NCT06667167
Recruiting
Phase 2
A Prospective, Open-label, Single-arm, Phase II Study to Evaluate First Line Therapy for Extensive-stage Small Cell Lung Cancer (SCLC) Patients, Treated by Induction Carboplatin/etoposide/pembrolizumab Followed by Maintenance of Pembrolizumab/ Sacituzumab Govitecan
Nir Peled1 site in 1 country21 target enrollmentStarted: December 24, 2024Last updated:
InterventionsInduction Carboplatin
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Nir Peled
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
Overview
Brief Summary
Induction phase of carboplatin+etoposide+pembrolizumab followed by maintenance of Pembrolizumab+sacituzumab govitecan
Detailed Description
Patients with extensive small cell lung cancer, who are previously untreated for extensive disease, will receive induction chemotherapy of carboplatin and etoposide along with pembrolizumab. The patient will then receive maintenance therapy with pembrolizumab and sacituzumab govitecan.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of ES SCLC will be enrolled in this study.
- •The participant has not been previously treated with systemic therapy for ES SCLC (i.e., the disease is treatment naïve).
- •Note: Participants previously treated for limited SCLC will be allowed with disease-free survival (DFS) of 6 months after completion of all treatment.
- •Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
- •The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. Note: Participants with asymptomatic brain metastases will be eligible. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Evaluation of ECOG is to be performed within 3 days prior to the first dose of study intervention.
Exclusion Criteria
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- •Has received prior systemic anti-cancer therapy including biologic agents or investigational agents or an investigational device within 4 weeks prior to treatment initiation.
- •Has received prior radiotherapy, chemotherapy, or targeted small molecule therapy within 2 weeks of start of study intervention and have not recovered from AEs at the time of study entry (i.e., ≥Grade 2 is considered not recovered), or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system (CNS) disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
- •Have not recovered (i.e., ≥Grade 2 is considered not recovered) from AEs due to a previously administered agent.
- •Note: participants with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study.
- •Have previously received topoisomerase 1 inhibitors.
- •Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. (Refer to Section 5.5 for information on COVID-19 vaccines).
- •Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.
- •Has a known hypersensitivity to any of the study treatments, their metabolites, or formulation excipients.
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Arms & Interventions
Single Arm
Experimental
Single Arm
Intervention: Induction Carboplatin (Drug)
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Hypothesis: The addition of SG to pembrolizumab in the post induction phase of the KEYNOTE-604 regimen will improve PFS of participants with first-line ES SCLC.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nir Peled
Head of Oncology
Shaare Zedek Medical Center
Study Sites (1)
Loading locations...
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