A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2013-001142-34-HU
• Date of registration: 08/08/2013
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche. Ltd.
• Public title: A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE
• Scientific title: A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE
• Date of first enrolment: 15/10/2013
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001142-34
• 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: 2
• 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, Canada, France, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TSIL
• Affiliation: F. Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line-TSIL
• Affiliation: F. Hoffmann-La Roche Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
•patients must have failed a prior platinum-containing regimen.
•Histologically or cytologically documented locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009); pathological characterization must be sufficient to define patients as having either squamous or non-squamous histology.
•Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Medical Monitor.
• Measurable disease, as defined by RECIST v1.1
• ECOG performance status of 0 or 1
• Life expectancy > 12 weeks

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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion criteria:
• Known active or untreated central nervous system (CNS) metastases.
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomization
• Leptomeningeal disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Uncontrolled tumor-related pain



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

Health Condition(s) or Problem(s) studied

NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE
MedDRA version: 16.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864

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

Intervention(s)

Product Name: Not Applicable
Product Code: MPDL3280A-RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not Applicable
Current Sponsor code: MPDL3280A
Other descriptive name: RO5541267
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 125-

Trade Name: Docetaxel
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
Other descriptive name: DOCETAXEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: See E.5.1

Main Objective: • To estimate the efficacy of MPDL3280A compared with docetaxel as measured by OS
•To evaluate the safety and tolerability of MPDL3280A compared with docetaxel

Primary end point(s): • OS, defined as the time from randomization to death from any cause

Secondary Objective: •To evaluate the efficacy of MPDL3280A compared with docetaxel with respect to anti-tumor effects measured by overall response, DOR, and PFS per RECIST v1.1
•To evaluate the efficacy of MPDL3280A with respect to anti-tumor effects measured by overall response, DOR, and PFS per modified RECIST

Secondary Outcome(s)

Secondary end point(s): • Overall response (partial response plus complete response), as determined by investigator using RECIST v1.1 criteria
• PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause

Timepoint(s) of evaluation of this end point: See E.5.2

Secondary ID(s)

GO28753

2013-001142-34-BE

Source(s) of Monetary Support

F. Hoffman-La Roche Ltd.

Ethics review

Status: Approved
Approval date: 30/09/2013
Contact:

Results

• Results available: Yes
• Date Posted: 22/05/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001142-34/results