Trial intelligence / Profile preview

Quad Shot Radiotherapy Combined With Tislelizumab and Chemotherapy as Neoadjuvant Treatment for Stage II-III NSCLC

NCT07845916Phase 2

Key facts

Status: Not yet recruiting
Start: Oct 2026
Primary completion: Jun 2027
Countries: 1

Drugs: tislelizumab
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label, single-arm trial of tislelizumab in non-small cell lung cancer (NSCLC). Primary endpoint: Pathological Complete Response Rate. Planned start Oct 2026; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Neoadjuvant Quad Shot Radiotherapy + Tislelizumab + Chemotherapy
Patients receive 3 cycles of neoadjuvant therapy (every 21 days) followed by surgery.

Who it enrols

Adults with untreated, resectable stage II-IIIB NSCLC, ECOG 0-1, adequate organ function, without EGFR/ALK mutations, prior thoracic radiotherapy, or prior immunotherapy.

Endpoints

Primary

Pathological Complete Response Rate4-6 weeks after last dose

Secondary

Major Pathological Response Rate4-6 weeks after last dose
R0 Resection RateAt time of surgery
Objective Response RateUp to 14 days before surgery
Event-Free SurvivalUp to 60 months
Overall SurvivalUp to 60 months
Adverse EventsUp to 90 days after last dose
FeasibilityUp to 4-6 weeks after last dose
Quad Shot Radiotherapy-Related ToxicityUp to 90 days after last dose of radiotherapy

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