NCT01827852

Brief Summary

This prospective observational study will evaluate the efficacy and safety of first-line Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age groups (\<60, 60-69, 70-79, \>80 years) in patients with inoperable advanced, metastatic or recurrent adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months from the start of first-line therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,107

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

July 28, 2017

Status Verified

June 1, 2017

Enrollment Period

4.2 years

First QC Date

April 2, 2013

Last Update Submit

July 25, 2017

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)

    approximately 4.5 years

Secondary Outcomes (5)

  • Overall survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)

    approximately 4.5 years

  • Clinical/demographic patient characteristics at initiation of treatment

    approximately 4.5 years

  • Avastin treatment schedule in routine clinical practice (dosage/duration)

    approximately 4 years

  • Concomitant anti-neoplastic therapy (dosage/duration)

    approximately 4.5 years

  • Safety: Incidence of adverse events in 4 different age groups (<60, 60-69, 70-79, >/=80 years)

    approximately 4.5 years

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with inoperable advanced, metastatic or recurrent predominantly non-squamous adenocarcinoma non-small cell lung cancer

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Histologically confirmed inoperable advanced, metastatic or recurrent pre-dominantly non-squamous adenocarcinoma non-small cell lung cancer

You may not qualify if:

  • Contraindications to Avastin treatment according to the Summary of Product Characteristics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie

Leipzig, 04103, Germany

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 10, 2013

Study Start

March 14, 2013

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

July 28, 2017

Record last verified: 2017-06

Locations

DE(1)