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A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

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: NCT01260181
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : October 26, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Erlotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, 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 : March 31, 2011
Actual Primary Completion Date : September 29, 2017
Actual Study Completion Date : September 29, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erlotinib
Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.
Drug: Erlotinib
Erlotinib 150 mg tablet will be given orally daily.




Primary Outcome Measures :
  1. Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]
    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.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1 [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]
    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.

  2. Overall Survival [ Time Frame: Baseline up to 5 years ]
    Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.

  3. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 5 years ]
    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.

  4. Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population [ Time Frame: Screening (21 days prior to Day 1) ]
    Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21.

  5. Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]
    The response duration was defined as the time of initial response (complete response (CR) /partial response (PR) whichever is first recorded) until documented disease progression. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as 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).



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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:

  • Locally advanced or metastatic NSCLC with EGFR mutations
  • Measurable disease according to RECIST criteria
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Previous chemotherapy or therapy against EGFR for metastatic disease
  • Symptomatic cerebral metastases
  • Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
  • History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  • Concomitant use of coumarins

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): NCT01260181


Locations
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Portugal
Hospital Infante D. Pedro; Servico de Oncologia Medica
Aveiro, Portugal, 3814-501
Hospital Geral; Servico de Pneumologia
Coimbra, Portugal, 3041-801
IPO de Lisboa; Servico de Pneumologia
Lisboa, Portugal, 1099-023
Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
Lisboa, Portugal, 1150-314
Hospital de Santa Maria; Servico de Pneumologia
Lisboa, Portugal, 1600
Hospital Pulido Valente; Servico de Pneumologia
Lisboa, Portugal, 1796-001
IPO do Porto; Servico de Oncologia Medica
Porto, Portugal, 4200-072
Hospital de Sao Joao; Servico de Pneumologia
Porto, Portugal, 4200
CHVNG/E_Unidade 1; Servico de Pneumologia
Vila Nova De Gaia, Portugal, 4434-502
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:
Statistical Analysis Plan  [PDF] March 28, 2014
Study Protocol  [PDF] February 12, 2014

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01260181    
Other Study ID Numbers: ML25434
2010-022509-17
First Posted: December 15, 2010    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
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