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

NCT06734702 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 497

Last updated 2025-07-24

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Neoadjuvant 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.

RADIATION

Hypo-RT and concurrent chemotherapy

Definitive dose of hypofractionated thoracic radiotherapy with concurrent chemotherapy

RADIATION

CFRT and concurrent chemotherapy

Definitive dose of conventionally fractionated thoracic radiotherapy with concurrent chemotherapy

DRUG

Consolidative 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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hui Liu, Professor · Sun yat-sen universtiy cancer center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2028-11-29
Completion
2028-11-29

Countries

  • China

Study Locations

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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 NCT06734702 on ClinicalTrials.gov