PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC

AstraZeneca

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02777658

D5160R00005

Details and patient eligibility

About

The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Primary Study Cohort

• Provision of written informed consent (patient consent should be within 6 weeks of disease progression, defined elsewhere as the Index Date)
• Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
• Patients with prior confirmed EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC - Patients who developed resistance to an EGFR-TKI due to any other phenotypic/histologic transformations (e.g., small-cell lung cancer, EMT) or other mutations (e.g., HER2, MET amplifications) at the index-date will be eligible for participation in this study as long as they have prior confirmed diagnosis of EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC
• Patients who have progressed on or after EGFR-TKI therapy (i.e., gefitinib, erlotinib or afatinib) within the patient selection period

Inclusion Criteria - Secondary Study Cohort

• Provision of written informed consent (patient consent should be within 6 weeks of NSCLC diagnosis, defined elsewhere as the Index Date)
• Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
• Patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC during the patient selection period. The de-novo T790M mutation can be alone or in combination with other mutations (e.g., L858R and T790M).

Exclusion Criteria - Primary and Secondary Study Cohorts

• Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.

Trial design

169 participants in 2 patient groups

Primary Study Cohort

Description:

Patients with prior confirmed EGFR mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor) therapy

Secondary Study Cohort

Description:

Patients diagnosed with de-novo (wild-type) EGFR T790M mutation-positive (alone or in combination with other mutations) locally advanced or advanced NSCLC