Status:
RECRUITING
Observational Study of Afatinib 30 mg Daily
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Non-Small Cell Lung Cancer
Epidermal Growth Factor Receptor Mutation
Eligibility:
All Genders
18-99 years
Brief Summary
Afatinib, a first-in-class irreversible ErbB family blocker, is a 1st line treatment option for patients with advanced stage NSCLC harbouring sensitizing EGFR mutations. In randomized 1st line studies...
Detailed Description
This is a multi-country, multi-centre, study designed to collect clinical data and to evaluate efficacy and safety of patients treated with afatinib 30 mg at the Investigator's discretion. All entere...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- ECOG performance status 0-1.
- Pathologically confirmed diagnosis of Stage IIIB/IV adenocarcinoma of the lung.
- Have been commenced on first line afatinib 30 mg within 4 weeks of study enrolment.
- Documented EGFR mutation(s)-positive NSCLC (common mutations: Del19 and L858R) from tumour biopsy material. Results of EGFR mutation test must be available before taking Afatinib.
- A CT thorax/ abdomen within 4 weeks of study enrolment with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- No brain metastases (confirmed by a CT or MRI brain performed within 4 weeks of study enrolment)
- Documented adequate organ function before taking Afatinib:
- Absolute neutrophil count (ANC) ≥1500/mm3. (ANC \>1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the Investigator and in discussion with the sponsor-Investigator).
- Platelet count ≥75,000/mm3.
- Estimated creatinine clearance using Cockcroft Gault calculation of at least 45 ml/min.
- Total Bilirubin ≤1.5 times upper limit of (institutional/central) normal (Patients with Gilbert's syndrome total bilirubin must be ≤4 times institutional upper limit of normal).
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≤3 times the upper limit of (institutional/central) normal (ULN) (if related to liver metastases ≤5 times ULN).
- Archived tissue sample is available.
- Written informed consent per regulations.
Exclusion
- Prior chemotherapy for Stage IIIB/IV adenocarcinoma of the lung. Neo-/adjuvant chemotherapy, CT-RT or RT is permitted if it has been elapsed for =12 months prior to disease progression.
- Prior treatment with EGFR targeting small molecules or antibodies.
- Major surgery within 4 weeks of study treatment.
- Brain metastases.
- Meningeal carcinomatosis.
- Known pre-existing interstitial lung disease (ILD).
- Patients with a significant disease other than lung cancer; a significant disease is defined as a disease which, in the opinion of the investigator, may:
- put the patient at risk because of participation in the study
- influence the results of the study
- cause concern regarding the patient's ability to participate in the study.
Key Trial Info
Start Date :
October 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04909073
Start Date
October 25 2022
End Date
December 1 2025
Last Update
May 17 2024
Active Locations (1)
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1
Nationa University Hospital
Singapore, Singapore