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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519804
• Other study ID #: GO27820
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2011
• Last updated: September 1, 2016
• Start date: April 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Placebo
Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle
• cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
• onartuzumab
15 mg/kg iv, Day 1 of each 21-day cycle
• paclitaxel
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  France,  Germany,  Israel,  Italy,  Latvia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (tumor assessments according to RECIST criteria)		up to approximately 32 months	No
Primary	Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC		up to approximately 32 months	No
Secondary	Overall survival		up to approximately 32 months	No
Secondary	Overall response rate (tumor assessments according to RECIST criteria)		up to approximately 32 months	No
Secondary	Duration of response (time from first documented objective response to disease progression)		up to approximately 32 months	No
Secondary	Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)		up to approximately 32 months	No
Secondary	Safety: Incidence of adverse events		up to approximately 32 months	No
Secondary	Pharmacokinetics: serum concentration (Cmin/Cmax)		Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years	No
Secondary	Plasma concentrations of paclitaxel/platinum		Pre- and post-dose on Day 1 of Cycles 1 and 4	No
Secondary	Serum levels of anti-therapeutic antibodies (MetMAb ATAs)		Pre-dose Day 1 of Cycles 1, 2 and 4	No