A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

An Open-Label Multicenter Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond RECIST Progression in NSCLC Patients Who Harbour EGFR Mutations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310036
• Other study ID #: ML25637
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2011
• Est. completion date: December 30, 2016

Study information

• Verified date: September 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 30, 2016
• Est. primary completion date: February 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants, >/= 18 years of age

• Stage IV or recurrent non-small cell lung cancer (NSCLC)

• Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)

• Measurable disease (at least one lesion >= 10 mm in longest diameter)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Adequate hematological, renal and liver function

Exclusion Criteria:

• Patients with T790M single mutation only

• Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab

• Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease

• Symptomatic or uncontrolled central nervous system (CNS) metastases

• Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast

• Any significant ophthalmologic abnormality

• Pre-existing parenchymal lung disease such as pulmonary fibrosis

• Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
Hong Kong	Princess Margaret Hospital; Oncology	Hong Kong
Hong Kong	Queen Elizabeth Hospital; Clinical Oncology	Hong Kong
Hong Kong	Prince of Wales Hosp; Dept. Of Clinical Onc	Shatin
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Gil Hospital. Gachon University	Incheon
Korea, Republic of	Asan Medical Center; Medical Oncology	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital; Medical Oncology	Seoul
Taiwan	Changhua Christian Hospital; Internal Medicine	Changhua
Taiwan	Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine	Kaohsiung
Taiwan	Veterans General Hospital; Internal Medicine	Kaohsiung
Taiwan	China Medical University Hospital; Pulmonary and Critical Care Medicine	Taichung
Taiwan	Taichung Veterans General Hospital; Dept of Internal Medicine	Taichung
Taiwan	Chi-Mei Medical Centre; Hematology & Oncology	Tainan
Taiwan	National Cheng Kung Uni Hospital; Dept of Hematology and Oncology	Tainan
Taiwan	National Taiwan Uni Hospital; Internal Medicine	Taipei
Taiwan	Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou; Chest Dept	Taoyuan
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Pramongkutklao Hospital; Medicine - Medical Oncology Unit	Bangkok
Thailand	Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival Per RECIST, v. 1.1 (PFS1)	PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.	Approximately 68 months
Secondary	Progression-free Survival Per Investigator (PFS2)	PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.	Approximately 68 months
Secondary	Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R	ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.	Approximately 68 months
Secondary	Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R	DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.	Approximately 68 months
Secondary	Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)	PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.	Approximately 68 months
Secondary	Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R	OS was defined as the time from baseline to the date of death from any cause.	Approximately 68 months
Secondary	Number of Participants With Adverse Events	An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.	Approximately 68 months
Secondary	Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)	This outcome measure was not assessed.	Approximately 68 months