Active — Not RecruitingPhase 2

Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer

Spain46 participantsStarted 2022-11-07

Plain-language summary

This is a multicenter, open-label, non-randomized, single arm, 2 parts, phase II clinical trial evaluating the efficacy and safety of pembrolizumab and lenvatinib plus standard of care chemotherapy (with carboplatin and etoposide ) in subjects with histologically confirmed extensive-stage small-cell lung cancer who have not previously received systemic therapy for this malignancy.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- 1. Histologically or cytologically documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration. Note: Subjects who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample. Mixed tumors are not eligible. * 2\. ES-SCLC, stage IV disease by the American Joint Committee on Cancer, 8th Edition criteria (70), \[T any, N any, M1a, M1b, M1c\], or T3-4 due to multiple lung nodules that are too extensive or tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. * 3\. Have at least one lesion that meets criteria for being measurable, as defined by RECIST 1.1. * 4\. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for biomarker assessment. * 5\. Be male or female ≥18 years of age inclusive, on the day of signing informed consent. * 6\. Have a life expectancy of at least 3 months from the study start. * 7\. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days prior to the first dose of study intervention. * 8\. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of lenvatinib placebo and up to 180 days after the last dose of chemotherapeutic agents: * Refrain from donating sperm P…

What they're measuring

Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of lenvatinib 8 mg to be used in combination with pembrolizumab plus chemotherapy

Timeframe: From the subject's written consent to participate in the study through 90 days after the final administration of the drug

Part 2:To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS)

Timeframe: From the date of the end of induction treatment until 12 months

Trial details

NCT IDNCT05384015

SponsorFundación GECP

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-30

View on ClinicalTrials.gov More Small Cell Lung Cancer Extensive Stage trials