Actively Recruiting
Neoadjuvant Sintilimab or Combined With Chemotherapy for Stage III Gene Mutation Negative Non-small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2023-09-13
100
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of neoadjuvant Sintilimab, a PD-1 antibody, alone or combined with chemotherapy as the first treatment in patients with stage III non-small cell lung cancer (NSCLC) who do not have certain gene mutations. This phase II, open-label, multi-center study aims to assess how well these treatments work before surgery in this patient group. Participants receive Sintilimab 200 mg every three weeks intravenously for 2 to 4 cycles during the neoadjuvant treatment stage. Some also receive platinum-based chemotherapy combined with Sintilimab on the same schedule. After this, patients undergo chest CT evaluation and then have radical surgery. Following surgery, they receive additional treatment according to standard guidelines. During the study, patients undergo regular assessments including imaging to evaluate tumor response and safety monitoring for adverse events. The main measure is the major pathologic response within 5 months. Secondary outcomes include objective response rate, disease-free survival, progression-free survival, overall survival, and frequency of severe side effects, tracked up to 60 months. The total participation duration varies with follow-up visits to monitor long-term outcomes.
CONDITIONS
Brief Title
Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed the Informed Consent Form.
- Aged 18 years or older.
- Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) confirmed by needle biopsy.
- Stage III disease confirmed by imaging (CT, PET-CT, or EBUS).
- ECOG performance status score of 0 or 1.
- Life expectancy of at least 12 weeks.
- At least one measurable lesion according to RECIST 1.1.
- Feasibility or anticipated feasibility to receive radical surgery after neoadjuvant therapy.
- Good function of major organs including liver, kidney, and blood system within specified laboratory limits.
- Normal lung function able to tolerate surgery.
- No systemic metastasis (M1a, M1b, or M1c).
- Fertile females must use effective contraception during study and for 120 days after last treatment; negative pregnancy test within 7 days before enrollment.
- Unsterilized males must use effective contraception during study and for 120 days after last treatment.
You will not qualify if you...
- Non-squamous cell carcinoma with EGFR active mutation positive or ALK rearrangement.
- Prior systemic anti-cancer treatment for thymic epithelial tumor.
- Use of any Chinese medicine against cancer before drug administration.
- Other cancers (except certain cured types) within 5 years before study start.
- Unstable systemic diseases including active infection, uncontrolled hypertension, recent angina, heart failure, recent myocardial infarction, severe arrhythmia, and liver, kidney, or metabolic diseases.
- Active or suspected autoimmune disease requiring systemic treatment.
- Use of antibiotics for infection within 4 weeks prior to trial.
- Systemic corticosteroid or immunosuppressive treatment within 2 weeks prior to first dose.
- Allergy to study drug or components.
- Active hepatitis B, hepatitis C, or HIV infection.
- Vaccination within 4 weeks before trial start.
- Major surgery or severe trauma within 2 months before trial.
- Uncontrolled pleural, pericardial, or abdominal effusions requiring drainage within 2 weeks before inclusion.
- Active brain metastases or pia meningioma.
- Pregnant or lactating women.
- Nervous system or mental diseases preventing cooperation.
- Participation in another therapeutic clinical study.
- Other factors deemed unsuitable by researchers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 cycles (each cycle every 3 weeks)
Participants receive neoadjuvant therapy with Sintilimab alone or combined with chemotherapy before surgery.
2 to 4 visits (in-person, every 3 weeks)
Duration - Up to 1 week
Participants undergo radical surgery following neoadjuvant treatment.
1 visit (in-person)
Duration - Variable according to clinical guidelines
Participants receive additional treatment according to clinical guidelines after surgery.
Visit schedule according to standard care; specific visits not defined in protocol
Duration - Up to 60 months
Participants are monitored for safety and disease outcomes including survival and recurrence.
Regular visits over 5 years according to study schedule
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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