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

SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer: A Randomized, Phase II Clinical 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemoradiotherapy; NSCLC Stage III; SHR-1701
• Intervention / Treatment: Drug: SHR-1701 combined with platinum-doublet chemotherapy induction therapy; Drug: SHR-1701 consolidation therapy; Drug: Platinum-doublet chemotherapy; Radiation: radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhengfei Zhu; Phone Number: +8618017312901; Email: fuscczzf@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years, male or female.
• Baseline ECOG performance status 0-1.
• Histologically or cytologically confirmed unresectable stage III NSCLC
• Life expectancy ≥3 months
• No prior anti-tumor therapy
• No known EGFR/ALK/ROS1 sensitive mutations
• At least one measurable lesion according to RECIST v1.1
• Adequate organ function
• Signed informed consent

Exclusion Criteria:

• 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
• Active infection including uncontrolled HBV, HCV or HIV infection
• Significant cardiovascular disease
• Uncontrolled hypertension
• Pregnancy or breastfeeding
• Participation in another interventional clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1701 induction Group; SHR-1701 combined with platinum-doublet chemotherapy induction therapy followed by concurrent chemoradiotherapy and SHR-1701 consolidation therapy.	Drug: SHR-1701 combined with platinum-doublet chemotherapy induction therapy; SHR-1701 combined with platinum-doublet chemotherapy induction therapy; Drug: SHR-1701 consolidation therapy; SHR-1701 consolidation therapy; Drug: Platinum-doublet chemotherapy; Platinum-doublet chemotherapy; Radiation: radiotherapy; Thoracic concurrent radiotherapy, total dose 60 Gy ±10%
Active Comparator: Control Group; Standard concurrent chemoradiotherapy followed by SHR-1701 consolidation therapy	Drug: SHR-1701 consolidation therapy; SHR-1701 consolidation therapy; Drug: Platinum-doublet chemotherapy; Platinum-doublet chemotherapy; Radiation: radiotherapy; Thoracic concurrent radiotherapy, total dose 60 Gy ±10%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-Free Survival (PFS)	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	4 years
Disease Control Rate (DCR)	4 years
Objective Response Rate (ORR)	4 years
Treatment-Related Adverse Events (TRAE)	4 years
Serious Adverse Events (SAE)	4 years
Treatment-Emergent Adverse Events (TEAE)	4 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; chemoradiotherapy; SHR-1701
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Therapeutics; Radiotherapy
• Other Study ID Numbers: MA-NSCLC-II-065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No