SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1701 combined with platinum-doublet chemotherapy induction therapy, SHR-1701 consolidation therapy, Platinum-doublet chemotherapy, radiotherapy.
- Who it may be relevant to
- Registry conditions: NSCLC Stage III, SHR-1701, Chemoradiotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer: A Randomized, Phase II Clinical Trial
Overview
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.
Interventions
- 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%
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: 4 years]
Secondary outcome measures (6)
- Objective Response Rate (ORR) [Time frame: 4 years]
- Disease Control Rate (DCR) [Time frame: 4 years]
- Overall Survival (OS) [Time frame: 4 years]
- Treatment-Related Adverse Events (TRAE) [Time frame: 4 years]
- Serious Adverse Events (SAE) [Time frame: 4 years]
- Treatment-Emergent Adverse Events (TEAE) [Time frame: 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07619911 · MA-NSCLC-II-065