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OncoMatch/Clinical Trials/NCT05384015

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

Is NCT05384015 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lenvatinib and Pembrolizumab for small cell lung cancer extensive stage.

Phase 2RecruitingFundación GECPNCT05384015Data as of May 2026

Treatment: Lenvatinib · Pembrolizumab · Etoposide · CarboplatinThis 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.

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Disease stage

Required: Stage ES-SCLC, IV, T ANY, N ANY, M1A, T ANY, N ANY, M1B, T ANY, N ANY, M1C, 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 (AJCC 8th Edition)

Metastatic disease required

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.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Has received any prior therapy (chemotherapy, radiotherapy, surgical resection) or other investigational agent for the treatment of SCLC.

Cannot have received: radiotherapy

Has received any prior therapy (chemotherapy, radiotherapy, surgical resection) or other investigational agent for the treatment of SCLC.

Cannot have received: surgical resection

Has received any prior therapy (chemotherapy, radiotherapy, surgical resection) or other investigational agent for the treatment of SCLC.

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy

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 (eg, CTLA-4, OX-40, CD137).

Cannot have received: investigational agent

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.

Cannot have received: allogeneic bone marrow transplantation

Prior allogeneic bone marrow transplantation or solid organ transplant.

Cannot have received: solid organ transplant

Prior allogeneic bone marrow transplantation or solid organ transplant.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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