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Protocol No. NRGLU005

Principal Investigator Baschnagel, Andrew

Phase II/III

Age Group Adult

Scope National

Sponsor Type National

Title Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Objective
This study is being done to answer the following question: Can we lower the chance of small cell lung cancer growing or spreading by adding an immunotherapy drug (atezolizumab) to the usual treatment for this type of cancer?
We are doing this study to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for small cell lung cancer

Treatment
Arm 1: Standard CRT (45 Gy bid or 66 Gy daily) plus platinum/etoposide chemotherapy (cisplatin preferred) given every 3 weeks for 3 cycles (for a total of 4 cycles of chemotherapy that includes the cycle given prior to registration). Radiation must start within +/- 2 business days of protocol chemotherapy
Arm 2: Standard CRT (45 Gy bid or 66 Gy daily) plus platinum/etoposide chemotherapy (cisplatin preferred) given every 3 weeks for 3 cycles (for a total of 4 cycles of chemotherapy that includes the cycle given prior to registration) plus concurrent atezolizumab, 1200 mg IV every 3 weeks x 1 year. Radiation must start within +/- 2 business days of protocol chemotherapy

Description A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab for Limited Stage Small Cell Lung Cancer

Key Eligibility
  • Can not be pregnant or breast feeding, male and female of child bearing potential must agree to adequate birth control as defined by the protocol
  • Submission of tumor tissue is required for all patients
  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, AJCC Staging)
  • Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted
  • Patients must have had measurable disease (per RECIST, version 1.1) prior to the required pre-registration cycle of platinum/etoposide chemotherapy
  • Age 18 years or older
  • ECOG performance status 0-2
  • Adequate hematologic, renal and hepatic function as defined by the protocol
  • 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
    EXCLUSION:
  • Definitive clinical or radiologic evidence of metastatic disease
  • Definitive surgical resection of small cell lung cancer
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study PIs
  • Patients with cytologically positive pleural or pericardial fluid
  • An active, known or suspected autoimmune disease
  • Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
  • History of allogeneic organ transplant
  • History of primary immunodeficiency
  • Severe, active co-morbidity defined as follows: liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease, active tuberculosis; active hepatitis B (chronic or acute) or hepatitis C infection; known immunosuppressive disease, for example history of bone marrow transplant or CLL; COPD requiring chronic oral steroid therapy of greater than 10 mg prednisone daily; unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months; transmural myocardial infarction within the last 3 months; clinically significant interstitial lung disease

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions DN Greenwald Center; Oconomowoc Memorial Hospital, Waukesha Memorial; UW Cancer Center at ProHealth; UW Hospital and Clinics; Waukesha Memorial Hosp