Chemoradiation w/o Atezo in Limited Stage Small Cell Lung Cancer

September 24, 2019

LIMITED STAGE SMALL CELL LUNG CANCER (LS-SCLC): A PHASE II/III RANDOMIZED STUDY OF CHEMORADIATION VERSUS CHEMORADIATION PLUS ATEZOLIZUMAB

  • Clinical Trial Information

    Trial Contact: Manchola-Orozco, Carolina; Marchese, Sean N

    Trial Phone: 321.841.7293 ; 321.841.4348

  • IRB No: NRG LU005

    Protocol Abbrev: NRG-LU005

    Principal Investigator: Justin Mathew Rineer, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: NRG-LU005

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03811002

  • Objective

    Phase II:
    To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab.
    Phase III:
    To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/- atezolizumab.

  • Key Eligibility

    •  Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N1-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration
    •  Patients must have received one cycle of platinum/etoposide chemotherapy prior to study registration, with study registration required within 21 days from day 1 of first cycle of chemotherapy and protocol treatment designed to begin 21 days after initiation of cycle 1. If patient has not recovered from cycle 1 chemotherapy toxicities, then an additional 14 days is permitted
    •  Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy

    •  Minimal staging requirements include:
    ◦History/physical examination within 30 days prior to registration
    ◦Positron emission tomography (PET)/computed tomography (CT) scan for staging within 45 days prior to registration
    ◦CT chest/abdomen with IV contrast (unless contraindicated based on kidney function) within 30 days prior to registration - this can be obtained as part of PET/CT if CT imaging is of diagnostic quality
    ◦Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration

    •  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration
    •  Absolute neutrophil count (ANC)/granulocytes >= 1, 500/cells/mm^3 (pre-cycle 1)
    •  Platelet count >= 100,000 cells/mm^3 (pre-cycle 1)
    •  Hemoglobin >= 9 g/dL (pre-cycle 1)
    •  Total bilirubin =< 1.5 x upper limit of normal (ULN) (pre-cycle 1)
    •  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 x ULN (pre-cycle 1)
    •  Serum creatinine =< 1.5 x ULN OR calculated creatinine clearance >= 60 ml/min (for carboplatin: creatinine clearance [CrCl] >= 50 by Cockcroft-Gault) (pre-cycle 1)
    •  Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging
    •  Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential
    •  The patient or a legally authorized representative must provide study-specific informed consent prior to study entry