Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| NSCLC Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| SHR-1701 | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Platinum-doublet chemotherapy | Drug | — | UNRESOLVED |
| radiotherapy | Radiation | — | UNRESOLVED |
| SHR-1701 combined with platinum-doublet chemotherapy induction therapy | Drug | — | UNRESOLVED |
| SHR-1701 consolidation therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-1701 induction Group
- description
- SHR-1701 combined with platinum-doublet chemotherapy induction therapy followed by concurrent chemoradiotherapy and SHR-1701 consolidation therapy.
- interventionNames
- Drug: SHR-1701 combined with platinum-doublet chemotherapy induction therapy
- Drug: SHR-1701 consolidation therapy
- Drug: Platinum-doublet chemotherapy
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Standard concurrent chemoradiotherapy followed by SHR-1701 consolidation therapy
- interventionNames
- Drug: SHR-1701 consolidation therapy
- Drug: Platinum-doublet chemotherapy
- Radiation: radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available