Study on Lamivudine Combined with Chemoimmunotherapy for Treating Extensive Stage Small Cell Lung Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04696575

Provider View

This clinical trial is exploring whether adding the drug lamivudine to the standard chemotherapy and immunotherapy treatment can help control extensive stage small cell lung cancer (ES-SCLC) more effectively. The study aims to see if this combination can prevent the cancer from growing and spreading.

Patient Parameters

Program Overview

This study is testing if the drug lamivudine, when combined with standard chemotherapy and immunotherapy, can help treat extensive stage small cell lung cancer (ES-SCLC). While initial treatments for this type of cancer often work well, the cancer can become resistant over time. Lamivudine is an antiviral drug that might help prevent this resistance. The chemotherapy drugs carboplatin and etoposide work by stopping cancer cells from growing and spreading, while the immunotherapy drug atezolizumab helps the immune system attack the cancer. By adding lamivudine to these treatments, researchers hope to improve their effectiveness.

Description

The main goal of this study is to see if adding lamivudine to standard chemotherapy can help patients with extensive stage small cell lung cancer (ES-SCLC) live longer without the cancer getting worse over six months. Researchers will also look at how well patients do over a year and check for any side effects from the treatment.

Treatment Plan:

  • Induction Phase: Patients will take lamivudine by mouth every day for 28 days. They will also receive carboplatin and atezolizumab through an IV on the first day, and etoposide through an IV on days 1 to 3. This cycle repeats every 28 days for up to 4 cycles, as long as the cancer does not progress and side effects are manageable.
  • Maintenance Phase: Patients will continue taking lamivudine daily and receive atezolizumab through an IV on the first day of each 28-day cycle, as long as the cancer does not progress and side effects are manageable.

Patients who cannot take atezolizumab or choose not to can still participate in the study with carboplatin and etoposide, along with lamivudine.

After finishing the study treatment, patients will have follow-up visits 30 days later and then every 60 days.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good overall health status, able to carry out light work.
  • Have a confirmed diagnosis of small cell lung cancer (SCLC).
  • Cancer must be extensive stage, meaning it has spread beyond the lungs.
  • Must have measurable cancer based on specific medical criteria.
  • Have adequate blood cell counts and organ function.
  • Newly diagnosed patients can have received no more than one cycle of standard treatment before joining the study.
  • Patients whose cancer has returned can join if they had only one previous treatment with platinum-based chemotherapy and it was at least 12 months ago.
  • Must agree to use effective birth control during the study.
  • Must understand the study and sign a consent form.

Exclusion Criteria

  • Have received cancer treatment within 4 weeks before starting the study, except as allowed.
  • Have untreated or symptomatic brain metastases.
  • Have cancer spread to the brain's lining (leptomeningeal involvement).
  • Participated in another study within 28 days before joining.
  • Had major surgery within 14 days before starting the study.
  • Have immune system diseases like AIDS or other serious infections.
  • Have allergies to the study drugs.
  • Have serious heart conditions or recent heart attacks.
  • Have autoimmune disorders requiring treatment in the past two years, if receiving atezolizumab.

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