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A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Patients With EGFR Mutation, T790M Negative NSCLC Who Have Failed 1L EGFR TKI Therapy

2016-08-12 08:53:21 | BioPortfolio

Summary

The purpose of this study is to determine whether Nivolumab+ chemotherapy and Nivolumab+Ipilimumab is effective in the treatment of patients with EGFR mutation, T790M negative NSCLC who failed first line (1L) EGFR TKI therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Non-Small-Cell Lung Carcinoma

Intervention

Nivolumab, Ipilimumab, Pemetrexed, Cisplatin, Carboplatin

Status

Not yet recruiting

Source

Bristol-Myers Squibb

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-12T08:53:21-0400

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An Open-Label, Trial of Nivolumab and Nivolumab Plus Ipilimumab Versus Platinum Doublet Chemotherapy in Subjects With Stage IV Non-Small Cell Lung Cancer (NSCLC)

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Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (Ch

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PubMed Articles [23147 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

A number of small lung lesions characterized by small round masses of 2- to 3-mm in diameter. They are usually detected by chest CT scans (COMPUTED TOMOGRAPHY, X-RAY). Such nodules can be associated with metastases of malignancies inside or outside the lung, benign granulomas, or other lesions.

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