A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
- Registration Number
- NCT01260181
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Locally advanced or metastatic NSCLC with EGFR mutations
- Measurable disease according to RECIST criteria
- Adequate hematological, renal and liver function
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Erlotinib Erlotinib Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1 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.
Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population 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 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).
Overall Survival 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 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.
Trial Locations
- Locations (9)
Hospital Geral; Servico de Pneumologia
🇵🇹Coimbra, Portugal
IPO de Lisboa; Servico de Pneumologia
🇵🇹Lisboa, Portugal
Hospital de Santa Maria; Servico de Pneumologia
🇵🇹Lisboa, Portugal
Hospital Pulido Valente; Servico de Pneumologia
🇵🇹Lisboa, Portugal
Hospital de Sao Joao; Servico de Pneumologia
🇵🇹Porto, Portugal
Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
🇵🇹Lisboa, Portugal
Hospital Infante D. Pedro; Servico de Oncologia Medica
🇵🇹Aveiro, Portugal
CHVNG/E_Unidade 1; Servico de Pneumologia
🇵🇹Vila Nova De Gaia, Portugal
IPO do Porto; Servico de Oncologia Medica
🇵🇹Porto, Portugal