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Platinum-based chemotherapy
Monalizumab + Durvalumab + Chemotherapy for Small Cell Lung Cancer (MOZART Trial)
Phase 2
Recruiting
Led By Hirva Mamdani, MD
Research Sponsored by Hirva Mamdani
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential and male subjects must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
MOZART Trial Summary
This trial involves 4 cycles of chemo, durvalumab, and monalizumab, followed by durvalumab & monalizumab maintenance, with a safety lead-in phase.
Who is the study for?
Adults with extensive stage small cell lung cancer who haven't had systemic therapy, except possibly one cycle of chemo. They must be stable if they have brain metastasis and not need steroids for a week. Participants should expect to live at least 12 weeks, have decent physical function (ECOG 0-2), and agree to use contraception. Those with certain other health conditions or treatments are excluded.Check my eligibility
What is being tested?
The trial tests a combination of the drugs durvalumab and monalizumab with platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide in patients with extensive stage small cell lung cancer. After initial treatment cycles, maintenance doses continue until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting various organs, infusion-related reactions, fatigue, digestive issues like diarrhea, blood disorders that can affect cells counts and increase infection risk.
MOZART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to use birth control or abstain from sex.
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My hepatitis B is under control, or I've been cured of hepatitis C.
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I can take care of myself and am up and about more than half of the day.
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My lung cancer is extensive and confirmed by tests.
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I am 18 years old or older.
MOZART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1 year Progression Free Survival (PFS)
Safety and Tolerability
Secondary outcome measures
Intracranial PFS (iPFS)
Objective Response Rate (ORR)
Overall Survival (OS)
MOZART Trial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab + Monalizumab + ChemotherapyExperimental Treatment4 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Etoposide
2010
Completed Phase 3
~2440
Monalizumab
2019
Completed Phase 2
~250
Carboplatin or Cisplatin
2020
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteOTHER
163 Previous Clinical Trials
9,218 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,612,637 Total Patients Enrolled
Hirva MamdaniLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or will have chest radiation before systemic therapy or as consolidation.You have had or currently have another type of cancer that could affect the evaluation of the new treatment.I am willing to use birth control or abstain from sex.I do not have any serious ongoing illnesses that could interfere with the study.You have a medical condition that can be measured using specific guidelines.You have previously taken durvalumab along with chemotherapy and did not have severe side effects, particularly related to the immune system. If you have mild endocrine side effects and are managing them with replacement therapy, you may still be eligible.I haven't had systemic therapy for small-cell lung cancer, except possibly one round of specific chemotherapy.I haven't taken strong immune system drugs recently, except for minor exceptions like inhalers or small doses of steroids.I am currently on IV antibiotics for an infection.My brain metastasis is stable, and I haven't needed steroids for over a week.My hepatitis B is under control, or I've been cured of hepatitis C.You have tested positive for HIV or have an active tuberculosis infection.My organ functions are within normal ranges as per recent tests.I have an autoimmune or inflammatory disorder but it's controlled or I'm exempt based on the listed conditions.You have a history of a serious immune system problem.I can take care of myself and am up and about more than half of the day.I have received an organ transplant from another person.I am capable of becoming pregnant and have a negative pregnancy test.You are expected to live for at least 12 more weeks.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.My body weight is 40 kg or less.I have not received a live vaccine in the last 30 days.I have had cancer spread to the lining of my brain and spinal cord.My lung cancer is extensive and confirmed by tests.I am 18 years old or older.I have a nervous system disorder related to my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab + Monalizumab + Chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment open at the present time?
"Affirmative. The information available on clinicaltrials.gov reveals that the study is currently looking for 38 participants from 1 site and was initially posted on June 30th 2023, with a recent edit being made July 6th of the same year."
Answered by AI
Is the combination of Durvalumab, Monalizumab and Chemotherapy safe for patient use?
"With a score of 2, durvalumab + monalizumab plus chemotherapy has some evidence around safety but no data to confirm its efficacy."
Answered by AI
What is the headcount of participants in this experiment?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was initially opened on June 30th 2023, is currently looking for participants. A total of 38 individuals need to be recruited from 1 site."
Answered by AI
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