NCT05903092
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentHirva MamdaniInvestigator-initiated
~84 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:DurvalumabMonalizumabCarboplatin or CisplatinEtoposide
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1 year Progression Free Survival (PFS)
Measured over 1 year
+1 more outcome measured
Conditions
Where it's being run
4 sites across 4 statesIndiana1
Iowa1
Michigan1
Virginia1
Study leadership
- Hirva Mamdani, MD · PRINCIPAL_INVESTIGATOR · Wayne State University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Absolute Neutrophil Count (ANC) \> 1500mm\^3
Hemoglobin ≥ 9 g/dL
Platelet Count (PLT) ≥ 100,000 per mm3
Calculated creatinine clearance ≥ 40 mL/min
Bilirubin ≤ 1.5 × upper limit of normal (ULN); subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), may be allowed with sponsor-investigator approval.
Apsartate aminotransferase (AST) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
Alanine aminotransferase (ALT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN 4. Females of childbearing potential must have a negative serum pregnancy test at screening. 5. Females of childbearing potential and male subjects must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception. 6. Life expectancy of ≥ 12 weeks. 7. Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable through PCR to be eligible for this trial. Testing is not required for screening unless mandated by local authorities. Local guidelines for testing should be followed.
Exclusion
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 9. 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. 10. 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. 11. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). 12. 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. 13. History of leptomeningeal carcinomatosis. 14. History of allogeneic organ transplantation. 15. Treatment with any investigational drug within 28 days prior to registration or concurrent enrolment in another clinical study, unless observational in nature. 16. 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. 17. Specific for MOZART-ES cohort: Patients who have received prior one dose of durvalumab along with chemotherapy:
Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE and not currently require maintenance doses of \> 10 mg prednisone or equivalent per day.
What this trial measures
- 1 year Progression Free Survival (PFS)1 year
PFS is defined as the time from Day 1 of treatment until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause.
- Safety and Tolerability24 Months
Safety and tolerability for the extensive stage cohort will be assessed by the grading of adverse events based on Common Toxicity Criteria for Adverse Events (CTCAE) v5.