MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Recruiting now · Phase 2
Conditions studied: Small Cell Lung Cancer, SCLC, Extensive Stage Small Cell Lung Cancer, Limited Stage Small-Cell Lung Cancer
In brief
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 facts
- Study ID
- NCT05903092
- Run by
- Hirva Mamdani
- People needed
- 84
- Starts
- 2023-09-26
- Expected to finish
- 2030-10-31
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Body weight ≤ 40 kg.
- Active infection requiring intravenous antibiotic therapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.
- History of active primary immunodeficiency.
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
- Presence of neurologic paraneoplastic syndrome.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., ulcerative colitis or Crohn's disease], systemic lupus erythematosus, sarcoidosis, Wegener syndrome [granulomatosis with polyangiitis], rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 2 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. NOTE: Subjects, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per investigator discretion.
- History of leptomeningeal carcinomatosis.
- History of allogeneic organ transplantation.
- Treatment with any investigational drug within 28 days prior to registration or concurrent enrolment in another clinical study, unless observational in nature.
- Current or prior use of immunosuppressive medication within 7 days before the first dose of monalizumab and durvalumab (applicable to 'on study' durvalumab for MOZART-ES cohort who may have received prior one dose of durvalumab). The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication), and for prevention of chemotherapy induced nausea/vomiting per institutional standards.
- Specific for MOZART-ES cohort: Patients who have received prior one dose of durvalumab along with chemotherapy:
Where it is running
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)
- Karmanos Cancer Center (Wayne State University) — Detroit, Michigan, United States (enrolling)
- University of Virginia Health System — Charlottesville, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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