Chemoradiotherapy, NSCLC Stage III, SHR-1701
Conditions
Keywords
NSCLC, SHR-1701, chemoradiotherapy
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.
Interventions
DRUGSHR-1701 combined with platinum-doublet chemotherapy induction therapy
SHR-1701 combined with platinum-doublet chemotherapy induction therapy
DRUGSHR-1701 consolidation therapy
SHR-1701 consolidation therapy
Platinum-doublet chemotherapy
RADIATIONradiotherapy
Thoracic concurrent radiotherapy, total dose 60 Gy ±10%
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Treatment-Emergent Adverse Events (TEAE) | 4 years |
Contacts
CONTACTZhengfei Zhu
Outcome results
None listed