Actively Recruiting
First Line Pembrolizumab, Plinabulin Plus Etoposide and Platinum (EP) for ES-SCLC
Led by Xiaorong Dong · Updated on 2025-02-11
45
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Monoclonal antibodies against programmed death 1 (PD-1) and its ligand PD-L1 have shown efficacy in patients with ES-SCLC in the monotherapy and combination therapy settings. Up to now, Atezolizumab and Durvalumab has been approved for first line treatment for ES-SCLC in China combined with EP or EC. Besides, KEYNOTE-604 study revealed that adding pembrolizumab to standard first-line EP significantly improves PFS in patients with ES-SCLC and is associated with durable responses in a subset of patients. 12-m PFS rate were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. The statistical threshold for declaring significant prolongation of OS was narrowly missed. Considering sicker pts was enrolled and the interim analysis was quite often, even though the investigators narrowly missed the OS endpoint, longer numerical OS data was observed. The latest version of NCCN SCLC guidelines still recommended pembrolizumab as an option for ES-SCLC patients. Plinabulin received breakthrough designation from both US and China FDA for CIN (Chemotherapy Induced Neutropenia) prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody resistant patients. In a poster released at 2021 ASCO conference, a phase I trial of Plinabulin in combination with nivolumab and ipilimumab in patients with relapsed small cell lung cancer: Big Ten Center Research Consortium (BTCRC-LUN17-127) study. Plinabulin in combination with nivolumab and ipilimumab was safe and well tolerated with promising efficacy signal of 46% ORR. From above, Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC should be a promising combination therapy, as the investigators expect increased efficacy and reduced toxicity with the addition of Plinabulin. In this proof of concept phase II study, the investigators will investigate that the efficacy and safety of Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC.
CONDITIONS
Official Title
First Line Pembrolizumab, Plinabulin Plus Etoposide and Platinum (EP) for ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a documented new diagnosis of small cell lung cancer by histology or cytology
- Have extensive stage disease defined as Stage IV (T any, N any, M 1a/b) by AJCC 8th Edition
- Have at least 1 measurable lesion per RECIST 1.1
- Life expectancy of at least 3 months
- ECOG performance status of 0 or 1
- Male or female aged 18 years or older
- Provide written informed consent
- Have adequate organ function
- Hepatitis B positive participants must have received antiviral therapy for at least 4 weeks with undetectable viral load and continue antiviral therapy during study
- Hepatitis C participants must have undetectable viral load and completed curative antiviral therapy at least 4 weeks before treatment
- Male participants must agree to use contraception during treatment and for 180 days after last dose and avoid sperm donation
- Female participants must not be pregnant or breastfeeding
You will not qualify if you...
- Prior systemic therapy for small cell lung cancer
- Radiotherapy within 2 weeks before study start, with recovery from toxicities and no corticosteroid use; 1-week washout allowed for palliative radiation to non-CNS disease
- Participation in another investigational study with therapy or device within 4 weeks before treatment
- Expected to require other antineoplastic therapy for small cell lung cancer during study
- Active CNS metastases or carcinomatous meningitis; treated brain metastases must be stable for at least 4 weeks without steroids
- Major surgery within 3 weeks before treatment or not recovered from surgery complications
- Active autoimmune disease requiring systemic treatment in past 2 years
- Symptomatic ascites, pleural or pericardial effusion unless clinically stable after treatment
- Other malignancy progressing or requiring treatment in past 3 years, excluding certain skin and bladder carcinomas
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or plinabulin
- History or current pneumonitis/interstitial lung disease requiring steroids
- Known HIV infection
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar agents or participation in related pembrolizumab or plinabulin trials
- Allogenic tissue or solid organ transplant
- Live vaccine within 30 days before treatment
- Known active tuberculosis
- Medical conditions posing excessive risk as judged by investigator
- Pregnant, breastfeeding, or planning pregnancy/fatherhood during study and 180 days after last dose
- Active uncontrolled infection requiring systemic therapy
- Immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 7 days before treatment
AI-Screening
AI-Powered Screening
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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
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