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RECRUITING
NCT07052669
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

311

Start Date

2025-07-01

Completion Date

2029-06-30

Last Updated

2025-07-23

Healthy Volunteers

No

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.

Locations (3)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China