Temozolomide and Atezolizumab as Second or Third Line Treatment for Metastatic or Recurrent Small Cell Lung Cancer

Sponsor: Dwight Owen

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04919382

Provider View

This study is testing the effects of combining the chemotherapy drug temozolomide with the immunotherapy drug atezolizumab for patients with small cell lung cancer that has spread or returned after initial treatment. The goal is to see if this combination can help patients live longer.

Patient Parameters

Program Overview

This phase II clinical trial is exploring whether the combination of temozolomide, a chemotherapy drug, and atezolizumab, an immunotherapy drug, can be effective as a second or third line of treatment for patients with small cell lung cancer that has spread to other parts of the body or has come back after previous treatments. Temozolomide works by stopping cancer cells from growing and spreading, while atezolizumab helps the immune system attack cancer cells. The study aims to find out if this combination can help patients live longer and control the cancer better.

Description

The main goal of this study is to see how effective the combination of atezolizumab and temozolomide is for patients with metastatic small cell lung cancer who have not responded to previous treatments. Researchers will also look at the safety and side effects of this treatment combination.

Patients will be divided into two groups:

  • Group 1: Patients will receive atezolizumab through an IV on the first day and take temozolomide pills daily for five days. This cycle will repeat every 28 days as long as the treatment is working and side effects are manageable.

  • Group 2: Patients will receive atezolizumab through an IV on the first day and take temozolomide pills daily for 14 days in the first cycle and for 21 days in the following cycles. This cycle will also repeat every 28 days.

After finishing the treatment, patients will have follow-up visits 30 days later and then every three months to monitor their health and the cancer's response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of extensive stage small cell lung cancer that has spread or returned after initial treatment.
  • Must have received platinum-based chemotherapy with immunotherapy before.
  • Must have measurable cancer according to specific medical criteria.
  • Can have had up to three previous treatments for metastatic cancer.
  • Must have certain blood cell counts and organ function levels within normal ranges.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after treatment.
  • Men must agree to use condoms or abstain from intercourse during and after treatment.
  • Must be able to understand and agree to the study procedures.
  • Must provide a recent tumor tissue sample if available.
  • Must be willing to provide blood samples during the study.
  • Must have a life expectancy of more than three months.
  • Must be able to swallow pills.

Exclusion Criteria

  • Currently participating in another study or have used an investigational drug within four weeks.
  • Have received temozolomide before.
  • Have another cancer that could interfere with the study.
  • Have untreated or symptomatic brain metastases.
  • Have a significant infection or immune deficiency.
  • Have had recent chemotherapy, immunotherapy, or radiation therapy.
  • Have a history of autoimmune disease or immune deficiency.
  • Have significant heart disease or other serious medical conditions.
  • Are pregnant or breastfeeding.
  • Have a history of severe allergic reactions to similar drugs.
  • Have uncontrolled fluid buildup in the body requiring frequent drainage.
  • Have high calcium levels in the blood.

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