A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 3

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Erlotinib

• Registration Number: NCT01667562
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-20
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-17
• Primary Completion: 2017-09-07
• Study Completion: 2017-09-07
• Results First Submitted: 2018-08-23
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-02
• Last Update Submitted: 2019-12-02
• Results First Posted: 2019-12-20
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
• Measurable disease according to RECIST
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy greater than or equal to (>/=) 12 weeks
• Adequate hematological, liver and renal function
• Participants with asymptomatic and stable cerebral metastases receiving medical treatment

Exclusion Criteria

• Previous chemotherapy or treatment against EGFR for metastatic disease
• Treatment with an investigational agent less than 3 weeks before enrollment
• History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
• Participants with symptomatic cerebral metastases
• Any significant ophthalmologic abnormality
• Unstable systemic disease
• Coumarins use
• Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
• Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
• Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erlotinib	Erlotinib	Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)	Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)	Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants With Objective Response as Assessed by RECIST v 1.1	Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)	Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Proportion of Participants With Disease Control as Assessed by RECIST v 1.1	Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)	Disease control was defined as objective response or stable disease (SD) for at least 6 weeks. OR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of CR and PR four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations	Screening up to approximately 7 days	Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21.
Percentage of Participants With Adverse Events	Baseline up to approximately 4 years and 9 months	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)	Baseline and end of study (approximately 4 years and 9 months)	The domains in the Quality of life score using the Functional Assessment of Cancer Therapy Lung (FACT-L) include physical, social/family, emotional, and functional well-being, and a lung cancer subscale include symptoms, cognitive function and regret of smoking. Minimum and maximum value of the scale is 0 and 4, respectively. Higher score indicate better health state.

Trial Locations

Locations (4)

Clinical Center Nis; Clinic for pulmonary diseases Knez Selo; 🇷🇸 Nis, Serbia

Clinical Center Bezanijska Kosa; Oncology; 🇷🇸 Belgrade, Serbia

Clinic for Pulmonology, Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Institute for pulmonary diseases of Vojvodina; 🇷🇸 Sremska Kamenica, Serbia