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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01519804
First received: December 19, 2011
Last updated: October 14, 2014
Last verified: October 2014

December 19, 2011
October 14, 2014
April 2012
January 2014   (final data collection date for primary outcome measure)
  • Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01519804 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Overall response rate (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Duration of response (time from first documented objective response to disease progression) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: serum concentration (Cmin/Cmax) [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years ] [ Designated as safety issue: No ]
  • Plasma concentrations of paclitaxel/platinum [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1 and 4 ] [ Designated as safety issue: No ]
  • Serum levels of anti-therapeutic antibodies (MetMAb ATAs) [ Time Frame: Pre-dose Day 1 of Cycles 1, 2 and 4 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Overall response rate (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Duration of response (time from first documented objective response to disease progression) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: serum concetration (Cmin/Cmax) [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years ] [ Designated as safety issue: No ]
  • Plasma concentrations of paclitaxel/platinum [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1 and 4 ] [ Designated as safety issue: No ]
  • Serum levels of anti-therapeutic antibodies (MetMAb ATAs) [ Time Frame: Pre-dose Day 1 of Cycles 1, 2 and 4 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
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)

This multicenter, randomized, double-blind, placebo-controlled study will evalua te the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxe l plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-s mall cell lung cancer (NSCLC). Patients will be randomized to receive either ona rtuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combin ation with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplat in) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 c ycles will continue with either onartuzumab (MetMAb) or placebo as maintenance t herapy until disease progression or unacceptable toxicity occurs.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: Placebo
    Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle
  • Drug: cisplatin/carboplatin
    standard dose iv, Day 1 of each 21-day cycle, 4 cycles
  • Drug: onartuzumab
    15 mg/kg iv, Day 1 of each 21-day cycle
    Other Name: MetMAb
  • Drug: paclitaxel
    200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
  • Experimental: MetMAb+paclitaxel+platinum
    Interventions:
    • Drug: cisplatin/carboplatin
    • Drug: onartuzumab
    • Drug: paclitaxel
  • Active Comparator: Placebo+paclitaxel+platinum
    Interventions:
    • Drug: Placebo
    • Drug: cisplatin/carboplatin
    • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
108
Not Provided
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Argentina,   France,   Germany,   Israel,   Italy,   Latvia,   Spain
 
NCT01519804
GO27820
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP