A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy

Carcinoma, Non-Small-Cell Lung Clinical Trial

— IMpower210  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813785
• Other study ID #: YO29232
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2016
• Est. completion date: December 27, 2022

Study information

• Verified date: January 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: December 27, 2022
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
• Docetaxel
Docetaxel will be administered as 75 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Beijing Chest Hospital; Oncology Department	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences.	Beijing
China	Affiliated Hospital of Bengbu Medical College	Bengbu
China	Jilin Cancer Hospital	Changchun
China	the First Hospital of Jilin University	Changchun
China	Changzhou First People's Hospital	Changzhou
China	West China Hospital, Sichuan University	Chengdu
China	Second Affiliated Hospital of Third Military Medical University	Chongqing
China	Third Affiliated Hospital of Third Military Medical University	ChongQing
China	Guangdong General Hospital	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Sun Yet-sen University Cancer Center	Guangzhou City
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou
China	Sir Run Run Shaw Hospital	Hangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	Jiangsu Cancer Hospital	Nanjing City
China	The Affiliated Hospital of Medical College Qingdao University	Qingdao
China	Shanghai chest hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Liaoning cancer Hospital & Institute	Shenyang
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Xian Jiao Tong University	Xi'an City
China	Zhejiang Cancer Hospital	Zhejiang
China	Henan Cancer Hospital	Zhengzhou
Korea, Republic of	Kyungpook National University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Korea University Guro Hospital	Seoul
Malaysia	Hospital Sultan Ismail; Oncology	Johor Bahru
Malaysia	Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi	Kuala Lumpur
Malaysia	Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care	Sarawak
Singapore	National Cancer Centre; Medical Oncology	Singapore
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Thailand	CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

China,  Korea, Republic of,  Malaysia,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		Baseline until death from any cause (up to approximately 3 years)
Secondary	Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1		Baseline until disease progression or death from any cause (up to approximately 3 years)
Secondary	Percentage of Participants with Objective Response According to RECIST v1.1		Baseline until disease progression or death from any cause (up to approximately 3 years)
Secondary	Duration of Objective Response According to RECIST v1.1		From first objective response until disease progression or death from any cause (up to approximately 3 years)
Secondary	Percentage of Participants with Adverse Events		From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years)
Secondary	Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab		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)
Secondary	Minimum Observed Serum Concentration (Cmin) of Atezolizumab		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)
Secondary	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)		From start of treatment until treatment discontinuation (up to approximately 3 years)
Secondary	TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13)		From start of treatment until treatment discontinuation (up to approximately 3 years)
Secondary	Health-Related Quality of Life According to EORTC QLQ-C30 Score		Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)
Secondary	Health-Related Quality of Life According to EORTC QLQ-LC13 Score		Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)