Study on M7824 and Topotecan or Temozolomide for Treating Relapsed Small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03554473

Provider View

This clinical trial is testing a new treatment approach using M7824 combined with either topotecan or temozolomide to see if it can help patients with small cell lung cancer (SCLC) that has returned after initial treatment.

Patient Parameters

Program Overview

Small cell lung cancer (SCLC) is a fast-growing cancer that often comes back after initial treatment. This study is exploring whether combining a new drug, M7824, with existing chemotherapy drugs, topotecan or temozolomide, can improve treatment outcomes for patients whose cancer has returned. M7824 is designed to help the immune system fight cancer more effectively. The trial aims to see if this combination can shrink tumors in patients with relapsed SCLC.

Description

Small cell lung cancer (SCLC) is a very aggressive type of cancer that often returns after initial treatment. This study is looking at a new treatment option for patients whose SCLC has come back. The treatment involves a drug called M7824, which is designed to help the immune system fight cancer, combined with chemotherapy drugs topotecan or temozolomide. These drugs work by damaging the DNA of cancer cells, which can help stop them from growing.

The study is divided into different groups:

  • Arm A: Patients receive M7824 alone to see how safe it is and how well it works. If the cancer progresses, patients may switch to a combination of M7824 and temozolomide.
  • Arm B: Patients receive M7824 with topotecan in 3-week cycles.
  • Arm C: Patients receive M7824 with temozolomide in 4-week cycles.

The study will monitor the safety and effectiveness of these treatments. Optional tumor biopsies may be taken to help understand how the treatment is working. Patients will be closely observed, especially during the first week of treatment, to ensure safety.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of small cell lung cancer (SCLC) or similar small cell cancers outside the lungs.
  • Cancer must have returned after at least one previous chemotherapy treatment.
  • Must be 18 years or older.
  • Must be in relatively good health, with a performance status score of 2 or less.
  • Must have measurable cancer that can be tracked during the study.
  • Must not have had chemotherapy or major surgery within 2 weeks, or radiation within 24 hours before joining the study.
  • Must have adequate organ function, including specific blood counts and liver and kidney function.
  • Must agree to use effective birth control during the study and for a period after the last dose of the study drug.

Exclusion Criteria

  • Cancer that can be treated with potentially curative therapy.
  • Currently receiving other experimental treatments, except for prior immunotherapy, topotecan, or temozolomide.
  • History of severe allergic reactions to similar drugs.
  • Active brain metastases causing symptoms, unless treated and stable without steroids.
  • Severe or uncontrolled medical conditions, including certain infections, heart problems, or recent strokes.
  • Pregnant or breastfeeding women due to potential risks to the baby.
  • Active autoimmune diseases that could worsen with treatment, except for certain stable conditions.
  • Recent use of immunosuppressive drugs or live vaccines.
  • Unwillingness to accept blood products if needed.
  • Known contraindications for topotecan or temozolomide.

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