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Study identifier: NCT05903092 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer

Condition: Small Cell Lung Cancer · SCLC · Extensive Stage Small Cell Lung Cancer  ·  Sponsor: Hirva Mamdani

PhasePhase 2
Planned participants84
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study has 2 cohorts: MOZART-ES cohort (for extensive-stage SCLC) and MOZART-LS cohort (for limited-stage SCLC). MOZART-ES cohort: Study treatment will consist of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide plus durvalumab plus monalizumab every 3 weeks for 4 cycles. After 4 cycles, subjects will continue maintenance treatment with durvalumab plus monalizumab every 4 weeks until disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal of consent. Patients who have received one prior cycle of treatment before enrolling on the study will receive a total of 4 cycles with monalizumab, durvalumab, and chemotherapy. There will be a safety lead-in phase, including 6 to 12 patients, to confirm the safety of the proposed dose of monalizumab to use in combination with chemotherapy and durvalumab. MOZART-LS cohort: Study treatment will consist of durvalumab and monalizumab following standard of care chemo-radiation consisting of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide for 3-4 cycles and standard dose radiation. Radiation therapy should have started before completion of cycle 2 of chemotherapy. NOTE: Subjects who have non-progressive disease and meet the eligibility criteria can start study treatment up to 56 days from completion of chemo-radiation. Durvalumab and monalizumab will be administered every 4 weeks for up to 2 years (26 cycles), disease progression, una…

This description comes directly from the study's public registry record.

Talk to the study team

Hirva Mamdani, MD  ·  313-576-8711  ·  mamdanih@karmanos.org

Allison Lipps  ·  317-634-5842  ·  alipps@hoosiercancer.org

Always discuss trial participation with your own doctor first.

Locations (4)

Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana, United StatesRecruiting
University of Iowa Hospitals and ClinicsIowa City, Iowa, United StatesRecruiting
Karmanos Cancer Center (Wayne State University)Detroit, Michigan, United StatesRecruiting
University of Virginia Health SystemCharlottesville, Virginia, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05903092