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New treatment option for Small Cell Lung Cancer
Official title MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05903092
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer.
Also referred to as Imfinzi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. Note: HIPAA authorization may be...
- Age ≥ 18 years at the time of consent.
- Demonstrate adequate organ function. All screening labs to be obtained within 28 days prior to registration.
- Absolute Neutrophil Count (ANC) \> 1500mm\^3
You likely can't join 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...
- 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...
See the full eligibility criteria
Who can join
- General
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. Note: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- Demonstrate adequate organ function. All screening labs to be obtained within 28 days prior to registration.
- 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); people with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology)...
- 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
- Females of childbearing potential must have a negative serum pregnancy test at screening.
- Females of childbearing potential and male people must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception.
- Life expectancy of ≥ 12 weeks.
- 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...
- Histologically or cytologically confirmed diagnosis of small cell lung cancer: \- Extensive disease (American Joint Committee on Cancer Stage (8th edition) IV SCLC [T any, N any, M1 a/b]), OR T3-4 disease due to...
- No prior systemic therapy for small-cell lung cancer, with the following exceptions: Up to one cycle of platinum doublet chemotherapy with or without durvalumab is allowed up to 4 weeks prior to registration on this...
- Measurable disease according to RECIST v1.1.
- people with treated brain metastasis or untreated asymptomatic brain metastasis that is clinically stable per investigator discretion and not requiring systemic steroids for ≥ 7 days. NOTE: Prophylactic cranial...
- ECOG Performance Status of 0-2. Limited Stage Specific
- Histologically or cytologically confirmed diagnosis of small cell lung cancer: \- Limited-stage disease (American Joint Committee on Cancer Stage (8th edition) I-III SCLC [T any, N any, M0])
- Has received platinum (cis- or carboplatin) and etoposide chemotherapy (4 cycles preferred; 3 cycles allowed if disease control is achieved and no additional benefit is expected with an additional cycle of chemotherapy...
- Non-progressive disease following completion of chemo-radiation.
- No evidence of brain metastasis. NOTE: PCI is allowed per investigator's discretion.
- Ability to start study treatment within 56 days of completing chemo-radiation, counting from whichever ends later
- ECOG Performance Status of 0-1.
What rules you out
- 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...
- 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...
- 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: people, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last...
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- 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 how well it works assessment of the investigational regimen, per investigator...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Detroit, Michigan, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Iowa City, Iowa, United States; Detroit, Michigan, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.