Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

Conditions

• Squamous Cell Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
• Docetaxel — DRUG

Study Details

The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

Key Dates

Start date

Oct 16, 2012

Status verified

Nov 2022

Primary completion

Nov 17, 2014

Completion

Aug 16, 2021

Study Design

Enrollment

272 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Nivolumab
  Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
• Experimental: Arm B: Docetaxel
  Docetaxel 75 mg/m\^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

Primary Outcome Measure

Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint [ Time Frame: Randomization until 199 deaths, up to November 2014, approximately 25 months ]

Locations (39)

Find similar trials in Scottsdale, AZ

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