Testing the addition of a new immunotherapy drug, Atezolizumab (MPDL3280A), to the usual chemoradiation (CRT) therapy treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)

Investigating Immunotherapy in Small Cell Lung Cancer Treatment

Recruiting
18 years - 100 years
All
Phase 2/3
10 participants needed
1 Location

Brief description of study.

This study is being done to answer the following question: Can we lower the chance of small cell lung cancer growing or spreading by adding an immunotherapy drug (atezolizumab) to the usual treatment for this type of cancer?

Detailed description of study

Participants will be randomly assigned to receive chemotherapy and radiation (called chemoradiation therapy or CRT) for up to 7 weeks, or to receive usual CRT for up to 7 weeks plus the study drug, atezolizumab, for up to one year.

All participants will be monitored for side effects during treatment. The doctor will follow up every 3 months for 2 years after treatment, every 6 months for the next 3 years, and annually after this 5 year period.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Limited Stage Small Cell Lung Cancer (LS-SCLC)
  • Age: 18 years - 100 years
  • Gender: All

Individuals at least 18 years of age with limited stage small cell lung cancer (LS-SCLC).

Individuals with surgical resection of small cell lung cancer, prior invasive malignancy, or evidence of metastatic disease will not be eligible.

Individuals with certain co-morbidities, or history of allogeneic organ transplant or immunodeficiency will not be eligible.

Women who are pregnant will not be eligible.

Updated on 19 Feb 2024. Study ID: 2003995198

This study investigates whether adding an investigational immunotherapy medication to the usual treatment can reduce the chance of small cell lung cancer growing or spreading. Small cell lung cancer is a type of cancer that starts in the lungs and can quickly spread to other parts of the body. The study involves participants receiving standard treatment, known as chemoradiation therapy, with or without the investigational medication.

Participants will be randomly assigned to one of two study arms. One arm will receive the standard chemoradiation therapy for up to 7 weeks, while the other arm will receive the same therapy plus the investigational medication for up to one year. All participants will be monitored for side effects during the treatment period. Additionally, doctors will conduct regular follow-ups to monitor the participants' health after the treatment.

  • Who can participate: Individuals at least 18 years old with limited stage small cell lung cancer can participate. Those with previous surgical resection, prior invasive malignancy, metastatic disease, certain co-morbidities, organ transplant history, immunodeficiency, or who are pregnant are excluded.
  • Study details: Participants will receive standard chemoradiation therapy, with or without an investigational immunotherapy medication. A placebo is not used.
  • Study Timelines: The study will last one year.

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