MedDataX Logo

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

NCT ID: NCT02208843

Last Updated: 2018-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-02

Study Completion Date

2017-06-13

Brief Summary

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

The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.

Related Clinical Trials

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

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

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

NCT01953913

Carcinoma, Non-Small-Cell Lung
COMPLETED PHASE3

Neoadjuvant Afatinib Therapy for Potentially Resectable Stage III EGFR Mutation-Positive Lung Adenocarcinoma

NCT04201756

Lung Adenocarcinoma Stage III EGFR Gene Mutation
COMPLETED PHASE2

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

Detailed Description

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

Conditions

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

Carcinoma, Non-Small-Cell Lung

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Afatinib

Afatinib tablet once daily until progression

Group Type EXPERIMENTAL

Afatinib

Intervention Type DRUG

Afatinib tablet once daily until progression

Interventions

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

Afatinib

Afatinib tablet once daily until progression

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
2. Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
3. Measureable disease according to RECIST 1.1.
4. Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
6. Adequate organ function.

Exclusion Criteria

1. More than one line of prior therapy for disease.
2. Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
3. Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
4. Known pre-existing interstitial lung disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Research Center, Alexandria University Hospital

Alexandria, , Egypt

Site Status

National Cancer Institute, Cairo University

Cairo, , Egypt

Site Status

Kasr Al Ainy Hospital

Cairo, , Egypt

Site Status

Nilai Medical Centre

Kampung Baharu Nilai, , Malaysia

Site Status

Baguio General Hospital and Medical Center

Baguio City, , Philippines

Site Status

St. Luke's Medical Center

City of Taguig, , Philippines

Site Status

University Clinical Center, Gdansk

Gdansk, , Poland

Site Status

Specialist Hospital, Szczecin-Zdunowo

Szczecin-Zdunowo, , Poland

Site Status

Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer

Warsaw, , Poland

Site Status

Braila County Emergency Hospital, Medical Oncology

Brăila, , Romania

Site Status

Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

Bucharest, , Romania

Site Status

Sf. Nectarie Oncology Center, Craiova

Craiova, , Romania

Site Status

Regional Oncology Institute of Iasi, Medical Oncology

Iași, , Romania

Site Status

Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.

Belgrade, , Serbia

Site Status

Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol

Kamenitz, , Serbia

Site Status

Clinical Center Kragujevac

Kragujevac, , Serbia

Site Status

Wattanosoth Hospital

Bangkok, , Thailand

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Rajavithi Hospital

Bangkok, , Thailand

Site Status

Songklanagarind Hospital

Songkhla, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt Malaysia Philippines Poland Romania Serbia Thailand

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-001077-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.217

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

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 COMPLETED
Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)
NCT02695290 TERMINATED PHASE4
Observational Study of Afatinib 30 mg Daily
NCT04909073 RECRUITING
Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma
NCT03486509 UNKNOWN PHASE2
Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex
NCT02876081 WITHDRAWN PHASE2
Expanded Access Study of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Non-small Cell Lung Cancer (NSCLC)
NCT01931306 APPROVED_FOR_MARKETING
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]
NCT01003899 COMPLETED PHASE2
Afatinib Expanded Access Program
NCT01649284 APPROVED_FOR_MARKETING
To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation
NCT04132102 UNKNOWN PHASE4
Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients
NCT01415011 COMPLETED PHASE2
The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib
NCT04640870 COMPLETED
Maintaining ERBB Blockade in EGFR-mutated Lung Cancer
NCT02488694 TERMINATED PHASE2
Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings
NCT02440854 COMPLETED
Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA
NCT02629523 COMPLETED PHASE2
Afatinib Genomic Landscape
NCT02491775 TERMINATED
Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation
NCT01746251 UNKNOWN PHASE2
A Phase II Trial of Afatinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus
NCT02353936 UNKNOWN PHASE2
Afatinib With CT and RT for EGFR-Mutant NSCLC
NCT01553942 ACTIVE_NOT_RECRUITING PHASE2
LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
NCT00525148 COMPLETED PHASE2
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
NCT04426825 COMPLETED PHASE2
A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
NCT02108964 COMPLETED PHASE1/PHASE2
A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations
NCT01647711 COMPLETED PHASE1
GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
NCT02047903 COMPLETED
Neoadjuvant Afatinib Combination With Chemotherapy for Stage Ⅱa-Ⅲb NSCLC With EGFR Activating Mutation
NCT04470076 UNKNOWN PHASE2
Study of Apatinib as 3rd/4th Line Treatment in Patients With Advanced Non-Squamous Non-small Cell Lung Cancer Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)
NCT02332512 UNKNOWN PHASE3