This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6,586
Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.
Time frame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Percentage of Participants With Disease Control According to RECIST
Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (\<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.
Time frame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Percentage of Participants by Best Overall Response According to RECIST
Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but \<20% increase in sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is \<1) with each type of best overall response was reported.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Tirana, Albania
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Córdoba, Argentina
Unnamed facility
La Plata, Argentina
Unnamed facility
Salta, Argentina
Unnamed facility
Santa Fe, Argentina
...and 533 more locations
Time frame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Percentage of Participants With Death or Disease Progression According to RECIST
Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.
Time frame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Progression-Free Survival (PFS) According to RECIST
Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.
Time frame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Percentage of Participants Who Died
The percentage of participants (in nearest integer) who died from any cause was reported.
Time frame: Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Overall Survival (OS)
OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Time frame: Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter