SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This randomized phase II exploratory clinical study aims to evaluate the efficacy and safety of SHR-1701 in patients with unresectable stage III non-small cell lung cancer (NSCLC). A total of 84 eligible patients will be randomized 1:1 into an induction immunotherapy group or a consolidation immunotherapy group. Group A will receive SHR-1701 combined with platinum-based chemotherapy as induction therapy followed by concurrent chemoradiotherapy (cCRT) and subsequent SHR-1701 consolidation therapy, while Group B will receive standard cCRT followed by SHR-1701 consolidation therapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety outcomes.

Eligibility criteria

Qualifiers

Age ≥18 years, male or female.

Baseline ECOG performance status 0-1.

Histologically or cytologically confirmed unresectable stage III NSCLC

Life expectancy ≥3 months

Disqualifiers

Mixed small-cell and non-small-cell lung cancer histology

Known EGFR/ALK/ROS1 mutations

Prior systemic anti-cancer therapy within 4 weeks

Active autoimmune disease requiring systemic treatment

Trial design

Treatments tested in this trial

  • SHR-1701 combined with platinum-doublet chemotherapy induction therapy
  • SHR-1701 consolidation therapy
  • Platinum-doublet chemotherapy
  • radiotherapy

Treatment groups

84 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators