Observational Study of Afatinib 30 mg Daily

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-25

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 of afatinib at a standard dose of 40 mg daily versus standard of care, 28-53% of patients required a dose reduction due to adverse events (AE) induced by afatinib. The most common AEs are cutaneous and gastrointestinal (diarrhoea, dysphagia, and mucositis). Prevalence of diarrhoea in patients receiving 40 mg of afatinib, in 1st line phase II and III studies is as high as 90.0% (all grades of diarrhoea) and 14.4% (grade 3-4 diarrhoea). Another important gastrointestinal AE is mucositis, which presents in 51.9%-64.4% of patients treated with afatinib, with only 4.4%-8.3% of the cases being grade 3-4. Dose reduction tended to occur in patients who had higher initial afatinib plasma concentrations and led to decreases in the incidence and severity of afatinib-related AEs without affecting therapeutic efficacy. The incidence of gastrointestinal AEs could be decreased \>50% with proper afatinib dose reduction.

The effect of 1st line afatinib 30 mg daily in patients with EGFR mutation-positive NSCLC is unknown. We hypothesize that, in patients with EGFR mutation-positive NSCLC, 1st line afatinib treatment at 30 mg daily is tolerable with less gastrointestinal AEs and with a similar efficacy to standard dose afatinib.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

NCT01953913

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE3

Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations

NCT06062823

NSCLC

RECRUITING PHASE2

Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

NCT02514174

Carcinoma, Non-Small-Cell Lung ErbB Receptors

COMPLETED PHASE4

Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations

NCT02044380

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE3

The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer

NCT04206787

Non-squamous, Non-Small Cell Lung Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 entered patients (i.e., patients that have been treated with the defined medication) will receive continuous treatment of afatinib in the absence of disease progression or meeting any other withdrawal criteria. All patients will visit Investigator at regular intervals for assessment of efficacy and safety as outlined in the Flow Chart for the first 7 cycles treatment. The Investigator will assess the patient at each visit. Tumour response and progression will be assessed using RECIST 1.1 at the Investigator site.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer Epidermal Growth Factor Receptor Mutation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Afatinib 30 mg daily

Oral afatinib 30 mg tablet once daily, continuously

Afatinib

Intervention Type DRUG

Continuous treatment of afatinib 30mg tablet once daily in the absence of disease progression or unacceptable treatment-related toxicity, Investigator decision or patient decision to discontinue study treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Afatinib

Continuous treatment of afatinib 30mg tablet once daily in the absence of disease progression or unacceptable treatment-related toxicity, Investigator decision or patient decision to discontinue study treatment.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Giotrif

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥18 years.
2. ECOG performance status 0-1.
3. Pathologically confirmed diagnosis of Stage IIIB/IV adenocarcinoma of the lung.
4. Have been commenced on first line afatinib 30 mg within 4 weeks of study enrolment.
5. 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.
6. 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.
7. No brain metastases (confirmed by a CT or MRI brain performed within 4 weeks of study enrolment)
8. 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).
9. Archived tissue sample is available.
10. Written informed consent per regulations.

Exclusion Criteria

1. 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.
2. Prior treatment with EGFR targeting small molecules or antibodies.
3. Major surgery within 4 weeks of study treatment.
4. Brain metastases.
5. Meningeal carcinomatosis.
6. Known pre-existing interstitial lung disease (ILD).
7. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No