Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC

PHASE3RecruitingINTERVENTIONAL
Enrollment

311

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2029

Conditions
Locally Advanced Non-Small Cell Lung Cancer
Interventions
RADIATION

Hypofractionated Radiation Therapy

All patients will receive split-course hypofractionated radiotherapy. First course of radiotherapy: Total dose of 4000 cGy in 10 daily fractions (400 cGy per fraction) or 3000 cGy in 6 daily fractions (500 cGy per fraction). Three weeks after the completion of the first course of hypofractionated radiotherapy, tumor response and toxicity will be evaluated. For patients who achieve a partial response and without grade 2 or higher respiratory toxicity, a second course of radiotherapy will be planned for the residue disease at a total dose of 2000 \~2400 cGy in 5\~6 fractions (400 cGy per fraction). The interval between the two courses of radiotherapy will be 28 days.

RADIATION

Conventionally Fractionated Radiation Therapy

Patients in this group will receive a total dose of 6000- 6400 cGy in 30- 32 fractions, with 200 cGy per fraction.

DRUG

Concurrent Chemotherapy

Paclitaxel plus platinum-based chemotherapy.

DRUG

concurrent chemotherapy

Paclitaxel plus platinum-based chemotherapy or pemetrexed plus platinum-based chemotherapy.

DRUG

Consolidative immunotherapy

Following the completion of chemoradiotherapy, PD-1/PD-L1 immune checkpoint inhibitor consolidation therapy will be administered for up to 12 months.

Trial Locations (3)

400016

RECRUITING

The First Affiliated Hospital of Chongqing Medical University, Chongqing

510060

RECRUITING

Sun yat-sen University Cancer Center, Guangzhou

730050

RECRUITING

Gansu Provincial Cancer Hospital, Lanzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER