Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment atezolizumab
Phase phase 2
Target PD-1
Sponsor Genentech, Inc.
Start date May 2013
End date January 2015
Trial size 128 participants
Trial identifier NCT01846416, 2013-000177-69, GO28625

Summary

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients will receive an intravenous dose of 1200 mg Atezolizumab on Day 1 of 21-day cycles until disease progression.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
atezolizumab
1200 mg intravenously on Day 1 of 21-day cycles until disease progression

Primary Outcomes

Measure
Objective response as assessed by the investigator according to modified Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Approximately 5 years

Secondary Outcomes

Measure
Objective response according to standard RECIST v1.1
time frame: Approximately 5 years
Duration of response according to standard RECIST v1.1
time frame: Approximately 5 years
Progression-free survival according to standard RECIST v1.1
time frame: Approximately 5 years
Progression-free survival according to modified RECIST
time frame: Approximately 5 years
Duration of response according to modified RECIST
time frame: Approximately 5 years
Safety: Incidence of adverse events
time frame: Approximately 5 years
Safety: Incidence of anti-therapeutic antibodies against atezolizumab
time frame: Approximately 5 years
Pharmacokinetics: Serum atezolizumab maximum serum concentration
time frame: Day 1 of Cycle 1
Pharmacokinetics: Serum atezolizumab minimum serum concentration
time frame: Day 1 of Cycles 2, 4, and 8 and at study termination

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria

  • Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent non-small cell lung cancer (NSCLC)
  • PDL1-positive status as determined by an IHC assay performed by a central laboratory
  • ECOG Performance Status of 0 or 1
  • Life expectancy >= 12 weeks
  • Measurable disease, as defined by RECIST v1.1
  • 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 Tyrosine kinase inhibitors approved for treatment of NSCLC discontinued > 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 CNS disease, including treated brain metastases: Cohorts 1 and 2
  • Patients with a history of treated asymptomatic brain metastases are allowed in Cohort 3
  • 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 July 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..