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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)

Research & Trial Information

SCHEMA EA5161

Protocol #: EA5161

Cancer Type: Small Cell Lung Cancer

Eligibility Criteria:

  1. Age 18 years.
  2. Patients must have histologically or cytologically confirmed extensive stage small cell lung cancer and must be a candidate for systemic therapy NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage. Limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes. Extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy. Patients with locally recurrent SCLC who are not eligible for curative intent chemoradiation are eligible.
  3. Patients must have measurable disease.
  4. ECOG performance status 0 or 1.
  5. Patients are eligible if CNS metastases are adequately treated and neurological symptoms have returned to baseline or are controlled for at least 2 weeks prior to enrollment.
  6. Patients cannot have had prior chemotherapy or biologic therapy for extensive stage 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.
  7. 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.
  8. Patients may not be receiving any other investigational agents while on study.
  9. Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or other agents used in the study.
  10. No prior or current invasive malignancy (except non-melanomatous skin cancer, localized bladder and prostate cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  11. No prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
  12. Patient must not have leptomeningeal disease.
  13. No patients with an active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes including but not limited to myasthenia gravis, Lambert-Eaton myasthenic syndrome, limbic encephalitis, myositis, Guillain-Barré. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  14. No patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 7 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  15. No patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
  16. Patients must NOT have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  17. HIV-positive patients on combination antiretroviral therapy are ineligible.
  18. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, patients are excluded.
  19. Patients are ineligible if administration of a live, attenuated vaccine within 4 weeks before randomization.
  20. No history of severe hypersensitivity reaction to any monoclonal antibody or allergy to study drug components.

 

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