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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01667562
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : December 20, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Erlotinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIIb, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
Actual Study Start Date : January 20, 2012
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : September 7, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erlotinib
Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
Drug: Erlotinib
Daily oral doses administered until disease progression or unacceptable toxicity or death.
Other Name: Tarceva

No Intervention: Diagnostic Phase
Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study.



Primary Outcome Measures :
  1. Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) [ Time Frame: 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 :
  1. Proportion of Participants With Objective Response as Assessed by RECIST v 1.1 [ Time Frame: 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.

  2. Proportion of Participants With Disease Control as Assessed by RECIST v 1.1 [ Time Frame: 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.

  3. Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations [ Time Frame: 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.

  4. Percentage of Participants With Adverse Events [ Time Frame: 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.

  5. Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT01667562


Locations
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Serbia
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Center Bezanijska Kosa; Oncology
Belgrade, Serbia, 11080
Clinical Center Nis; Clinic for pulmonary diseases Knez Selo
Nis, Serbia
Institute for pulmonary diseases of Vojvodina
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667562    
Other Study ID Numbers: ML27860
First Posted: August 17, 2012    Key Record Dates
Results First Posted: December 20, 2019
Last Update Posted: December 20, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action