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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02008227
• Date of registration: 06/12/2013
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: 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 OAK
• Scientific title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
• Date of first enrolment: March 11, 2014
• Target sample size: 1225
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02008227
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Serbia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC

- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens

- Disease progression during or following treatment with a prior platinum-containing
regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease
recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant
regimen or combined modality (e.g., chemoradiation) regimen with curative intent

- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

- Known active or untreated central nervous system (CNS) metastases

- Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with a negligible risk of metastasis or death and treated with
expected curative outcome

- History of autoimmune disease

- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation
field (fibrosis) is permitted

- Active hepatitis B or hepatitis C

- Prior treatment with docetaxel

- Prior treatment with cluster of differentiation 137 (CD137) agonists,
anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1
(anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Squamous Non-Small Cell Lung Cancer

Intervention(s)

Drug: Docetaxel

Drug: Atezolizumab

Primary Outcome(s)

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

Overall Survival (OS): PP-ITT [Time Frame: Baseline until death due to any cause (up to approximately 2.25 years)]

OS: TC1/2/3 or IC1/2/3 Subgroup of PP [Time Frame: Baseline until death due to any cause (up to approximately 2.25 years)]

OS: TC2/3 or IC2/3 Subgroup of SP [Time Frame: Baseline until death due to any cause (up to approximately 2.87 years)]

OS: SP-ITT [Time Frame: Baseline until death due to any cause (up to approximately 2.87 years)]

OS: TC3 or IC3 Subgroup of SP [Time Frame: Baseline until death due to any cause (up to approximately 2.87 years)]

OS: TC1/2/3 Or IC1/2/3 Subgroup of SP [Time Frame: Baseline until death from any cause (approximately 2.87 years)]

Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP [Time Frame: Baseline until death due to any cause (up to approximately 2.25 years)]

Secondary Outcome(s)

EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

EORTC QLQ-LC13 Questionnaire Score: Sore Mouth [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT [Time Frame: Baseline up to PD or Death (up to approximately 2.25 years)]

PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

EORTC QLQ-LC13 Questionnaire Score: Alopecia [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT [Time Frame: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

EORTC QLQ-LC13 Questionnaire Score: Hemoptysis [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT [Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)]

EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

DOR as Determined by Investigator Using RECIST v1.1: SP ITT [Time Frame: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)]

EORTC QLQ-LC13 Questionnaire Score: Coughing [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [Time Frame: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

EORTC QLQ-C30 Questionnaire Score: GHS Scale [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

EORTC QLQ-LC13 Questionnaire Score: Dysphagia [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

EORTC QLQ-LC13 Questionnaire Score: Dyspnea [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

EORTC QLQ-LC13 Questionnaire Score: Pain in Chest [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

Minimum Observed Serum Atezolizumab Concentration (Cmin) [Time Frame: Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)]

EORTC QLQ-C30 Questionnaire Score: Functional Subscales [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

Maximum Observed Serum Atezolizumab Concentration (Cmax) [Time Frame: Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)]

EORTC QLQ-C30 Questionnaire Score: Symptom Subscale [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13) [Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)]

Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT [Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP [Time Frame: Baseline up to PD or Death (up to approximately 2.25 years)]

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab [Time Frame: Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])]

PFS as Determined by Investigator Using RECIST v1.1: SP-ITT [Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)]

Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT [Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

Secondary ID(s)

2013-003331-30

GO28915

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02008227