Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants

NCT ID: NCT02596958

Last Updated: 2016-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

996 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this non-interventional study is the collection and documentation of data on safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based chemotherapy for first-line treatment in participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology with focus on adenocarcinoma and elderly patients in daily routine.

Detailed Description

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Bevacizumab

Patients will receive six 3-weeks cycle of IV bevacizumab along with platinum-based chemotherapy, followed by maintenance therapy of bevacizumab until progression (approximately 7 months).

Bevacizumab

Intervention Type DRUG

Six 3-weeks cycle of IV bevacizumab will be administered for approximately 7 months.

Interventions

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Bevacizumab

Six 3-weeks cycle of IV bevacizumab will be administered for approximately 7 months.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to (\>=) 18 years
* Histologically confirmed predominantly non-squamous NSCLC that is unresectably advanced, metastatic or recurrent (with or without adenocarcinoma)
* No contraindications to Avastin® according to the current Summary of Product Characteristics (SmPC) for Avastin®
* Therapeutic decision for Avastin® as first line treatment in combination with platinum-based chemotherapy was taken individually and independent of the non-interventional trial.

Exclusion Criteria

N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Goslar, , Germany

Site Status

Countries

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Germany

References

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Zahn MO, Linck D, Losem C, Gessner C, Metze H, Gaillard VE, Tessen HW. AVAiLABLE NIS - AVASTIN(R) in lung cancer treatment in routine oncology practice in Germany. BMC Cancer. 2019 May 10;19(1):433. doi: 10.1186/s12885-019-5618-0.

Reference Type DERIVED
PMID: 31077164 (View on PubMed)

Other Identifiers

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ML21217

Identifier Type: -

Identifier Source: org_study_id

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