Actively Recruiting
Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC
Led by Sun Yat-sen University · Updated on 2025-07-23
311
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC). Radiotherapy strategies for maximizing efficacy and local control require further investigation. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients.
CONDITIONS
Official Title
Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before any study procedures
- Male or female patients aged 18 to 75 years
- Diagnosis of locally advanced, unresectable (stage III) non-small cell lung cancer confirmed by histology or cytology
- Treatment-nafve or previously treated with induction chemotherapy with or without immunotherapy
- Availability of sufficient unstained archived tumor tissue samples for analysis
- EGFR wild-type and ALK rearrangement-negative tumor status
- Expected survival of at least 12 weeks
- WHO Performance Status of 0 or 1
- For women: postmenopausal or negative pregnancy test within 14 days before study medication
- Women must not be breastfeeding
- Women of childbearing potential must agree to use contraception during treatment and for 5 months after last dose
- Men who have sexual relations with women of childbearing potential must agree to use contraception during treatment and for 7 months after last dose
- Men with no sperm production are exempt from contraception requirements
- Adequate organ and bone marrow function as defined by specific laboratory criteria including FEV1 800 mL, ANC 1.5 � 10�b9/L, platelets 100 � 10�b9/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...
- Participation in another clinical trial 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 prior to enrollment except vascular access procedures
- History or active autoimmune diseases within past two years
- Active or history of inflammatory bowel disease
- History of primary immunodeficiency
- History of organ transplantation requiring immunosuppressive therapy
- Average corrected QT interval 470 ms
- Uncontrolled infections or comorbidities including congestive heart failure, hypertension, unstable angina, arrhythmias, peptic ulcer, bleeding disorders, hepatitis C, HIV, or active HBV with high viral load
- Mental or social conditions affecting consent or study adherence
- Known history of tuberculosis
- Receipt of live attenuated vaccine within 30 days before study or planned during study
- History of another primary malignancy within 5 years except certain skin or cervical cancers
- Pregnancy, breastfeeding, or not using effective contraception
- For experimental group: distant metastases, locoregional progression preventing chemoradiotherapy, WHO performance status 2-4, impaired organ or bone marrow function below specified thresholds
- For consolidation immunotherapy: disease progression during chemoradiotherapy, use of immunosuppressive drugs within 28 days before immunotherapy except low-dose corticosteroids, unresolved toxicities greater than grade 2, grade 2 or higher pneumonitis, prior severe immune-related adverse events or unresolved adverse events greater than grade 1
AI-Screening
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Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
2
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Actively Recruiting
3
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
B
Bo Qiu, Professor
CONTACT
H
Hui Liu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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