Clinical study to evaluate atezolizumab (MPDL3280A) in patients with PD-L1- positive locally or metastatic non-small cell lung cancer

• Register: EUCTR
• Last refreshed on: 30 April 2018
• Main ID: EUCTR2013-000177-69-BE
• Date of registration: 29/08/2013
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: Clinical study to evaluate atezolizumab (MPDL3280A) in patients with PD-L1- positive locally or metastatic non-small cell lung cancer
• Scientific title: A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB (MPDL3280A) IN PATIENTS WITH PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
• Date of first enrolment: 02/09/2013
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000177-69
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, France, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann La Roche Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
- Histologically or cytologically documented Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC
- PD-L1-positive status as determined by an IHC assay performed by a central laboratory
- ECOG performance status of 0 or 1
- Measurable disease, as defined by RECIST v1.1
- For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) during the treatment period and to continue its use for 5 months after the last dose of atezolizumab

Inclusion Criteria Unique to Cohort 1:
- No prior chemotherapy for locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
Inclusion Criteria Unique to Cohorts 2 and 3
- Disease progression during or following prior platinum-based chemotherapy for locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
Inclusion Criteria Unique to Cohort 3
- Diagnosis of brain metastases by brain MRI or contrast-enhanced CT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- 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
- Leptomeningeal disease


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: Atezolizumab
Product Code: MPDL3280A-RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Atezolizumab
Current Sponsor code: MPDL3280A
Other descriptive name: RO5541267
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Main Objective: The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab in patients with PD-L1-positive locally advanced or metastatic NSCLC, as measured by investigator-assessed ORR according to modified RECIST

Timepoint(s) of evaluation of this end point: timepoint for evaluation will be 6 months after approximately 130 patients have been enrolled;

Primary end point(s): investigator overall response rate (ORR) per modified RECIST

Secondary Objective: - To evaluate PFS and DOR according to modified RECIST
- To evaluate the efficacy of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic NSCLC, as measured by investigator-assessed ORR, DOR, PFS, where all response endpoints are determined according to RECIST 1.1
- To evaluate OS
- To evaluate PFS in patients who experience a confirmed partial response (PR) or confirmed response CR per modified RECIST at any time on study treatment
- To evaluate the safety and tolerability of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic NSCLC
- To characterize the pharmacokinetics of Atezolizumab
- To evaluate the incidence and titers of ATAs against Atezolizumab and to explore the potential relationship of the immunogenicity response with pharmacokinetics, safety, and efficacy

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: timepoint for evaluation is same as for primary endpoint, with updated analysis approximately 12 months after the last patient is enrolled in the study

Secondary end point(s): ORR, duration of response (DOR), progression-free survival (PFS), and overall survival (OS) per RECIST v1.1,

Secondary ID(s)

GO28625

Source(s) of Monetary Support

Genentech Inc. c/o F. Hoffmann La Roche Ltd.