor progression-free survival over two years as the primary outcome, along with secondary outcomes including response rate, overall survival, failure patterns, adverse events, and quality of life using specific questionnaires. Safety is closely observed for one year after treatment, and the total study duration extends up to the end date in 2029, with structured follow-ups and evaluations throughout.
CONDITIONS
Brief Title
Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
Signed and dated informed consent provided before any study procedures
Male or female patients aged 18 to 75 years
Diagnosed with locally advanced, unresectable stage III non-small cell lung cancer confirmed by histological or cytological methods
Treatment-naïve or previously treated with induction chemotherapy with or without immunotherapy
Available unstained, archived tumor tissue samples sufficient for analysis
EGFR wild-type and ALK rearrangement-negative
Expected survival of at least 12 weeks
WHO performance status of 0 or 1
Postmenopausal women or women with a negative pregnancy test within 14 days before study medication
Women must not be breastfeeding
Women of childbearing potential must use contraception during treatment and for 5 months after last dose
Men with sexual partners of childbearing potential must use contraception during treatment and for 7 months after last dose
Men without sperm production are exempt from contraception
Organ and bone marrow function meeting specified laboratory parameters including FEV1 ≥ 800 mL, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 9.0 g/dL, creatinine clearance ≥ 50 mL/min, serum bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN
You will not qualify if you...
Concurrent participation in other clinical trials except observational studies
Mixed small-cell and non-small-cell lung cancer histology
Use of immunosuppressive drugs within 28 days before treatment except low-dose corticosteroids
Major surgery within 4 weeks before enrollment except vascular access procedures
History or active autoimmune diseases within past 2 years
Active or history of inflammatory bowel disease like Crohn's disease or ulcerative colitis
History of primary immunodeficiency
History of organ transplantation needing immunosuppressive therapy
Average QTc interval ≥ 470 ms on ECG
Uncontrolled comorbidities including infections, heart failure, hypertension, unstable angina, arrhythmias, peptic ulcer, bleeding disorders, hepatitis C, HIV, high HBV DNA levels
Mental or social conditions limiting study adherence or informed consent
Known history of tuberculosis
Live attenuated vaccine within 30 days before or planned during study
Another primary malignancy within past 5 years except treated basal/squamous cell carcinoma or in situ cervical cancer
Pregnancy, breastfeeding, or not using effective contraception
Presence of distant metastases or locoregional progression preventing chemoradiotherapy
WHO performance status 2-4
Impaired organ or bone marrow function below specified lab thresholds
Disease progression during chemoradiotherapy
Unresolved grade >2 toxicities or grade ≥2 pneumonitis from prior treatment
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Concurrent Chemoradiotherapy
Duration - Approximately 6 weeks
Participants receive concurrent chemotherapy combined with either hypofractionated or conventional fractionated radiotherapy to treat locally advanced non-small cell lung cancer.
Daily visits for radiation therapy over 6 to 7 weeks with concurrent chemotherapy
Consolidative Immunotherapy
Duration - Up to 12 months
Following chemoradiotherapy, participants receive PD-1/PD-L1 immune checkpoint inhibitor therapy for up to 12 months to consolidate treatment response.
Regular visits for immunotherapy administration and monitoring over 12 months
Follow-up
Duration - Up to 2 years
Participants undergo follow-up visits to monitor safety, disease progression, and quality of life after completion of consolidative immunotherapy.
Periodic visits over 2 years
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Chongqing Medical University
Fraction Dose Escalation of Hypofractionated Radiotherapy with Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-Small Cell Lung Cancer: A Phase I Study.
Hypofractionated Radiotherapy followed by Hypofractionated Boost with weekly concurrent chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: Results of A Prospective Phase II Study (GASTO-1049).
Effect of Midtreatment PET/CT-Adapted Radiation Therapy With Concurrent Chemotherapy in Patients With Locally Advanced Non-Small-Cell Lung Cancer: A Phase 2 Clinical Trial.
Feng-Ming Kong, Randall K Ten Haken, Matthew Schipper...
A phase 2 trial of consolidation pembrolizumab following concurrent chemoradiation for patients with unresectable stage III non-small cell lung cancer: Hoosier Cancer Research Network LUN 14-179.
Greg A Durm, Salma K Jabbour, Sandra K Althouse...
