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Trial record 1 of 1 for:    NCT02625168
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Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC

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ClinicalTrials.gov Identifier: NCT02625168
Recruitment Status : Completed
First Posted : December 9, 2015
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Victor H.F. Lee, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Afatinib Drug: Erlotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Afatinib in Patients With EGFR-mutated Metastatic Non-small-cell Lung Cancer Previously Responsive to First-generation Tyrosine-kinase Inhibitors and Chemotherapy
Study Start Date : January 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Afatinib
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
Afatinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal
Other Name: Gilotrif

Drug: Erlotinib
Erlotinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal
Other Name: Tarceva

Experimental: Erlotinib
Erlotinib 150mg daily until radiologically documented disease progression, intolerable side effects as judged by investigators or patient withdrawal.
Drug: Afatinib
Afatinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal
Other Name: Gilotrif

Drug: Erlotinib
Erlotinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal
Other Name: Tarceva




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 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 ]
    Time interval between date of start of afatinib or erlotinib to date of disease progression or death whichever comes earlier


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Through study completion, an average of 12 months ]
    Percentage of patients who derive objective response after drug treatment as judged by RECIST 1.1

  2. Overall survival [ Time Frame: From date of start of study medication until the date of death from any cause, assessed up to 100 months ]
    Time interval between date of start of afatinib/erlotinib and date of death from any cause

  3. Toxicity profiles [ Time Frame: Through study completion, an average of 12 months ]
    Adverse events or serious adverse events after afatinib/erlotinib



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625168


Locations
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Hong Kong
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Victor Lee, MD Department of Clinical Oncology, The University of Hong Kong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Victor H.F. Lee, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02625168    
Other Study ID Numbers: Version 1
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by Dr. Victor H.F. Lee, The University of Hong Kong:
Afatinib
Erlotinib
Metastatic non-small cell lung cancer
Efficacy
Safety
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action