Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 1 of 1 for:    NCT 01351415
Previous Study | Return to List | Next Study

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
  Purpose
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.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: Bevacizumab
Drug: Docetaxel
Drug: Erlotinib
Drug: Pemetrexed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Survival (OS) Duration [ Time Frame: Baseline until death (up to approximately 5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 487
Study Start Date: June 2011
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
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).
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351415

  Show 179 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01351415     History of Changes
Other Study ID Numbers: MO22097  2010-022645-14 
Study First Received: May 9, 2011
Last Updated: September 15, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Docetaxel
Erlotinib Hydrochloride
Pemetrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016