Phase II/III Randomized Study of Chemoradiation Vs. Chemoradiation Plus Atezolizumab for Limited Stage Small Cell Lung Cancer

April 17, 2020

Clinical Trial Information

SCHEMA

PROTOCOL: NRG-LU005

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0), within 60 days prior to registration.
  2. 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.
  3. Patients must have had measurable disease.
  4. Age ≥ 18.
  5. ECOG Performance Status of 0-2 within 30 days prior to registration.
  6.   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.
  7.  No definitive clinical or radiologic evidence of metastatic disease.
  8.  No definitive surgical resection of small cell lung cancer.
  9.  No prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all
    permissible).
  10. No more than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment. Note that prior chemotherapy for a different cancer is allowable. No prior Atezolizumab or other immunotherapy agent.
  11.  No 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.
  12. Patients with cytologically positive pleural or pericardial fluid are not eligible.

Genesys Hurley Cancer Institute

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Flint, MI 48503

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Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

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