Actively Recruiting
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Led by Hirva Mamdani · Updated on 2026-04-29
84
Participants Needed
4
Research Sites
370 weeks
Total Duration
On this page
Sponsors
H
Hirva Mamdani
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Be 18 years or older at consent
- Have adequate organ function including ANC > 1500/mm3, hemoglobin 9 g/dL, platelet count 100,000/mm3, creatinine clearance 40 mL/min, bilirubin 1.5x upper limit of normal (ULN) or approved Gilbert's syndrome, AST and ALT 2.5x ULN (or 5x ULN if liver metastases present)
- Females of childbearing potential must have a negative serum pregnancy test
- Females of childbearing potential and males must agree to use effective contraception or abstain from heterosexual intercourse
- Have life expectancy of at least 12 weeks
- For patients with hepatitis B or C infections, must have undetectable viral load or be cured per protocol
- Extensive-stage cohort: confirmed diagnosis of extensive-stage SCLC with measurable disease, no prior systemic therapy except up to one cycle of platinum doublet chemotherapy (with or without durvalumab), ECOG 0-2, treated or stable brain metastases allowed
- Limited-stage cohort: confirmed limited-stage SCLC diagnosis, completed chemo-radiation with platinum and etoposide, non-progressive disease, no brain metastases, able to start study treatment within 56 days of chemo-radiation completion, ECOG 0-1
You will not qualify if you...
- Body weight 40 kg or less
- Active infection requiring IV antibiotics
- Allergy or hypersensitivity to study drugs or excipients
- Major surgery within 28 days before starting study treatment (except local palliative surgery)
- History of active primary immunodeficiency
- Known HIV positivity or active tuberculosis infection
- Neurologic paraneoplastic syndrome
- Active or prior autoimmune or inflammatory disorders except specified stable or controlled conditions
- Live attenuated vaccine within 30 days before study treatment or during treatment plus 30 days after last dose
- Uncontrolled illnesses including heart failure, hypertension, unstable angina, arrhythmia, interstitial lung disease, serious GI conditions, psychiatric illness limiting compliance
- Pregnant or breastfeeding
- Prior or concurrent malignancy interfering with study assessment
- History of leptomeningeal carcinomatosis
- History of allogeneic organ transplant
- Use of investigational drugs within 28 days or concurrent enrollment in other non-observational studies
- Use of immunosuppressive medications within 7 days before starting study drugs except allowed exceptions
- For extensive-stage cohort, prior durvalumab dose with certain immune-related adverse events or toxicities prohibiting continued immunotherapy
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
Karmanos Cancer Center (Wayne State University)
Detroit, Michigan, United States, 48201
Actively Recruiting
4
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
H
Hirva Mamdani, MD
CONTACT
A
Allison Lipps
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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