A Spanish Medical Record Review of Clinical Characteristics and Outcomes in Non-small Cell Lung Cancer Participants With EGFR Exon 20 Insertion

Percentage of participants will be reported based on type of EGFR mutation and its variant: EGFR exon 20 insertion or compound mutations.

ORR is defined as the percentage of participants on a given treatment that have at least one partial remission (PR)/complete remission (CR) assessment determination within 3 months after initiation of treatment. CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. ORR will be assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

PFS is defined as the time from treatment start until disease progression (PD) or death. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. PFS will be assessed by RECIST 1.1.

DCR is defined as the percentage of participants on a given treatment that have at least one PR/CR/stable disease (SD) and no PD assessment determination within 3 months after treatment start. CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. DCR will be assessed by RECIST 1.1.

TTF is defined as the time from treatment start until treatment discontinuation due to any reason including toxicity, PD, or death. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. TTF will be assessed by RECIST 1.1.

OS is defined as the time from treatment start until death from any cause or the last follow-up. OS will be assessed by RECIST 1.1.

Health care resources utilization including information related with direct costs (hospitalizations, tests, computed tomography [CT], positron emission tomography [PET], magnetic resonance imaging [MRI]) will be reported.

Treatment-related grade 3 or higher AE will be reported. Treatment-related AE grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

Participants with at least one treatment-related AE will be reported. An AE is defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.

Participants will be reported based on the method of molecular testing to analyze EGFR mutations (for example, polymerase chain reaction [PCR], PCR-reverse transcription [RT], Next-generation sequencing [NGS]).