GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

NCT02047903 | Completed Results

• 1 other identifier: 1200.205
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Rate After 12 Months

  The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.

  After 12 months

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  From the initial dose of study drug until end of the treatment period, up to 48 months.

• Disease Control Rate (DCR)

  From the initial dose of study drug until end of the treatment period, up to 48 months.

• Progression Free Survival (PFS)

  From first administration of the trial drug until objective tumour progression or death, up to 48 months.

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.

• Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia

  From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.

Study Arms (1)

Afatinib

Drug: Afatinib

Interventions

Afatinib DRUG

50, 40, 30 or 20 mg

Afatinib

Eligibility Criteria

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

Study Population

NSCLC-EGFR mutation positive

You may qualify if:

• EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations
• Age \>= 18 years
• No diagnostic or therapeutic measures beyond routine clinical practice are required
• Patients for whom the treating physician has decided to initiate treatment with GIOTRIF

You may not qualify if:

• Contraindication for Afatinib according to the Summary of Product characteristics
• Participation in another clinical study until 30 days after end of treatment
• Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted)
• Previous treatment with an EGFR-tyrosine kinase inhibitor
• Patients not willing or not able to fill in quality of life questionnaires
• Patients with missing or impaired legal capacity
• Pregnancy

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

Related Publications (1)

• Brueckl WM, Reck M, Schafer H, Neben K, Griesinger F, Rawluk J, Kruger S, Kokowski K, Ficker JH, Moller M, Schueler A, Laack E. Older patients with EGFR mutation-positive non-small cell lung cancer treated with afatinib in clinical practice: A subset analysis of the non-interventional GIDEON study. J Geriatr Oncol. 2023 Jan;14(1):101394. doi: 10.1016/j.jgo.2022.10.009. Epub 2022 Oct 30.

  PMID: 36323612 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 28, 2014
• Study Start: March 5, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2019-12

Locations

DE (1)