Study on Durvalumab and Lurbinectedin for Treating Relapsed or Resistant Small Cell Lung Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04607954

Provider View

This clinical trial is exploring the effects of combining durvalumab and lurbinectedin to treat patients with small cell lung cancer that has returned or not responded to previous treatments. The study aims to see if this combination can help control the cancer and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is testing whether the combination of durvalumab, a monoclonal antibody, and lurbinectedin, a cancer-fighting drug, can help treat patients with extensive stage small cell lung cancer that has come back or not responded to previous treatments. Durvalumab may help stop cancer cells from growing and spreading, while lurbinectedin works by slowing or stopping the growth of cancer cells. The goal is to see if this combination can kill more cancer cells and help patients live longer.

Description

The main goal of this study is to see if combining durvalumab with lurbinectedin can help patients with extensive stage small cell lung cancer live longer without the cancer getting worse for at least six months. This is for patients whose cancer has returned or not responded after initial treatment with chemotherapy and immunotherapy.

The study will also look at the safety of the treatment and any side effects that patients experience. Researchers will also assess how well the treatment works by looking at overall survival, how long patients live without the cancer getting worse, and the response rate to the treatment.

Patients in the study will receive durvalumab and lurbinectedin through an IV on the first day of each 21-day cycle. This will continue as long as the cancer does not progress and the side effects are manageable.

After finishing the study treatment, patients whose cancer has not progressed will have follow-up visits 30 days after treatment, every 6 weeks until the cancer progresses, and then every 3 months for up to 5 years. Patients whose cancer progresses will have follow-up visits every 3 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of small cell lung cancer.
  • Cancer must have returned or not responded after one prior treatment with chemotherapy and a PD-1 or PD-L1 inhibitor.
  • Must have received a specific prior treatment regimen including etoposide and a platinum drug with a PD-1 or PD-L1 inhibitor.
  • Must have measurable cancer.
  • Must weigh more than 30 kg.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate blood counts and organ function as determined by specific tests.
  • Must not be pregnant and must agree to use effective contraception during and after treatment.
  • Must have a life expectancy of at least 12 weeks.
  • Must be willing to provide blood and tissue samples for research.
  • Must be willing to return to the study site for follow-up visits.

Exclusion Criteria

  • Cannot be pregnant or breastfeeding.
  • Cannot have received certain treatments, such as live vaccines, surgery, chemotherapy, radiation, or investigational therapies, within a specified time before joining the study.
  • Cannot have unresolved side effects from previous treatments.
  • Cannot have active brain metastases unless they meet specific conditions.
  • Cannot have certain serious health conditions, such as active infections, autoimmune diseases requiring treatment, or uncontrolled illnesses.
  • Cannot have a history of severe allergic reactions to durvalumab or similar drugs.
  • Cannot have had another active cancer within 6 months before joining the study, with some exceptions.

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