A phase III clinical study to evaluate the efficacy and safety of MPDL3280A in combination with carboplatin + nab-paclitaxel and MPDL328-A in combination with carboplatin + paclitaxel in stage IV squamous non-small cell lung cancer patients.

• Register: EUCTR
• Last refreshed on: 17 August 2021
• Main ID: EUCTR2014-003208-59-IT
• Date of registration: 16/04/2015
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A phase III clinical study to evaluate the efficacy and safety of MPDL3280A in combination with carboplatin + nab-paclitaxel and MPDL328-A in combination with carboplatin + paclitaxel in stage IV squamous non-small cell lung cancer patients.
• Scientific title: A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN - PACLITAXEL OR MPDL3280A IN COMBINATION WITH CARBOPLATIN- NAB PACLITAXEL VERSUS CARBOPLATIN - NAB-PACLITAXEL IN CHEMOTHERAPY NAÏVE PATIENTS WITH STAGE IV SQUAMOUS NON-SMALL CELL LUNG CANCER
• Date of first enrolment: 08/06/2015
• Target sample size: 1200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003208-59
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; 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: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Peru, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Ukraine, 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:
• ECOG performance status of 0 or 1
• Histologically or cytologically confirmed, Stage IV squamous NSCLC
• No prior treatment for Stage IV squamous NSCLC
Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with erlotinib, gefitinib, or another EGFR tyrosine kinase inhibitor (TKI) appropriate for the treatment of EGFR-mutant NSCLC.
Patients with an ALK fusion oncogene must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ALK inhibitors (i.e. crizotinib) appropriate for the treatment of NSCLC in patients having an ALK fusion oncogene.
• Patients who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy or completion of chemoradiotherapy.
• Measurable disease, as defined by RECIST v1.1
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 720
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480

Exclusion criteria:
• Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
• 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 (once monthly or more frequently)
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Positive test for HIV


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

Health Condition(s) or Problem(s) studied

SQUAMOUS NON-SMALL CELL LUNG CANCER

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

Intervention(s)

Product Name: MPDL3280A-RO5541267-F-03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not Yet defined
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Trade Name: Abraxane
Product Name: nab-paclitaxel
Product Code: RO024-7506
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): • PFS, defined as the time from randomization to the first occurrence of the disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first

Secondary Objective: • To evaluate the efficacy of MPDL3280A as measured by investigator-assessed ORR according to RECIST v1.1 in each of the two treatment comparisons
• To evaluate the efficacy of MPDL3280A as measured by OS in each of the two treatment comparisons
• To evaluate the efficacy of MPDL3280A as measured by investigator-assessed duration of response (DOR) according to RECIST v1.1 in each of the two treatment comparisons

Main Objective: • To evaluate the efficacy of MPDL3280A in the ITT population as measured by investigator-assessed PFS according to RECIST v1.1 in each of the following two treatment comparisons:
MPDL3280A + carboplatin + paclitaxel versus carboplatin + nab-paclitaxel
MPDL3280A + carboplatin + nab-paclitaxel versus carboplatin + nab-paclitaxel
• To evaluate the efficacy of MPDL3280A in the PD-L1-selected population as measured by investigator-assessed PFS according to RECIST v1.1 in each of the two treatment comparisons

Timepoint(s) of evaluation of this end point: Please refer to E.5.1

Secondary Outcome(s)

Secondary end point(s): • Objective response, defined as partial response (PR) or complete response (CR) as determined by the investigator according to RECIST v1.1
• OS, defined as the time from randomization to death from any cause
• DOR, defined as the time from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first

Timepoint(s) of evaluation of this end point: Please refer to E.5.2

Secondary ID(s)

GO29437

Source(s) of Monetary Support

F. Hoffmann - La Roche Ltd

Ethics review

Status: Approved
Approval date: 11/05/2015
Contact:

Results

• Results available: Yes
• Date Posted: 13/10/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-003208-59/results