A Study of Avastin (Bevacizumab) Versus Placebo in Combination With Carboplatin/Paclitaxel) in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01364012
First received: May 27, 2011
Last updated: September 22, 2014
Last verified: September 2014

May 27, 2011
September 22, 2014
May 2011
March 2016   (final data collection date for primary outcome measure)
Progression-free survival (PFS), tumour assessments according to RECIST criteria [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01364012 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]
  • 1-year survival rate [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Overall response rate (ORR): complete response + partial response [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]
  • Correlation of baseline vascular endothelial growth factor (VEGF) plasma levels with clinical outcome (PFS/OS/ORR) [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) Versus Placebo in Combination With Carboplatin/Paclitaxel) in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy
A Randomized, Double-blinded, Placebo-controlled, Multicenter Phase III Study Comparing Bevacizumab Plus Carboplatin/Paclitaxel Versus Placebo Plus Carboplatin / Paclitaxel in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy.

This randomized, double-blind, placebo-controlled study will evaluate the effica cy and safety of Avastin (bevacizumab) versus placebo in combination with carbop latin/paclitaxel in patients with advanced or recurrent non-squamous non-small c ell lung cancer who have not received prior chemotherapy for advanced disease. P atients will be randomized to receive either Avastin 15 mg/kg intravenously or p lacebo on Day 1 of each 3-week cycle, plus up to 6 cycles of carboplatin/paclita xel. Anticipated time on study treatment is until disease progression or unaccep table toxicity occurs. After progression, patients in the Avastin-arm may contin ue to receive Avastin in combination with approved second- and third-line treatm ent at the discretion of the investigator, up to the third progression.

Not Provided
Interventional
Phase 3
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: bevacizumab [Avastin]
    15 mg/kg intravenously (iv) on Day 1 of each 3-week cycle
  • Drug: carboplatin
    AUC 6.0 iv on Day 1 of each 3-week cycle, up to 6 cycles
  • Drug: paclitaxel
    175 mg/m2 iv on Day 1 of each 3-week cycle, up to 6 cycles
  • Drug: placebo
    15 mg iv on Day 1 of each 3-week cycle
  • Experimental: A
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: carboplatin
    • Drug: paclitaxel
  • Active Comparator: B
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: placebo
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
276
March 2016
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Locally advanced (Stage IIIb not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate haematological, renal and liver function

Exclusion Criteria:

  • Prior chemotherapy or treatment with another systemic anti-cancer agent for the current stage of the disease (IIIb, IV or recurrent)
  • Mixed non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
  • Evidence of tumour invading major blood vessels on imaging
  • CNS metastases, even if previously treated
  • History of haemoptysis in the 3 months prior to enrollment
  • History or evidence of inherited bleeding diathesis or coagulopathy
  • Uncontrolled hypertension and/or history of hypertensive crisis or hypertensive encephalopathy
  • Clinically significant cardiovascular or vascular disease
  • Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or localized prostate cancer or ductal carcinoma in situ treated surgically with curative intent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01364012
YO25404
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

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