Clinical trial NCT02596958: Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants
Official title: Available - Avastin in Addition to Platinum-based Chemotherapy is Indicated for First-lime Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-small Lung Cancer Other Than Predominantly Squamous Cell Histology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 996
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell and with or without adenocarcinoma histology will be selected.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs
timeFrame: Up to 74 months
Secondary outcomes:
measure: Percentage of Participants Who Withdrew or Modified Treatment
timeFrame: Up to 74 months
measure: Number of Cycles of Systemic Therapy
timeFrame: Up to 74 months
measure: Percentage of Participants With Best Tumor Response Over Time
timeFrame: Up to 74 months
measure: Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades
timeFrame: Up to 74 months
measure: Percentage of Participants With Disease Control
timeFrame: Up to 74 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 74 months
measure: Percentage of Participants Who Died
timeFrame: Up to 74 months
measure: Overall Survival
timeFrame: Up to 74 months
Other outcomes:
Locations:
city: Goslar
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.