Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive… (NCT03382561) | Clinical Trial Compass
CompletedPhase 2
Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer
United States160 participantsStarted 2018-05-21
Plain-language summary
This randomized phase II clinical trial studies whether the addition of nivolumab to cisplatin (or carboplatin) and etoposide will improve outcomes when treating patients with extensive stage small cell lung cancer. Chemotherapy drugs, such as cisplatin, carboplatin, and etoposide, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cisplatin/carboplatin and etoposide together with nivolumab may work better in treating patients with extensive stage small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
* Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Absolute neutrophil count \>= 1,500/mm\^3 (must be obtained =\< 7 days prior to protocol registration)
* Platelets \>= 100,000/mm\^3 (must be obtained =\< 7 days prior to protocol registration)
* Leukocytes \>= 3000/mm\^3 (must be obtained =\< 7 days prior to protocol registration)
* Hemoglobin \>= 9 g/dL (must be obtained =\< 7 days prior to protocol registration)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bil…
What they're measuring
1
Progression-free Survival (PFS)
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months