A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
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|ClinicalTrials.gov Identifier: NCT01260181|
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : October 26, 2018
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Squamous Non-Small Cell Lung Cancer||Drug: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.
Erlotinib 150 mg tablet will be given orally daily.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
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
|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|
|Study Director:||Clinical Trials||Hoffmann-La Roche|