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

NCT02596958 | Completed Results

• 1 other identifier: ML21217
• Study Type: observational
• Target: 996
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Percentage of Participants Who Withdrew or Modified Treatment

  Up to 74 months

• Number of Cycles of Systemic Therapy

  Up to 74 months

• Percentage of Participants With Best Tumor Response Over Time

  Up to 74 months

• Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades

  Up to 74 months

• Percentage of Participants With Disease Control

  Up to 74 months

Study Arms (1)

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).

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

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

Also known as: Avastin

Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Goslar, 38642, Germany

Location

Related Publications (1)

• 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.

  PMID: 31077164 DERIVED

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 4, 2015
• Study Start: September 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 4, 2016
• Results First Posted: March 4, 2016

Record last verified: 2016-03

Locations

DE (1)