NCT07619911Not yet recruitingPhase 2
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 · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 27 May 2026
- Start date
- Jul 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Fudan University
- Diseases
- Lung cancer
- NCT number
- NCT07619911
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 84
- From Jul 2026 to the primary completion date, Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic anti-cancer therapy within 4 weeks
Other illness
- Mixed small-cell and non-small-cell lung cancer histology
- Active autoimmune disease requiring systemic treatment
- Active infection including uncontrolled HBV, HCV or HIV infection
- Significant cardiovascular disease
- Uncontrolled hypertension
Lab values
- Known EGFR/ALK/ROS1 mutations
Other
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.