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Clinical Trial 20348

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03811002

Phase: Phase II/III
Prinicipal Investigator:

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Overview

Study Title

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III randomized study of chemoradiation versus chemoradiation plus Atezolizumab

Summary

This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.

Objective

Primary 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. Secondary Objectives To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. (phase III) To determine overall response rate (ORR), rates of local control, and distant metastases free survival with chemoradiation +/- atezolizumab To characterize immune mediated and non-immune mediated toxicity from chemoradiotherapy plus atezolizumab To compare quality of life, as measured by the FACT-TOI, for patients undergoing chemoradiation +/- atezolizumab To evaluate the quality-adjusted survival, using scores from the EQ-5D-5L, of chemoradiation +/- atezolizumab for patients with LS-SCLC To characterize fatigue, as measured by the PROMIS, following chemoradiation +/- atezolizumab To determine the association of blood based tumor mutational burden (bTMB) and tissue-based tumor mutational burden (tTMB) with clinical outcome

Treatments

Therapies

Medications

Atezolizumab (Tecentriq); Paraplatin (carboplatin); Radiotherapy (); carboplatin (); cisplatin (); etoposide ()

Inclusion Criteria

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer, within 60 days prior to registration
  • Participants 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 Participant has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted
  • Participants 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 45 days prior to registration - this can be obtained as part of PET/CT if CT imaging is of diagnostic quality
  • Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy
  • 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
  • Adequate organ function per protocol
  • Participants 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 Participant or a legally authorized representative must provide study-specific informed consent prior to study entry

  • Exclusion Criteria

  • Definitive clinical or radiologic evidence of metastatic disease
  • Definitive surgical resection of small cell lung cancer
  • 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)
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable
  • Any prior atezolizumab or other immunotherapy agent
  • 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 principal investigators (PIs)
  • Participants with cytologically positive pleural or pericardial fluid are not eligible
  • An active, known or suspected autoimmune disease. Participants are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • 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:
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the Participant at high risk from treatment complications
  • Active tuberculosis
  • Active hepatitis B (chronic or acute) or hepatitis C infection. Note that if hepatitis status is unknown, hepatitis B/C testing is required
  • Participants with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible
  • Participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for Participants who have a positive HCV antibody test.)
  • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL)
  • CD4 count > Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary
  • 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
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease

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