Study on Monalizumab and Durvalumab with Chemotherapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer

Sponsor: Hirva Mamdani

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05903092

Provider View

This clinical trial is testing a new combination of drugs, including monalizumab and durvalumab, with chemotherapy for treating extensive stage small cell lung cancer. The study aims to determine if this combination is safe and effective for patients who have not received prior treatment.

Patient Parameters

Program Overview

The study involves a treatment plan where patients receive a combination of chemotherapy drugs (carboplatin or cisplatin, and etoposide) along with two immunotherapy drugs, durvalumab and monalizumab, every three weeks for four cycles. After these cycles, patients will continue with durvalumab and monalizumab every four weeks until the cancer progresses, side effects become unacceptable, or the patient decides to stop. A small group of patients will first test the safety of this treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization to use personal health information.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must have a confirmed diagnosis of small cell lung cancer that is extensive or too large for radiation treatment.
  • Must not have received prior systemic therapy for small cell lung cancer, except for one cycle of chemotherapy with or without durvalumab.
  • Must have measurable disease according to specific criteria.
  • Patients with treated or stable brain metastases are eligible if they do not need steroids for at least 7 days.
  • Must have adequate organ function based on specific blood test results.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must have a life expectancy of at least 12 weeks.
  • Patients with controlled hepatitis B or C infections are eligible.

Exclusion Criteria

  • Weigh 40 kg or less.
  • Have received chest radiation within 6 months before starting the study treatment.
  • Have an active infection requiring IV antibiotics.
  • Have allergies to any study drugs.
  • Have had major surgery within 28 days before starting the study treatment.
  • Have a history of primary immunodeficiency.
  • Have tested positive for HIV or active tuberculosis.
  • Have a neurologic paraneoplastic syndrome.
  • Have active autoimmune or inflammatory disorders, with some exceptions.
  • Have used immunosuppressive medication within 7 days before starting the study treatment, with some exceptions.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have uncontrolled illnesses that could interfere with the study.
  • Have had severe side effects from prior immunotherapy.
  • Are pregnant or breastfeeding.
  • Have another cancer that could interfere with the study.
  • Have a history of leptomeningeal carcinomatosis or organ transplantation.
  • Have taken an investigational drug within 28 days before starting the study.

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