NCT07603661Not yet recruitingPhase 2
Sintilimab Plus Chemotherapy as Induction Therapy for Unresectable Stage IIIC NSCLC
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
This is a prospective, single-center phase II study evaluating sintilimab plus chemotherapy as induction therapy for unresectable stage IIIC non-small cell lung cancer (NSCLC). Treatment-naive eligible patients who signed informed consent were enrolled after MDT screening. Patients received 4 cycles of sintilimab 200 mg intravenously every 3 weeks combined with chemotherapy. Post-treatment MDT evaluation was performed. Resectable patients underwent primary tumor resection and mediastinal lymph node dissection 4-6 weeks after the 4th cycle. Postoperative supraclavicular radiotherapy and guideline-recommended adjuvant therapy were determined by MDT and investigators. Unresectable patients received concurrent chemoradiotherapy.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 18 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT07603661
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 1 Jun 2026 to the primary completion date, 1 Jun 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
- Participation in another interventional clinical study within 4 weeks. Prior anti-PD-1/PD-L1/PD-L2 or other immune checkpoint inhibitor therapy. Systemic anti-tumor Chinese patent medicine or immunomodulatory drugs within 2 weeks.
- Active autoimmune disease requiring systemic therapy within 2 years. Systemic glucocorticoid or immunosuppressive therapy within 7 days. History of allogeneic organ transplant or hematopoietic stem cell transplant. Hypersensitivity to sintilimab or any excipient. Inadequate recovery from prior interventions (≥Grade 2). Known HIV infection. Untreated active HBV infection; active HCV infection. Live vaccine within 30 days. Pregnant or lactating women. Severe uncontrolled systemic disease (cardiac, pulmonary, hepatic, renal, infectious, etc.).
Other illness
- Other malignancy within 5 years (except cured basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ).
Who the study is looking for
- Signed written informed consent prior to any study-related procedures. Age ≥18 and ≤75 years, male or female. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). At least one measurable lesion per RECIST 1.1. Treatment-naive, initially unresectable stage IIIC NSCLC (UICC/AJCC 9th edition).
- No known EGFR/ALK sensitive mutations. Willing to undergo re-evaluation for surgery and accept surgery if eligible. No absolute contraindications to surgery. ECOG performance status 0-1. Life expectancy \>6 months. Adequate organ function. Negative pregnancy test for fertile females.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.