A Study of Onartuzumab (MetMAb) Versus Placebo in Combina... | NCT01519804

Studies
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

NCT01519804

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

Sep 2, 2016Estimated

Enrollment

108Actual

Phase

Phase 2

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

Placebo
cisplatin/carboplatin
onartuzumab
paclitaxel

Countries

United States
Argentina
France
Germany
Israel
Italy
Latvia
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Sep 2015Actual

First Submitted Date

Dec 19, 2011

First Submission Date that Met QC Criteria

Jan 24, 2012

First Posted Date

Jan 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 29, 2016

Certification/Extension First Submitted that Passed QC Review

Jun 29, 2016

Certification/Extension First Posted Date

Jul 1, 2016Estimated

Last Update Submitted Date

Sep 1, 2016

Last Update Posted Date

Sep 2, 2016Estimated

Description Module

Brief Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MetMAb+paclitaxel+platinum	Experimental		Drug: cisplatin/carboplatin Drug: onartuzumab Drug: paclitaxel
Placebo+paclitaxel+platinum	Active Comparator		Drug: Placebo Drug: cisplatin/carboplatin Drug: paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle	Placebo+paclitaxel+platinum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (tumor assessments according to RECIST criteria)		up to approximately 32 months
Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC		up to approximately 32 months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		up to approximately 32 months
Overall response rate (tumor assessments according to RECIST criteria)		up to approximately 32 months
Duration of response (time from first documented objective response to disease progression)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, >/= 18 years of age
Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
No prior chemotherapy for squamous NSCLC
Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
Radiographic evidence of disease

Exclusion Criteria:

Prior systemic treatment for Stage IIIB or IV squamous NSCLC
NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
Prior exposure to experimental treatment targeting either the HGF or Met pathway
Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
Pregnant or lactating women
Uncontrolled diabetes
Impaired bone marrow, liver or renal function as defined by protocol
Significant history of cardiovascular disease
Positive for HIV infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama	35805	United States

ID	Term
D002945	Cisplatin
D016190	Carboplatin
C584058	onartuzumab
D017239	Paclitaxel

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes