Actively Recruiting
An Open-Label, Single-Arm, Phase II Study of Pembrolizumab, Plinabulin Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer
Led by Xiaorong Dong · Updated on 2025-02-11
45
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new combination treatment for patients with extensive-stage small-cell lung cancer (ES-SCLC). This phase II study focuses on evaluating the safety and effectiveness of Pembrolizumab, Plinabulin, Etoposide, and Platinum as a first-line therapy. Pembrolizumab, a drug that targets PD-1, has shown promising results when combined with chemotherapy. Plinabulin, recently approved for preventing chemotherapy-induced neutropenia, is being tested alongside Pembrolizumab and chemotherapy to improve treatment response and reduce side effects in this patient group. Participants will receive Pembrolizumab 200 mg intravenously every three weeks, along with Etoposide on days 1, 2, and 3, and either Carboplatin or Cisplatin on day 1 every three weeks. Plinabulin will also be given intravenously on day 1 every three weeks. This single-arm trial involves receiving this combination as the first treatment for ES-SCLC, with treatment cycles continuing as planned according to the study protocol. During the study, participants will undergo regular assessments to monitor disease progression, treatment response, and safety. The main outcome measured is the progression-free survival rate at 12 months, with additional evaluations including overall response rate, duration of response, overall survival, and treatment-related side effects over up to 24 months. Participants will be closely observed for adverse events and treatment effects throughout the study period.
CONDITIONS
Brief Title
First Line Pembrolizumab, Plinabulin Plus Etoposide and Platinum (EP) for ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented new diagnosis of small cell lung cancer by tissue or cytology
- Extensive-stage disease defined as Stage IV by AJCC Eighth Edition
- At least one measurable lesion based on RECIST 1.1 criteria
- Life expectancy of 3 months or more
- ECOG performance status of 0 or 1
- Male or female aged 18 years or older
- Provides written informed consent
- Adequate organ function
- For Hepatitis B positive: on antiviral therapy for at least 4 weeks with undetectable viral load
- For Hepatitis C history: completed curative antiviral therapy at least 4 weeks prior and undetectable viral load
- Male participants agree to use contraception during treatment and for 180 days after last dose
- Female participants not pregnant or breastfeeding
You will not qualify if you...
- Prior systemic therapy for small cell lung cancer
- Radiotherapy within 2 weeks before starting study treatment unless recovered from toxicities
- Participation in another investigational study within 4 weeks before treatment
- Expected need for other antineoplastic therapy during study
- Active central nervous system metastases or carcinomatous meningitis
- Major surgery within 3 weeks before treatment or incomplete recovery
- Active autoimmune disease requiring recent systemic treatment
- Symptomatic ascites, pleural or pericardial effusion unless stable after treatment
- Other progressing malignancies requiring active treatment within past 3 years
- Severe hypersensitivity to pembrolizumab or plinabulin
- History or current pneumonitis or interstitial lung disease requiring steroids
- Known HIV infection
- Psychiatric or substance abuse disorders interfering with participation
- Prior therapy with anti-PD-1/PD-L1/PD-L2 or related agents
- Allogenic tissue or organ transplant
- Live vaccine within 30 days before treatment
- Active tuberculosis
- Medical conditions posing excessive risk as judged by investigator
- Pregnancy, breastfeeding, or planning to conceive/father children during study
- Active uncontrolled infection requiring systemic therapy
- Immunodeficiency or recent high-dose immunosuppressive therapy
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 - Repeated 3-week cycles until disease progression or discontinuation
Participants receive Pembrolizumab, Plinabulin, Etoposide, and Platinum as first-line therapy for extensive-stage small-cell lung cancer.
Visits every 3 weeks for treatment administration
Trial Site Locations
Total: 1 location
1
Union hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
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