NCT07619911

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
54mo left

Started Jul 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 27, 2026

Last Update Submit

May 27, 2026

Conditions

NSCLC Stage IIISHR-1701Chemoradiotherapy

Keywords

NSCLCSHR-1701chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    4 years

Secondary Outcomes (6)

  • Objective Response Rate (ORR)

    4 years

  • Disease Control Rate (DCR)

    4 years

  • Overall Survival (OS)

    4 years

  • Treatment-Related Adverse Events (TRAE)

    4 years

  • Serious Adverse Events (SAE)

    4 years

  • +1 more secondary outcomes

Study Arms (2)

SHR-1701 induction Group

EXPERIMENTAL

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 therapyDrug: SHR-1701 consolidation therapyDrug: Platinum-doublet chemotherapyRadiation: radiotherapy

Control Group

ACTIVE COMPARATOR

Standard concurrent chemoradiotherapy followed by SHR-1701 consolidation therapy

Drug: SHR-1701 consolidation therapyDrug: Platinum-doublet chemotherapyRadiation: radiotherapy

Interventions

SHR-1701 combined with platinum-doublet chemotherapy induction therapyDRUG

SHR-1701 combined with platinum-doublet chemotherapy induction therapy

SHR-1701 induction Group
SHR-1701 consolidation therapyDRUG

SHR-1701 consolidation therapy

Control GroupSHR-1701 induction Group
Platinum-doublet chemotherapyDRUG

Platinum-doublet chemotherapy

Control GroupSHR-1701 induction Group
radiotherapyRADIATION

Thoracic concurrent radiotherapy, total dose 60 Gy ±10%

Control GroupSHR-1701 induction Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Zhengfei Zhu

CONTACT

+8618017312901fuscczzf@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2030

Last Updated

June 2, 2026

Record last verified: 2026-05