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Title:
EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis
Protocol Number:
NCTNEA5163
Phase:
Phase III
Physician:
Julie Brahmer
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Johns Hopkins Bayview Medical Center
Purpose:
This study is being done to answer the following questions:Does starting treatment with the immunotherapy drug, MK-3475 (pembrolizumab), alone, instead of a combination of immunotherapy and chemotherapy, result in a significant improvement in overall survival (OS) (time being alive) for patients with your type of cancer? Does additional treatment with chemotherapy following immunotherapy alone also improve overall survival?We are doing this study because we want to find out whether either of these two usual approaches to treating your type of cancer is better or worse than the other. The usual approach is defined as care most people get for PD-L1 positive non-squamous non-small cell lung cancer.
Eligibility:
Generally health adults with PD-L1 positive non-squamous non-small cell lung cancer may be eligible.
Treatment:
If you decide to take part in this study, you will be randomly assigned to a study group. Depending on your assigned study group, you will either get the immunotherapy drug, MK-3475 (pembrolizumab) alone or a combination of chemotherapy (carboplatin, pemetrexed) and MK-3475 (pembrolizumab) until your disease gets worse, the side effects become too severe, or for up to 2 years of treatment on MK-3475 (pembrolizumab). If you initially received MK-3475 (pembrolizumab) alone and your disease gets worse, you will go on to receive either chemotherapy (carboplatin, pemetrexed) alone or in addition to the immunotherapy (MK-3475/pembrolizumab) until your disease gets worse again, the side effects become too severe, or in the latter case, up to 2 additional years of treatment on MK-3475 (pembrolizumab). In each of the relevant treatment plans mentioned above, you may only receive up to 4 doses of carboplatin (1 dose per cycle/month), but pemetrexed can continue beyond 2 years if it is still working.After you finish your study treatment, your doctor will continue to follow your condition for a total of 5 years from when you began taking part in the study and watch you for side effects. They will check your condition every 3 months after your treatment ends for first 3 years. Afterwards, they will check your condition every 6 months for the final 2 years. This means you will continue to see your doctor for a total of 5 years after you begin taking part in the study.
Population:
Adult
Last Update
08/11/2020 05:02 AM