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RECRUITING
NCT06734702
PHASE3

Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer

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), leading to a 5-year survival rate of over 40%. The optimal timing of radiotherapy combined with immunotherapy still requires further exploration. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy, compared with concurrent chemoradiotherapy and consolidative immunotherapy in LANSCLC patients.

Official title: Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy Compared With Concurrent Chemoradiotherapy and 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

497

Start Date

2024-11-30

Completion Date

2028-11-29

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DRUG

Neoadjuvant therapy

The neoadjuvant regimen prior to radiotherapy consists of albumin-bound paclitaxel 260 mg/m², cisplatin 75 mg/m², and tislelizumab 200 mg, administered every 3 weeks.

RADIATION

Hypo-RT and concurrent chemotherapy

Definitive dose of hypofractionated thoracic radiotherapy with concurrent chemotherapy

RADIATION

CFRT and concurrent chemotherapy

Definitive dose of conventionally fractionated thoracic radiotherapy with concurrent chemotherapy

DRUG

Consolidative immunotherapy

Following the completion of chemoradiotherapy, Tislelizumab consolidation therapy will be administered based on treatment efficacy and the patient's physical condition, for a total duration of 1 year, starting 1-2 months after chemoradiotherapy.

Locations (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China