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Local Consolidative Therapy Versus Maintenance Immunotherapy After First-Line Chemoimmunotherapy in Metastatic NSCLC
Sponsor: Guangdong Provincial People's Hospital
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
Conditions
Interventions
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