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Protocol No. EA5161

Principal Investigator Leal, Ticiana

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title Randomized Phase II Clinical Trial of Cisplatin/Carboplatin and Etoposide (CE) alone or in Combination with Nivolumab as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ED-SCLC)

Objective The purpose of this research study is to compare any good and bad effects of using nivolumab (OPDIVO®) along with the usual chemotherapy regimen of cisplatin/carboplatin and etoposide to using the usual chemotherapy approach alone. Nivolumab is a drug that may turn on the body’s immune system to attack cancer cells. The addition of nivolumab to the usual chemotherapy could shrink your cancer and could delay it from returning but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug/study approach should improve how long you are able to live with your cancer under control by approximately 3 or more months compared to the usual approach. This study drug, nivolumab, is already FDA-approved for use in a different type of lung cancer called non-small cell lung cancer. It is also used for melanoma, head & neck cancer, kidney cancer, bladder cancer and a certain type of lymphoma but is not approved for the treatment of small cell lung cancer.

Treatment
Group 1 will receive the study drug nivolumab in combination with the usual chemotherapy regimen of platinum (cisplatin or carboplatin) and etoposide administered by an intravenous (IV) infusion
Group 2 will receive the usual chemotherapy alone administered by an intravenous (IV) infusion

Description Phase II trial of Cisplatin/Caboplatin and Etoposide with or without Nivolumab

Key Eligibility
  • Must be 18 years of age or older
  • Patients must have histologically or cytologically confirmed extensive stage small cell lung cancer and must be a candidate for systemic therapy
  • Patients must have measurable disease based on RECIST 1.1
  • ECOG performance status 0 or 1
  • Patients must have acceptable organ and marrow function
  • Patients are eligible if CNS metastases are adequately treated and neurological symptoms have returned to baseline or are controlled for at least 2 weeks prior to enrollment
  • Patients cannot have had prior chemotherapy or biologic therapy for small cell lung cancer for front line treatment
  • Women must not be pregnant or breast-feeding
  • Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must use an accepted and effective method of contraception or abstain from sexual intercourse
  • No prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
  • Patient must not have leptomeningeal disease
  • No patients with an active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes
  • No patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications
  • No patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Nivolumab

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Mercy Health Systems, Janesville ; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park