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NOT YET RECRUITING
NCT07842471
PHASE2

Local Consolidative Therapy Versus Maintenance Immunotherapy After First-Line Chemoimmunotherapy in Metastatic NSCLC

Sponsor: Guangdong Provincial People's Hospital

View on ClinicalTrials.gov

Summary

This study explores the difference in progression-free survival (PFS) between local consolidative therapy (LCT arm) targeting residual lesions and continued systemic therapy (non-LCT arm) in patients with metastatic NSCLC who have achieved at least partial response (PR) following first-line chemoimmunotherapy. In this process, a multidisciplinary team (MDT) comprising surgical oncology, radiation oncology, and medical oncology will be integrated to administer local treatment modalities-including surgery, radiotherapy, and ablation-for oligometastatic lesions, aiming to address critical clinical questions regarding the optimal beneficiary population for local therapy, the best local treatment modality, and the optimal timing of local intervention.

Official title: A Phase II, Multicenter, Randomized, Patient-Centered Study of the Efficacy and Safety of Immediate Local Consolidative Therapy (LCT) Versus Continued Immunotherapy Maintenance or Delayed Local Therapy (Non-LCT) After First-Line Chemoimmunotherapy in Metastatic NSCLC, Assessed by MDT

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

117

Start Date

2026-10-08

Completion Date

2032-12-31

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

PROCEDURE

Immediate Local Consolidative Therapy (LCT)

Patients with stage IV disease (9th edition TNM staging) who have received 4-6 cycles of first-line immunotherapy combined with platinum-based doublet chemotherapy, achieved at least partial response (PR) upon efficacy assessment, demonstrated metabolically active residual lesions on PET evaluation, and been clinically assessed by the multidisciplinary team (MDT) as amenable to individualized local therapy. And then receiving local treatment targeting residual lesions, followed by physician-assessed continuation of maintenance systemic therapy or surveillance monitoring; optional local treatment modalities include surgery, radiotherapy, and ablation.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangzhou, China