Study on Lurbinectedin and Berzosertib for Small Cell and High-Grade Neuroendocrine Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04802174

Provider View

This clinical trial is exploring whether a combination of two drugs, lurbinectedin and berzosertib, can effectively shrink tumors in patients with small cell lung cancer (SCLC) and high-grade neuroendocrine cancers (HGNEC). The study also aims to find the best dose for this combination treatment.

Patient Parameters

Program Overview

The study is focused on small cell lung cancer (SCLC) and high-grade neuroendocrine cancers (HGNEC), which are aggressive cancers that initially respond to chemotherapy but often return and become resistant to treatment. Researchers are testing a combination of two drugs, lurbinectedin and berzosertib, to see if they can help shrink these tumors and determine the best dose for this treatment.

Description

This clinical trial is investigating a new treatment approach for small cell lung cancer (SCLC) and high-grade neuroendocrine cancers (HGNEC), which are known for their aggressive nature and quick relapse after initial treatment. The study involves two drugs: lurbinectedin, which is already used for SCLC, and berzosertib, a drug that targets a specific protein involved in cancer cell growth.

The trial is divided into two phases. Phase I aims to find the highest dose of the drug combination that patients can tolerate without severe side effects. Phase II will assess how effective the combination is at shrinking tumors in patients who have already received other treatments.

Participants will receive lurbinectedin on the first day of each 21-day cycle and berzosertib on the first and second days. They will continue treatment as long as it is beneficial. Throughout the study, participants will undergo regular health checks, including physical exams, blood tests, heart function tests, and CT scans to monitor the treatment's effectiveness.

Participants will also provide blood and hair samples for research purposes and may have optional tumor biopsies. After completing the treatment, participants will have a follow-up visit and will be monitored through email or phone for the rest of their lives.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have measurable cancer based on standard criteria, or evaluable but not measurable disease for Phase I.
  • Have adequate organ function, including:
    • Hemoglobin level of at least 9.0 g/dL.
    • Neutrophil count of at least 1.5x10(9)/L.
    • Platelet count of at least 100x10(9)/L.
    • Total bilirubin level of 2.0 mg/dL or lower.
    • Liver enzymes within specified limits.
    • Creatinine level of 1.5 mg/dL or lower, or creatinine clearance of at least 60 mL/min.
  • Ability to understand and sign a written informed consent.
  • Agree to use effective contraception during the study and for a specified period after the last dose.

Phase I:

  • Have advanced solid cancers confirmed by lab tests.
  • Have received at least one prior chemotherapy treatment.

Phase II:

  • Have confirmed small cell lung cancer (SCLC) or high-grade neuroendocrine cancer (HGNEC).

Exclusion Criteria

  • Have a tumor that can be potentially cured with other treatments.
  • Currently taking other investigational drugs.
  • Have received chemotherapy or major surgery within the last 2 weeks, or radiotherapy within the last 24 hours.
  • Have a history of severe allergic reactions to similar drugs.
  • Have untreated or symptomatic brain metastases, unless stable and not requiring steroids.
  • Require medications that strongly affect liver enzymes during the study.
  • Have severe or uncontrolled medical conditions, such as active infections, immune deficiencies, uncontrolled diabetes, heart problems, or recent stroke.
  • Are HIV-positive.
  • Are pregnant or breastfeeding.

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