A Phase 2 interventional study of SHR-1701 combined with platinum-doublet chemotherapy induction therapy and SHR-1701 consolidation therapy in NSCLC Stage III, SHR-1701 and Chemoradiotherapy, sponsored by Fudan University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 84 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 therapy · Drug: SHR-1701 consolidation therapy · Drug: Platinum-doublet chemotherapy · Radiation: radiotherapy
Standard concurrent chemoradiotherapy followed by SHR-1701 consolidation therapy
Drug: SHR-1701 consolidation therapy · Drug: Platinum-doublet chemotherapy · Radiation: radiotherapy
SHR-1701 combined with platinum-doublet chemotherapy induction therapy
SHR-1701 consolidation therapy
Platinum-doublet chemotherapy
Thoracic concurrent radiotherapy, total dose 60 Gy ±10%
Progression-Free Survival (PFS)
Time frame: 4 years
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung→
Fudan University