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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Hirva Mamdani
Study ID
NCT05903092
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    1500mg IV on Day 1 of every Cycle
  • Monalizumab — DRUG
    1500mg IV on Day 1 of every Cycle
  • Carboplatin or Cisplatin — DRUG
    On Day 1 of Cycles 1-4 by IV: Carboplatin: AUC 5-6 OR Cisplatin: 75-80mg/m\^2
  • Etoposide — DRUG
    80-100mg/m\^2 IV on Days 1-3 of Cycles 1-4

Study Details

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, unacceptable toxicity, decision to stop study treatment, or withdrawal consent, whichever occurs first.

Key Dates

Start date
Sep 26, 2023
Status verified
Apr 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2030

Study Design

Enrollment
84 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Extensive Stage Cohort
    On Day 1 of every Cycle for the first 4 Cycles (Cycle = 21 Days): Durvalumab 1500mg IV, Monalizumab 1500mg IV, Either Carboplatin AUC 5-6 OR Cisplatin 75-80mg/m\^2 On Days 1-3 of every Cycle for the first 4 Cycles: Etoposide 80-100mg/m\^2 On Day 1 of Cycles 5+ (Cycle = 28 Days): Durvalumab 1500mg IV Monalizumab 1500mg IV
  • Experimental: Limited Stage Cohort
    On Day 1 of every Cycle: Durvalumab 1500mg IV, Monalizumab 1500mg IV will be administered, for up to 26 Cycles (Cycle = 28 days).

Primary Outcome Measure

1 year Progression Free Survival (PFS) [ Time Frame: 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Margaret Uhrich, RN
[email protected]
Misty Shields, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
David Akinbo
[email protected]
Muhammad Furqan, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer Center (Wayne State University)DetroitMichigan48201
Hirva Mamdani, MD
[email protected]
313-576-8711
Hirva Mamdani, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Health SystemCharlottesvilleVirginia22908
Lacey Garrett
[email protected]
Ryan Gentzler, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INUniversity of Iowa Hospitals and Clinics· Iowa City, IAKarmanos Cancer Center (Wayne State University)· Detroit, MIUniversity of Virginia Health System· Charlottesville, VA

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