Actively Recruiting
First Line Therapy for Extensive SCLC Patients, Treated with Chemo+Keytruda Followed by Keytuda+Trodelvy
Led by Nir Peled · Updated on 2025-01-17
21
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Induction phase of carboplatin+etoposide+pembrolizumab followed by maintenance of Pembrolizumab+sacituzumab govitecan
CONDITIONS
Official Title
First Line Therapy for Extensive SCLC Patients, Treated with Chemo+Keytruda Followed by Keytuda+Trodelvy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of informed consent
- Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer
- No prior systemic treatment for extensive-stage small cell lung cancer (treatment-naïve for this stage)
- Participants previously treated for limited-stage small cell lung cancer with at least 6 months disease-free survival after treatment completion are allowed
- Recovery to Grade 1 or baseline from adverse events of previous anticancer therapies; endocrine-related adverse events adequately managed or Grade 2 neuropathy allowed
- Written informed consent provided by participant or legal representative
- Measurable disease per RECIST 1.1 criteria; previously irradiated lesions considered if progression shown
- Provided archival tumor tissue or new biopsy of a non-irradiated tumor lesion; asymptomatic brain metastases allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days before first treatment dose
- Life expectancy greater than 3 months
- Adequate organ function based on study-defined laboratory tests within 10 days before treatment start
- Female participants must not be pregnant or breastfeeding and must either not be women of childbearing potential or agree to contraception during treatment and for 120 days after last dose
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Prior systemic anticancer therapy including biologics or investigational agents within 4 weeks before treatment
- Radiotherapy, chemotherapy, or targeted therapy within 2 weeks before treatment without recovery from adverse events (Grade 2 or higher), except limited palliative radiotherapy
- Not recovered from adverse events due to prior agents, except neuropathy or alopecia
- Previous treatment with topoisomerase 1 inhibitors
- Live or live-attenuated vaccine within 30 days before treatment; killed vaccines allowed
- Use of investigational drugs within 28 days or 5 half-lives before treatment
- Known hypersensitivity to study drugs or their components
- Immunodeficiency or chronic immunosuppressive therapy exceeding 10 mg prednisone equivalent within 7 days before treatment
- Active malignancy requiring treatment within 3 years, with exceptions for certain skin and prostate cancers
- Active central nervous system metastases or carcinomatous meningitis unless stable for at least 4 weeks without steroids
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapy
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Active chronic inflammatory bowel disease or recent gastrointestinal perforation
- History or active hepatitis B or C infection
- Incomplete recovery from major surgery or ongoing complications
- Any condition or abnormality interfering with study participation or results
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnancy, breastfeeding, or planning conception during study and 120 days after last treatment
- History of allogenic tissue or solid organ transplant
- History of HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shaare Zedek Medical Center
Jerusalem, Israel, Israel, 9103102
Actively Recruiting
Research Team
N
Nir Peled, MD
CONTACT
E
Einat Levi, Bachelors
CONTACT
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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