RecruitingPhase 3NCT06734702

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

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

Sponsor

Sun Yat-sen University

Enrollment

497 participants

Start Date

Nov 30, 2024

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy Immunotherapy Locally Advanced Non-Small Cell Lung Cancer Concurrent Chemoradiotherapy

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy before, during, and after radiation plus chemotherapy improves outcomes for patients with locally advanced, inoperable (Stage III) non-small cell lung cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with Stage III non-small cell lung cancer (NSCLC) confirmed by biopsy - You have not received any prior treatment for this cancer (no chemotherapy, radiation, surgery, or immunotherapy) - Your general health is good enough to tolerate treatment **You may NOT be eligible if...** - You have already received prior treatment for lung cancer - Your cancer is operable (can be removed by surgery) - You are in poor general health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant 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.

RADIATIONHypo-RT and concurrent chemotherapy

Definitive dose of hypofractionated thoracic radiotherapy with concurrent chemotherapy

RADIATIONCFRT and concurrent chemotherapy

Definitive dose of conventionally fractionated thoracic radiotherapy with concurrent chemotherapy

DRUGConsolidative 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.