Chemotherapy + Nivolumab for Small Cell Lung Cancer
Trial Summary
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or certain immunosuppressive medications, and you must not have received a live vaccine within 4 weeks before joining the trial.
What data supports the effectiveness of the drug combination of chemotherapy and Nivolumab for small cell lung cancer?
Research shows that combinations of platinum drugs like cisplatin or carboplatin with etoposide are standard treatments for small cell lung cancer, leading to median survival times of 7 to 20 months depending on the stage. These combinations have been shown to be effective, although they can have significant side effects.12345
Is the combination of chemotherapy drugs and Nivolumab safe for treating small cell lung cancer?
How is the drug combination of chemotherapy and Nivolumab unique for small cell lung cancer?
This treatment combines standard chemotherapy drugs like carboplatin, cisplatin, and etoposide with Nivolumab, an immunotherapy drug that helps the immune system attack cancer cells, offering a novel approach by potentially enhancing the body's immune response against small cell lung cancer.12101112
What is the purpose of this trial?
This trial is testing whether adding nivolumab to standard chemotherapy improves treatment for patients with extensive stage small cell lung cancer. The chemotherapy drugs kill or stop the growth of cancer cells, while nivolumab helps the immune system attack the cancer. Nivolumab is an immunotherapy drug that has shown promise in treating various cancers, including non-small cell lung cancer and melanoma.
Research Team
Ticiana A Leal
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
This trial is for adults with extensive stage small cell lung cancer who haven't had prior treatment. They must have normal organ and marrow function, no severe allergies to monoclonal antibodies or study drugs, and not be on other investigational agents. Women of childbearing age and sexually active men must use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive cisplatin/carboplatin and etoposide with or without nivolumab. Treatment repeats every 21 days for up to 4 cycles.
Maintenance
Patients in Arm A continue to receive nivolumab every 2 weeks for up to 2 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up every 3 months if less than 2 years from registration, every 6 months for years 2-3, and yearly up to 5 years.
Treatment Details
Interventions
- Carboplatin
- Cisplatin
- Etoposide
- Nivolumab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor