WHO ICTRP trial

A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus…

EUCTR2017-002672-38-ES · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2017-002672-38-ES
Public title 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
Scientific title Open-Label, Randomized Trial of Nivolumab (BMS-936558) plus Pemetrexed/Platinum or Nivolumab plus Ipilimumab (BMS-734016) vs Pemetrexed plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects with Epidermal Growth Factor Receptor (EGFR) Mutation, T790M Negative Who Failed…
Primary sponsor Bristol-Myers Squibb International Corporation
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries France;Taiwan;Hong Kong;Spain;Singapore;Japan;China;Korea, Republic of
Conditions Subjects with EGFR mutation, T790M negative NSCLC who failed first line (1L) EGFR TKI therapy MedDRA version: 20.0 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms…
Interventions Trade Name: Opdivo Product Name: NIVOLUMAB Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor code: BMS-936558-01 Other descriptive…
Registration date Sep 18, 2017
Target size 465
Secondary IDs CA209-722;NCT02864251
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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