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Small Cell Lung CancerPhase 2MOZARTNCT05903092

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

A Phase 2 study testing Durvalumab, Monalizumab and Carboplatin or Cisplatin in people with Small Cell Lung Cancer and SCLC, run by Khalil Choucair at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab, Monalizumab and Carboplatin or Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
4 sitesUnited States
Study dates
26 Sep 2023to 31 Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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).
Show all 28Show fewer
  • 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:
  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Khalil Choucair, MD, MSc contact

313-576-8315

choucairk@karmanos.org

Allison Lipps contact

317-634-5842 ext. 40

alipps@hoosiercancer.org

United States4 sites, 4 recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

    Lacey Garrett, lb5tu@uvahealth.org

    Ryan Gentzler, MD

    Recruiting

  • Karmanos Cancer Center (Wayne State University)

    Detroit, Michigan, 48201

    Khalil Choucair, MD, MSc, 313-576-8315, choucairk@karmanos.org

    Khalil Choucair, MD, MSc

    Recruiting

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Margaret Uhrich, RN, muhrich@iu.edu

    Misty Shields, MD, PhD

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    David Akinbo, david-akinbo@uiowa.edu

    Muhammad Furqan, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) for tReatmenT of Small Cell Lung Cancer (MOZART)

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.

Being tested
Durvalumab, Monalizumab, Carboplatin or Cisplatin, Etoposide
Keywords
Small cell lung cancer, First-line therapy, Chemoimmunotherapy, Immunotherapy, Monalizumab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called Imfinzi

    1500mg IV on Day 1 of every Cycle

  • MonalizumabDrug

    1500mg IV on Day 1 of every Cycle

  • Carboplatin or CisplatinDrug

    On Day 1 of Cycles 1-4 by IV:

    Carboplatin: AUC 5-6 OR Cisplatin: 75-80mg/m^2

  • EtoposideDrug

    Also called VP-16

    80-100mg/m^2 IV on Days 1-3 of Cycles 1-4

Study groups in NCT05903092
Study groupRoleWhat they receive
Extensive Stage CohortExperimentalOn 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
Receives: Drug: Durvalumab; Drug: Monalizumab; Drug: Carboplatin or Cisplatin; Drug: Etoposide
Limited Stage CohortExperimentalOn Day 1 of every Cycle: Durvalumab 1500mg IV, Monalizumab 1500mg IV will be administered, for up to 26 Cycles (Cycle = 28 days).
Receives: Drug: Durvalumab; Drug: Monalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 year Progression Free Survival (PFS)

    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.

    Measured: 1 year

  2. Safety and Tolerability

    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.

    Measured: 24 Months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    The objective response rate for the extensive stage cohort is the proportion of all subjects with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment)

    Measured: 24 Months

  2. Safety and Tolerability

    Safety and tolerability for the limited stage cohort will be assessed by the grading of adverse events based on Common Toxicity Criteria for Adverse Events (CTCAE) v5.

    Measured: 24 Months

  3. 1 Year Overall Survival (OS)

    OS is defined as the time from Day 1 of treatment until death as a result of any cause.

    Measured: 24 Months

  4. Intracranial PFS (iPFS)

    iPFS is defined as the time from Day 1 of treatment until the criteria for intracranial disease progression is met as defined by RECIST 1.1 or administration of brain radiation or death as a result of any cause, whichever comes first.

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start26 Sep 2023
  3. Primary completion31 Oct 2029 (estimated)
  4. Study completion31 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05903092
Sponsor's protocol ID
HCRN LUN21-530
Acronym
MOZART
Status last verified
Nov 2026
First submitted
5 Jun 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, Monalizumab and Carboplatin or Cisplatin in people with Small Cell Lung Cancer and SCLC, run by Khalil Choucair at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Khalil Choucair, MD, MSc (313-576-8315, choucairk@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 year Progression Free Survival (PFS) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05903092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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