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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596958
• Other study ID #: ML21217
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: February 5, 2016
• Start date: September 2007
• Est. completion date: October 2013

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial 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 unresactable 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 996
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to (>=) 18 years

• Histologically confirmed predominantly non-squamous NSCLC that is unresactably 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:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs	ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite. Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin. ADRs includes serious as well as non-serious ADRs.	Up to 74 months	No
Secondary	Percentage of Participants Who Withdrew or Modified Treatment	Percentage of participants who withdrew treatment or experienced at least 1 dose deviation in relation to the planned Avastin therapy were reported.	Up to 74 months	No
Secondary	Number of Cycles of Systemic Therapy	Number of cycles of systemic therapy was the mean number of cycles received by participants in combination therapy with Avastin and chemotherapy and with Avastin monotherapy (maintenance).	Up to 74 months	No
Secondary	Percentage of Participants With Best Tumor Response Over Time	Best tumor response (assessed as per clinical routine of the individual center) was categorized according to the following criteria at the investigator discretion: complete response (CR: commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), partial response (PR: commonly defined as at least a 30 percent [%] decrease in the sum of the longest diameter [LD] of target lesions, no progression in non-target lesion, and no new lesion), stable disease (SD: commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD], in addition to no new target lesions). PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and not evaluable (NE).	Up to 74 months	No
Secondary	Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades	ECOG Performance Status measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.	Up to 74 months	No
Secondary	Percentage of Participants With Disease Control	Disease control was defined as having achieved CR (commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), PR (commonly defined as at least a 30% decrease in the sum of the LD of target lesions, no progression in non-target lesion, and no new lesion), or SD (commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, in addition to no new target lesions) during the course of observation which were assessed as per investigator discretion. PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and NE.	Up to 74 months	No
Secondary	Progression Free Survival (PFS)	PFS was defined as the time (months) between the start of therapy and progression (unequivocal progression of existing non-target lesions) or death. Progression: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. PFS was estimated using Kaplan-Meier method.	Up to 74 months	No
Secondary	Percentage of Participants Who Died		Up to 74 months	No
Secondary	Overall Survival	Overall survival was defined as the time (months) between the start of therapy and the date of death.	Up to 74 months	No