EA5161

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

Primary Objective:

• To evaluate the progression-free survival (PFS) of patients with extensive stage small cell lung cancer (ED-SCLC) treated with cisplatin/carboplatin and etoposide (CE) or CE with nivolumab (CEN) as frontline treatment.

Secondary Objectives:

• To estimate overall survival of patients with ED-SCLC treated with cisplatin/carboplatin and etoposide (CE) or CE with nivolumab (CEN) as front-line treatment.
• To assess best overall response rate after treatment with CE with or without nivolumab as first line treatment.
• To evaluate the toxicity profile of nivolumab with CE.

Study Arms

• Experimental: Arm A (nivolumab, CE)
• Active Comparator: Arm B (CE)

Eligibility

• 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Absolute neutrophil count >= 1,500/mm^3 must be obtained =< 7 days prior to protocol registration
• Platelets >= 100,000/mm^3 must be obtained =< 7 days prior to protocol registration
• Leukocytes >= 3000/mm^3 must be obtained =< 7 days prior to protocol registration
• Hemoglobin >= 9 g/dL must be obtained =< 7 days prior to protocol registration
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dL) must be obtained =< 7 days prior to protocol registration
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 X institutional upper limit of normal (ULN) (=< 5 X if liver function test [LFT] elevations due to known liver metastases) must be obtained =< 7 days prior to protocol registration
• Serum creatinine =< 1.5 x ULN or calculated creatinine clearance > 50 mL/min (using the Cockcroft-Gault formula) must be obtained =< 7 days prior to protocol registration
• Patients are eligible if central nervous system (CNS) metastases are adequately treated and neurological symptoms have returned to baseline or are controlled for at least 2 weeks prior to enrollment; in addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of =< 10 mg daily prednisone (or equivalent); patients with untreated CNS metastases are eligible if they are not symptomatic and the lesions are less than 1 cm in size
• Patients cannot have had prior chemotherapy or biologic therapy for small cell lung cancer for front line treatment; patients receiving prior whole brain radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =< grade 1; a 1-week washout is permitted for palliative radiation (=< 2 weeks of radiotherapy) to non-CNS disease
• Patients who have received prior chemoradiation treatment with chemotherapy regimen including cisplatin or carboplatin/etoposide for limited-stage SCLC are eligible if treated with curative intent at least 6 months since last treatment from diagnosis of extensive-stage SCLC
• Patients may not be receiving any other investigational agents while on study

NCT ID

NCT03382561