Actively Recruiting
Perioperative Tislelizumab Combined with Chemotherapy for Resectable Limited-Stage Small Cell Lung Cancer (Stage IIB-IIIB): A Phase 2 Trial
Led by Fudan University · Updated on 2025-08-07
37
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether perioperative immunotherapy combined with chemotherapy can improve survival for patients with limited-stage small cell lung cancer (SCLC) at stages IIB to IIIB. While surgery is typically recommended for early-stage SCLC, this phase II study aims to assess the safety and effectiveness of expanding surgery to later stages using this combined treatment approach. Participants will receive neoadjuvant treatment with Tislelizumab and chemotherapy drugs (Cisplatin or Carboplatin plus Etoposide) every three weeks for 2 to 4 cycles. After this, those who become eligible for surgery will undergo radical tumor removal. Following surgery, patients will receive additional cycles of Tislelizumab plus chemotherapy up to a total of four perioperative chemotherapy cycles, then continue Tislelizumab alone for one year. During the study, participants will be closely monitored with assessments for one-year event-free survival as the main outcome. Additional measures include overall survival, response rates, pathological response, surgical outcomes, and treatment side effects for up to five years. The study takes place over several years with regular evaluations to track effectiveness and safety of the treatment plan.
CONDITIONS
Brief Title
Perioperative Immunotherapy for Resectable Limited-Stage SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and agree to study requirements
- Aged 18 to 75 years at consent
- Confirmed diagnosis of small cell lung cancer by pathology
- Limited-stage disease (stage IIB to IIIB) assessed by imaging and biopsy and deemed surgically removable
- No prior cancer treatments such as chemotherapy, radiotherapy, immunotherapy, or surgery
- ECOG performance score of 0 or 1
- Expected survival more than 3 months
- Adequate bone marrow and organ function to receive platinum-based chemotherapy
- No contraindications to immunotherapy
You will not qualify if you...
- Diagnosis of non-small cell lung cancer
- Presence of brain metastases
- History or current interstitial lung disease or suspicion based on imaging
- Use of systemic corticosteroids within 14 days before starting study drug
- Prior cancer treatments including chemotherapy, radiotherapy, immunotherapy, or surgery
- Any active cancer within 2 years before enrollment
- Women who are pregnant, breastfeeding, or plan pregnancy during the study
- Uncontrolled or significant heart disease
- Active or past autoimmune or inflammatory diseases
- History of primary immunodeficiency
- Active infections
- Active bleeding disorders within 6 months before study drug
- Non-healing wounds, active ulcers, or fractures
- Any condition making the patient unsuitable for the study as judged by the investigator
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 of 3 weeks each
Participants receive neoadjuvant therapy with Tislelizumab combined with Cisplatin or Carboplatin and Etoposide before surgery.
Approximately 2 to 4 visits every 3 weeks
Duration - Single surgical procedure
Participants who are resectable after neoadjuvant therapy will undergo radical surgery.
1 visit (in-person)
Duration - Up to one year including chemotherapy cycles and monotherapy
Participants receive adjuvant therapy with Tislelizumab combined with platinum-etoposide chemotherapy for a total of four perioperative cycles, followed by Tislelizumab monotherapy for one year.
Multiple visits during chemotherapy cycles and regular visits during monotherapy
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
H
Haiquan Chen, MD, Ph.D.
F
Fangqiu Fu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here