Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment atezolizumab (mpdl3280a) [tecentriq], an engineered anti-pdl1 antibody
Phase phase 2
Target PD-1
Sponsor Genentech, Inc.
Start date May 2013
End date January 2015
Trial size 138 participants
Trial identifier NCT01846416, 2013-000177-69, GO28625

Summary

This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.

Eligible participants will be categorized in to three groups as follows:

1. Participants with no prior chemotherapy for advanced disease;

2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);

3. Participants who are 2L+ and previously treated for brain metastases.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Participants with no prior chemotherapy for advanced NSCLC disease will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
atezolizumab (mpdl3280a) [tecentriq], an engineered anti-pdl1 antibody
Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.
(Experimental)
Participants who progress during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
atezolizumab (mpdl3280a) [tecentriq], an engineered anti-pdl1 antibody
Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.
(Experimental)
Participants with previously treated brain metastases and who progress during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
atezolizumab (mpdl3280a) [tecentriq], an engineered anti-pdl1 antibody
Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.

Primary Outcomes

Measure
Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)

Secondary Outcomes

Measure
Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)
time frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Duration of Objective Response According to RECIST v1.1
time frame: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Percentage of Participants With 6-Month Duration of Objective Response
time frame: Month 6
Percentage of Participants With Disease Progression or Death According to RECIST v1.1
time frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Progression-Free Survival (PFS) According to RECIST v1.1
time frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Percentage of Participants With PFS at Month 6 and Month 12 According to RECIST v1.1
time frame: Months 6 and 12
Percentage of Participants With Disease Progression or Death According to Modified RECIST
time frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
PFS According to Modified RECIST
time frame: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Percentage of Participants With PFS at Month 6 and Month 12 According to Modified RECIST
time frame: Months 6 and 12
Percentage of Participants With Death
time frame: Baseline till death or up to 20 months, whichever occurred first
Overall Survival (OS)
time frame: Baseline till death or up to 20 months, whichever occurred first
Maximum Plasma Concentration (Cmax) for Atezolizumab
time frame: Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1
Minimum Plasma Concentration (Cmin) for Atezolizumab
time frame: Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC - PDL1-positive status as determined by an immunohistochemistry assay performed by a central laboratory. A positive result in chemotherapy, chemoradiation of the tumor sample biopsy will satisfy the eligibility criterion - Eastern Cooperative Oncology group Performance Status of 0 or 1 - Life expectancy greater than or equal to 12 weeks - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 - Adequate hematologic and end organ function Exclusion Criteria: - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day 1 - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment - Known central nervous system disease, including treated brain metastases in the following participants: 1. who will not receive prior chemotherapy for advanced disease 2. who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (referred as 2L+ participants) - Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases. - Leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled hypercalcemia

Additional Information

Official title A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Genentech, Inc..