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Integrating Surgery and Radiotherapy Following Tislelizumab-based Conversion Therapy in N3-Stage III NSCLC

NCT06908733 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-03

No results posted yet for this study

Summary

This is a prospective, open, multicenter, Phase II single-arm clinical study. In subjects with an initial stage of stage III-N3 non-small cell lung cancer (NSCLC) that was negative for sensitive gene mutations and had not received any systemic or local therapy (T1-4N3M0, excluding primary tumor or metastatic lymph node invasion of the aorta/trachea/esophagus/heart, etc.); After 3-4 cycles of Tislelizumab combined with platinum-containing dual agents, the patients without disease progression were evaluated by MDT and selected according to the patient's wishes, including those who could receive conventional/standard radical lung cancer surgery (excluding total lung resection). Conventional/standard resection of primary, ipsilateral hilum and ipsilateral mediastinum combined with hypofractionted chemoradiotherapy of N3 metastatic lymph nodes was performed. For patients who are inoperable or unwilling to undergo surgery or intolerant to surgery, conventional concurrent chemoradiotherapy is given. Maintenance therapy with Tislelizumab was continued after local treatment until disease progression, drug intolerance as assessed by imaging, or after 1 year; Participants were followed up according to the procedure to evaluate efficacy and patient-reported outcomes.

The study included a screening period (no more than 28 days after subjects signed informed consent to the first dose), a treatment period (including Tislelizumab combined with chemotherapy-restaging and MDT-local treatment-maintenance therapy), and a follow-up period.

Thirty patients：30 patients Primary endpoint: 1-year EFS rate Secondary endpoints: EFS, OS, surgical rate, TTDM, TTLR, AEs, PROs Exploratory end points: Imaging efficacy, pathological efficacy and other relevant clinical outcomes; Predictive biomarkers based on tissue and blood samples.

Conditions

  • Non-Small Cell Lung Cancer (Stage III)

Interventions

DRUG

3-4 cycles of Tislelizumab combined with platinum-based chemotherapy, evaluated by MDT and assigned to treatment strategies based on eligibility and patient preference.

Patients deemed eligible to surgery will receive standard lung cancer resection (excluding total pneumonectomy)

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2027-09-30
Completion
2029-12-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06908733 on ClinicalTrials.gov