Clinical trial NCT02813785: A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression, loss of clinical benefit, or unacceptable toxicity.


Eligibility criteria: Inclusion Criteria:

* Histologically documented, locally advanced or metastatic NSCLC
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status
* 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 and/or neoadjuvant regimen or combined modality with curative intent
* Measurable disease per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Adequate hematologic and end organ function
* Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
* Recovery from all acute toxicities from previous therapy

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastases
* Spinal cord compression not definitively treated or not clinically stable
* Leptomeningeal disease
* Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia
* Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
* Pregnant or lactating women
* Significant cardiovascular, pulmonary, or autoimmune disease
* Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization
* Prior treatment with or hypersensitivity to study drug(s) or related compounds
* Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
* Prior allogeneic bone marrow or solid organ transplant
* Known PD-L1-negative expression status
* Positive human immunodeficiency virus (HIV) or active hepatitis B or C
* Receipt of a live attenuated vaccine within 4 weeks prior to randomization
* Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
* Treatment with systemic corticosteroids within 2 weeks prior to randomization

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline until death from any cause (up to approximately 3 years)
Secondary outcomes:
measure: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
timeFrame: Baseline until disease progression or death from any cause (up to approximately 3 years)
measure: Percentage of Participants with Objective Response According to RECIST v1.1
timeFrame: Baseline until disease progression or death from any cause (up to approximately 3 years)
measure: Duration of Objective Response According to RECIST v1.1
timeFrame: From first objective response until disease progression or death from any cause (up to approximately 3 years)
measure: Percentage of Participants with Adverse Events
timeFrame: From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years)
measure: Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
timeFrame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall)
measure: Minimum Observed Serum Concentration (Cmin) of Atezolizumab
timeFrame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall)
measure: Time to Deterioration (TTD) in Lung Cancer Symptoms According to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 C30)
timeFrame: From start of treatment until treatment discontinuation (up to approximately 3 years)
measure: TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13)
timeFrame: From start of treatment until treatment discontinuation (up to approximately 3 years)
measure: Health-Related Quality of Life According to EORTC QLQ-C30 Score
timeFrame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)
measure: Health-Related Quality of Life According to EORTC QLQ-LC13 Score
timeFrame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Chest Hospital; Oncology Department
city: Bengbu
country: China
facility: Affiliated Hospital of Bengbu Medical College
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changzhou
country: China
facility: Changzhou First People's Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Second Affiliated Hospital of Third Military Medical University
city: ChongQing
country: China
facility: Third Affiliated Hospital of Third Military Medical University
city: Guangzhou City
country: China
facility: Sun Yet-sen University Cancer Center
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College Qingdao University
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai chest hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shenyang
country: China
facility: Liaoning cancer Hospital & Institute
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xi'an City
country: China
facility: The First Affiliated Hospital of Xian Jiao Tong University
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail; Oncology
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
city: Sarawak
country: Malaysia
facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
city: Singapore
country: Singapore
facility: National Cancer Centre; Medical Oncology
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital; Medical Oncology
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Chiang Mai
country: Thailand
facility: CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: