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Completed

NCT Number: NCT01519804

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

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.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle

cisplatin/carboplatin

Drug

standard dose iv, Day 1 of each 21-day cycle, 4 cycles

Onartuzumab

Drug

15 mg/kg iv, Day 1 of each 21-day cycle

Other names: MetMAb

paclitaxel

Drug

200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles

Primary outcomes

  1. Progression-free survival (tumor assessments according to RECIST criteria)

    Time frame: up to approximately 32 months

  2. Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC

    Time frame: up to approximately 32 months

Secondary outcomes

  1. Overall survival

    Time frame: up to approximately 32 months

  2. Overall response rate (tumor assessments according to RECIST criteria)

    Time frame: up to approximately 32 months

  3. Duration of response (time from first documented objective response to disease progression)

    Time frame: up to approximately 32 months

  4. 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

  5. Safety: Incidence of adverse events

    Time frame: up to approximately 32 months

  6. 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

  7. Plasma concentrations of paclitaxel/platinum

    Time frame: Pre- and post-dose on Day 1 of Cycles 1 and 4

  8. Serum levels of anti-therapeutic antibodies (MetMAb ATAs)

    Time frame: Pre-dose Day 1 of Cycles 1, 2 and 4

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 27, 2012
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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