A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  1200 mg IV infusion on Day 1 of each 21-day cycle
• Docetaxel — DRUG
  75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle

Study Details

This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Key Dates

Start date

Mar 11, 2014

Status verified

Dec 2019

Primary completion

Jul 7, 2016

Completion

Jan 9, 2019

Study Design

Enrollment

1,225 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
  Atezolizumab 1200 milligrams (mg) was administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
• Active Comparator: Docetaxel
  Docetaxel 75 milligrams per meter square (mg/m\^2) was administered via IV infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.

Primary Outcome Measure

Percentage of Participants Who Died: PP-ITT [ Time Frame: Baseline until death due to any cause (up to approximately 2.25 years) ]

Locations (59)

Find similar trials in Bakersfield, CA

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