This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason
Unnamed facility
Budapest, Hungary
Unnamed facility
Budapest, Hungary
Unnamed facility
Debrecen, Hungary
Progression-Free Survival (PFS)
PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.
Time frame: Baseline to progressive disease or death (up to 34 months)
Percentage of Participants With Best Overall Response (BOR)
BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than \[\<\] 10 millimeters \[mm\] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (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.
Time frame: Baseline to progressive disease or death (up to 34 months)
Percentage of Participants Who Were Alive at 1 Year
Time frame: 1 Year (12 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Deszk, Hungary
Unnamed facility
Farkasgyepű, Hungary
Unnamed facility
Gyula, Hungary
Unnamed facility
Mátraháza, Hungary
Unnamed facility
Mosonmagyaróvar, Hungary
Unnamed facility
Nyíregyháza, Hungary
Unnamed facility
Pécs, Hungary
...and 13 more locations