Actively Recruiting
Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial
Led by Tang-Du Hospital · Updated on 2024-07-03
104
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer (SCLC). The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University. A total of 104 patients with stage IA-IIIB SCLC (stage IIIB limited to T1-4N1-2M0) will be enrolled and randomized 1:1 to receive either Adebrelimab plus chemotherapy or chemotherapy alone. Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery. Treatment will be discontinued if patients experience disease progression, intolerable drug-related adverse events, withdrawal of informed consent, or other specified conditions during the study. Effectiveness and safety outcomes will be monitored throughout the trial. The primary objective is to evaluate pathological complete response (pCR) with Adebrelimab combination therapy. Secondary objectives include assessing event-free survival (EFS), major pathological response (mPR), objective response rate (ORR), disease-free survival (DFS), and safety.
CONDITIONS
Official Title
Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, inclusive
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Resectable or potentially resectable stage I to IIIB (T1-4N0-2M0) SCLC according to AJCC 8th edition
- Measurable tumor lesions on CT scan (long axis 650 mm for tumor, short axis 650 mm for lymph nodes)
- No prior treatment for SCLC including radiation, chemotherapy, surgery, targeted therapy, or traditional Chinese medicine
- No metastatic lesions confirmed by PET-CT, enhanced CT, ultrasound, MRI of the head, and bone scan
- Adequate cardiopulmonary function to tolerate planned lung surgery
- No laboratory contraindications to immune checkpoint inhibitors
- Normal organ function based on blood counts, liver and kidney tests, and coagulation within specified limits
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and 3 months after the study
- Male participants with female partners of childbearing potential must practice effective contraception during and 3 months after the study
- Willingness to provide informed consent, comply with study procedures, and attend follow-up visits
You will not qualify if you...
- Presence of central nervous system metastasis
- History of active autoimmune diseases including moderate or severe interstitial lung disease, uveitis, colitis, hepatitis, myocarditis, nephritis, thyroid disorders (controlled hypothyroidism or hyperthyroidism allowed)
- Immunodeficiency conditions such as HIV infection, active hepatitis B or C, or active tuberculosis
- Use of immunosuppressive drugs within 14 days prior to study start (except low-dose steroids or nasal/inhaled corticosteroids)
- Vaccination with live vaccines within 4 weeks before or planned during the study
- Any other cancer within the last 3 years
- Past or present lung diseases like pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or severely impaired lung function
- Uncontrolled high blood pressure
- Significant heart problems including recent myocardial infarction, uncontrolled arrhythmias, or heart failure NYHA Class III-IV
- Severe infection within 4 weeks before study drug administration or unexplained fever over 38.5C
- History of organ or stem cell transplantation
- Pregnant or breastfeeding women, or unwillingness to use effective contraception
- Known allergies to study drugs or their components
- Participation in another clinical trial within 4 weeks or less than 5 half-lives since last study drug
- History of substance or alcohol abuse
- Any condition that might affect safety or compliance according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China, 710038
Actively Recruiting
Research Team
X
Xiaolong Yan, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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