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A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01351415
First received: May 9, 2011
Last updated: September 15, 2016
Last verified: September 2016

May 9, 2011
September 15, 2016
June 2011
June 2016   (final data collection date for primary outcome measure)
Overall Survival (OS) Duration [ Time Frame: Baseline until death (up to approximately 5 years) ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01351415 on ClinicalTrials.gov Archive Site
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Baseline up to PD or death, whichever occurs first (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Objective Response According to RECIST v1.1 [ Time Frame: Baseline up to PD or death, whichever occurs first (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Disease Control According to RECIST v1.1 [ Time Frame: Baseline up to PD or death, whichever occurs first (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Duration of Response (DoR) According to RECIST v1.1 [ Time Frame: Baseline up to PD or death, whichever occurs first (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Percentage of participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 5 years ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) According to RECIST v1.1 [ Time Frame: Baseline up to PD (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Are Alive at Month 6, 12, and 18 [ Time Frame: Month 6, Month 12, Month 18 ] [ Designated as safety issue: No ]
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Disease control rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy
This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Squamous Non-Small Cell Lung Cancer
  • Drug: Bevacizumab
    Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
    Other Name: Avastin
  • Drug: Docetaxel
    Docetaxel 60 or 75 milligram per meter square (mg/m^2) on Day 1 every 21 days.
  • Drug: Erlotinib
    Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
  • Drug: Pemetrexed
    Pemetrexed 500 mg/m^2 IV over 10 minutes on Day 1 every 21 days.
  • Experimental: Bevacizumab + Standard of Care
    Participants will receive bevacizumab on Day 1 of every 21-days cycle along with standard of care (Erlotinib or Docetaxel or Pemetrexed) as second line treatment, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
    Interventions:
    • Drug: Bevacizumab
    • Drug: Docetaxel
    • Drug: Erlotinib
    • Drug: Pemetrexed
  • Active Comparator: Standard of Care
    Participants will receive investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
    Interventions:
    • Drug: Docetaxel
    • Drug: Erlotinib
    • Drug: Pemetrexed

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
487
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed non-squamous NSCLC
  • Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4-6 cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
  • No treatment interruption of Bevacizumab treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
  • Randomization within 4 weeks of progression of disease
  • At least one unidimensionally measurable lesion meeting RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants with adequate hematological, liver, and renal function
  • Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)

Exclusion Criteria:

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local laboratory testing
  • History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of randomization
  • History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding
  • Major cardiac disease
  • Treatment with any other investigational agent within 28 days prior to randomization
  • Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs foreseen
  • Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Belgium,   Brazil,   Denmark,   France,   Germany,   Greece,   Italy,   Japan,   Lebanon,   Mexico,   Netherlands,   Oman,   Slovakia,   Spain,   United Arab Emirates
Jordan,   Qatar
 
NCT01351415
MO22097, 2010-022645-14
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2016

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