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NCT Number: NCT07619911

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

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.

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Key information

Conditions

NSCLC Stage III Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Chemoradiotherapy Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms SHR-1701 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR-1701 combined with platinum-doublet chemotherapy induction therapy

Drug

SHR-1701 combined with platinum-doublet chemotherapy induction therapy

SHR-1701 consolidation therapy

Drug

SHR-1701 consolidation therapy

Platinum-doublet chemotherapy

Drug

Platinum-doublet chemotherapy

Radiotherapy

Radiation

Thoracic concurrent radiotherapy, total dose 60 Gy ±10%

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 4 years

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 4 years

  2. Disease Control Rate (DCR)

    Time frame: 4 years

  3. Overall Survival (OS)

    Time frame: 4 years

  4. Treatment-Related Adverse Events (TRAE)

    Time frame: 4 years

  5. Serious Adverse Events (SAE)

    Time frame: 4 years

  6. Treatment-Emergent Adverse Events (TEAE)

    Time frame: 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Zhengfei Zhu

CONTACT

[email protected]

+8618017312901

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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