Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC

NCT02625168 | Completed Phase 2

• 1 other identifier: Version 1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators prospectively evaluated in this study the efficacy and safety profiles of afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program (CUP), with comparison of our historical cohort who received erlotinib after previous failure to systemic chemotherapy and first-generation EGFR-TKI.

Conditions

Lung Cancer

Keywords

Afatinib; Erlotinib; Metastatic non-small cell lung cancer; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Time interval between date of start of afatinib or erlotinib to date of disease progression or death whichever comes earlier

  From date of start of study medication until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (3)

• Objective response rate

  Through study completion, an average of 12 months

• Overall survival

  From date of start of study medication until the date of death from any cause, assessed up to 100 months

• Toxicity profiles

  Through study completion, an average of 12 months

Study Arms (2)

Afatinib

EXPERIMENTAL

Afatinib 30 or 40 or 50mg daily orally after study recruitment until radiologically documented disease progression, intolerable side effects as judged by investigators or patient withdrawal.

Drug: Afatinib; Drug: Erlotinib

Erlotinib

EXPERIMENTAL

Erlotinib 150mg daily until radiologically documented disease progression, intolerable side effects as judged by investigators or patient withdrawal.

Drug: Afatinib; Drug: Erlotinib

Interventions

Afatinib DRUG

Afatinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal

Also known as: Gilotrif

Afatinib; Erlotinib

Erlotinib DRUG

Erlotinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal

Also known as: Tarceva

Afatinib; Erlotinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who were previously responsive to one line of EGFR tyrosine kinase inhibitor and at least one line of systemic chemotherapy
• Adequate hematological function (ANC \>=1.5 x 10\^9/l, Hb \>=9.0 x 10\^9/l, plt \>=100 x 10\^9/l)
• Adequate renal function (with estimated creatinine clearance \>=50ml/min as determined by Cockcroft-Gault formula)
• Adequate liver function (ALT/AST \<2.5 x upper normal limit or ALT/AST \<5 x upper normal limit in the presence of liver metastasis)
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Evaluable target lesions according to RECIST 1.1 for tumour response assessment
• Patients able to give written consent

You may not qualify if:

• Symptomatic brain metastases requiring steroids/surgery/radiation therapy within 4 weeks of commencement of study medication
• Significant cardiovascular abnormalities
• Significant psychiatric disorders
• Patients who have documented history of interstitial lung disease

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Lee VH, Leung DK, Choy TS, Lam KO, Lam PM, Leung TW, Kwong DL. Efficacy and safety of afatinib in Chinese patients with EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) previously responsive to first-generation tyrosine-kinase inhibitors (TKI) and chemotherapy: comparison with historical cohort using erlotinib. BMC Cancer. 2016 Feb 24;16:147. doi: 10.1186/s12885-016-2201-9.

  PMID: 26911310 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Victor Lee, MD

  Department of Clinical Oncology, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 9, 2015
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

HK (1)