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Substance / Medication

Afatinib

SNOMED 703579002UMLS C2987648

Overview

Active Ingredient
afatinib
RxNorm CUI
1430438
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.Updated: 2025-11-13T00:00:00.000ZFull label on DailyMed

Contraindications

When this intervention should not be used

None.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Non-small cell lung cancer
Squamous cell carcinoma

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

4 trials linked to this intervention

4
Total Trials
2
Recruiting
2
With Results

Recent Trials

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

NCT02465060Phase 2Active Not Recruiting6452 enrolled

AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients with EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC

NCT04413201Phase 4Active Not Recruiting34 enrolled

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

NCT02514174Phase 4Completed25 enrolled

Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

NCT02208843Phase 4Completed60 enrolled
View all 4 trials on ClinicalTrials.gov

Research Evidence

Published studies and systematic reviews

Sort:
Molecular profiling of afatinib-resistant non-small cell lung cancer cells in vivo derived from mice.
Chung Cheng-Ta, Yeh Kai-Chia, Lee Chia-Huei et al. · Pharmacol Res · 2020
PMID: 32896579Meta-Analysis
Risk of Treatment-Related Toxicities from EGFR Tyrosine Kinase Inhibitors: A Meta-analysis of Clinical Trials of Gefitinib, Erlotinib, and Afatinib in Advanced EGFR-Mutated Non-Small Cell Lung Cancer.
Ding Pei Ni, Lord Sarah J, Gebski Val et al. · J Thorac Oncol · 2017
PMID: 28007626Meta-Analysis
Risk of elevated transaminases in non-small cell lung cancer (NSCLC) patients treated with erlotinib, gefitinib and afatinib: a meta-analysis.
Abdel-Rahman Omar, Ahmed Hoda, ElHalawani Hesham · Expert Rev Respir Med · 2016
PMID: 26558417Meta-Analysis
Afatinib in the treatment of EGFR mutation-positive NSCLC--a network meta-analysis.
Popat Sanjay, Mok Tony, Yang James Chih-Hsin et al. · Lung Cancer · 2014
PMID: 24929780Meta-Analysis
Pragmatic Randomized Study of Afatinib Versus Chemotherapy for Patients With Non-Small Cell Lung Cancer With Uncommon Epidermal Growth Factor Receptor Mutations: ACHILLES/TORG1834.
Miura Satoru, Tanaka Hiroshi, Misumi Toshihiro et al. · J Clin Oncol · 2025
PMID: 40239133RCT
Bioequivalence study of two formulations of afatinib dimaleate tablets in healthy subjects under fasting conditions: A randomized, open-label, single-dose, crossover trial.
Liu Yanping, Lü Lang, Xu Man et al. · Int J Clin Pharmacol Ther · 2024
PMID: 39157917RCT
Afatinib maintenance therapy following post-operative radiochemotherapy in head and neck squamous cell carcinoma: Results from the phase III randomised double-blind placebo-controlled study BIB2992ORL (GORTEC 2010-02).
Racadot Séverine, Thennevet Isabelle, Ouldbey Yaelle et al. · Eur J Cancer · 2023
PMID: 36434888RCT
A randomized, open-label, two-cycle, two-crossover phase I clinical trial comparing the bioequivalence and safety of afatinib and Giotrifin healthy Chinese subjects.
Liu Guangwen, Xue Jinling, Wang Yanli et al. · J Cancer Res Clin Oncol · 2023
PMID: 35771264RCTFull text (PMC)
Randomized phase II study of preoperative afatinib in untreated head and neck cancers: predictive and pharmacodynamic biomarkers of activity.
Marret Grégoire, Temam Stéphane, Kamal Maud et al. · Sci Rep · 2023
PMID: 38110561RCTFull text (PMC)
Pharmacokinetic and Safety Comparison of 2 Afatinib Dimaleate Tablets in Healthy Chinese Volunteers Under Fasted Conditions: A Randomized, Open-Label, 2-Period, Single-Dose Crossover Study.
Shi Ping, Jiang Xin, Tao Ye et al. · Clin Pharmacol Drug Dev · 2022
PMID: 35794080RCT

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Afatinib (substance)
SNOMED CT
703579002
UMLS CUI
C2987648
RxNorm CUI
1430438
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.

Clinical Data

This intervention maps to 2 entities in the Ltrl knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
4
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.