Observational study of afatinib for lung cancer treatment

An Observational Study of Afatinib 30 mg Daily in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harbouring Common EGFR Mutations Treated With Afatinib

This study is testing if a lower dose of afatinib can safely help people with advanced lung cancer that has specific genetic changes.

Quick facts

• Study type: Observational
• Enrollment: 69 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: National University Hospital, Singapore (Academic / other)
• Drugs / interventions: afatinib, chemotherapy
• Locations: 1 site (Singapore)
• Trial ID: NCT04909073 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the efficacy and safety of afatinib at a reduced dose of 30 mg daily for patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR mutations. Participants will receive continuous treatment unless disease progression occurs or other withdrawal criteria are met. Regular assessments will be conducted to monitor tumor response and adverse events, with efficacy evaluated using RECIST 1.1 criteria. The study aims to gather clinical data to better understand the impact of a lower dose on treatment outcomes and side effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stage IIIB/IV adenocarcinoma of the lung and documented EGFR mutations who have recently started afatinib treatment.

Not a fit: Patients with brain metastases or those who have not been diagnosed with EGFR mutation-positive NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective dosing strategy for patients with EGFR mutation-positive NSCLC.

How similar studies have performed: Previous studies have shown that dose reductions in afatinib can lead to decreased adverse events, suggesting that this approach may be beneficial.

Eligibility criteria

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.

Where this trial is running

Singapore

• Nationa University Hospital — Singapore, Singapore (Recruiting)

Conditions Non-Small Cell Lung Cancer; Epidermal Growth Factor Receptor Mutation; afatinib; EGFR mutation-positive NSCLC