Observational Study to Evalute the Efficacy and Safety of Avastin (Bevacizumab) in Addition to Platinum-Based Chemotherapy for First-Line Treatment of Participants With Non-Small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03170284
• Date of registration: 26/05/2017
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: Observational Study to Evalute the Efficacy and Safety of Avastin (Bevacizumab) in Addition to Platinum-Based Chemotherapy for First-Line Treatment of Participants With Non-Small Cell Lung Cancer AVALANCHE
• Scientific title: A Multi-Center Observational Survey of the Efficacy and Safety of Avastin in Addition to Platimun-Based Chemotherapy for First-Line Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology
• Date of first enrolment: June 17, 2008
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03170284
• Study type: Observational
• Phase: N/A

Countries of recruitment

Hungary

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

In accordance with the SPC. Most important criteria:

- Histology or cytology proven inoperable, locally advanced,metastatic or recurrent
(stage IIIB/IV) NSCLC other than predominantly squamous cell histology

- First-line treatment is indicated

- No previous treatment with Bevacizumab

Exclusion Criteria:

In accordance with the SPC. Most important criteria:

- Hypersensitivity to the active ingredient or to any of the excipients

- Hypersensitivity to products derived from Chinese hamster ovary (CHO) cells or to
other recombinant human or humanized antibodies

- Pregnancy

- Bevacizumab is contraindicated in the presence of untreated central nervous system
metastases



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Drug: Bevacizumab

Primary Outcome(s)

Time to Disease Progression [Time Frame: up to 45 months]

Secondary Outcome(s)

Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) [Time Frame: Up to 45 months]

Overall Survival [Time Frame: Up to 45 months]

Best Tumor Response [Time Frame: Up to 45 months]

Secondary ID(s)

ML21783

Source(s) of Monetary Support

Please refer to primary and secondary sponsors