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.
Voluntary participation in the study with signed informed consent;
Age ≥18 years, both male and female;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Estimated life expectancy ≥12 months;
Expected to be unable to tolerate surgery, radiation therapy, or ablation;
Unable to receive local treatment for all active residual lesions;
Patients with a confirmed history of malignant pleural effusion or pleural dissemination;
Pathologically diagnosed with neuroendocrine cancer at initial diagnosis (including small cell lung cancer, combined small cell lung cancer, large cell neuroendocrine carcinoma, mixed large cell neuroendocrine carcinoma, and carcinoid). Patients who do not show neuroendocrine components at initial diagnosis but develop such components in post-surgical pathology may be included;
Parallel
Immediate Local Consolidative Therapy (LCT)
Procedure/SurgeryPatients 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.
Progression-Free Survival (PFS)
Overall Survival (OS)
Safety of local consolidative therapy.
Safety follow-up will be conducted at 30 days (±5 days) after local therapy or prior to the first maintenance therapy following local therapy. Occurrence and severity of adverse events, with severity determined by NCI CTCAE v6.0 criteria.
Impact of different local consolidative treatment modalities on prognosis.
Impact of different local consolidative treatment modalities on PFS and OS.
Time from local consolidative therapy to recurrence/progression of previously existing metastatic lesions.
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This trial is not recruiting at the moment. You can still explore other options:
