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NCT02613507CompletedPhase 3

Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer

An Open-label Randomized Multinational Phase 3 Trial of Nivolumab Versus Docetaxel in Previously Treated Subjects With Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 078: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 078)

Source: ClinicalTrials.gov · Last updated 19 Nov 2024

Brief summary (registry, in English)

The purpose of this study is to determine whether Nivolumab improves life expectancy compared to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have failed prior platinum-based doublet chemotherapy.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
504 (actual)
First submitted
22 Nov 2015
Start date
11 Dec 2015
Primary completion date
15 Sept 2017
Lead sponsor
Bristol-Myers Squibb
Diseases
Lung cancer
NCT number
NCT02613507
EudraCT number
2015-001893-16

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 504
  • From 11 Dec 2015 to the primary completion date, 15 Sept 2017
  • 33 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with Docetaxel
  • Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or checkpoint pathways

Other illness

  • History of Carcinomatous meningitis
  • History of auto immune diseases

Other

  • Active Central nervous system (CNS) metastases

Who the study is looking for

  • Disease progression experienced during or after one prior platinum containing doublet chemotherapy
  • Stage IIIb/IV or recurrent disease
  • Male and Female ≥ 18 years of age
  • Measurable disease per RECIST 1.1
  • Performance Status ≤ 1

Criteria the registry did not label

  • For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BeijingChinaUnknown status
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BeijingChinaUnknown status
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BeijingChinaUnknown status
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BeijingChinaUnknown status
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BeijingChinaUnknown status
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BeijingChinaUnknown status
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ChangchunChinaUnknown status
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ChangchunChinaUnknown status
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ChangshaChinaUnknown status
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ChangshaChinaUnknown status
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ChengduChinaUnknown status
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ChongqingChinaUnknown status
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FuzhouChinaUnknown status
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GuangzhouChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HangzhouChinaUnknown status
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NanjingChinaUnknown status
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ShanghaiChinaUnknown status
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ShanghaiChinaUnknown status
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ShanghaiChinaUnknown status
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ShanghaiChinaUnknown status
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ZhengzhouChinaUnknown status
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Hong KongHong Kong SAR ChinaUnknown status
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ChelyabinskRussiaUnknown status
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MoscowRussiaUnknown status
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MoscowRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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SingaporeSingaporeUnknown status
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SingaporeSingaporeUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.