Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect

Plain-language summary

This study compares a traditional Chinese medicine formula with placebo to prevent the skin side effects caused by EGFR-TKI therapy (afatinib) in patients with EGFR-mutated lung adenocarcinoma. It enrolled patients with locally advanced or metastatic disease who were receiving afatinib as first-line treatment. The study was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

China Medical University Hospital

Intervention

TCM Formula, Placebo

Start date

5/12/2016

Estimated completion

2/28/2021

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Patients with histologically confirmed diagnosis of locally advanced or metastatic lung adenocarcinoma with EGFR mutations,
2. Patients with an Eastern Cooperative Oncology Group performance status score of 0-2,
3. Patients receiving afatinib as first-line treatment to ensure a shorter time to observe skin adverse effects of any grade,
4. Patients with measurable disease evaluated by the Response Evaluation Criteria in Solid Tumors (version 1.1),
5. Patients with brain metastases were included after adequate treatment.

Exclusion Criteria: -