NCT04768491

Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC

Real-world Study on Sequential Therapy With Dacomitinib as First-line Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 82 (estimated)
• Sponsor: Peking Union Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-interventional, multi-center, ambispective cohort study in real world to describe the effectiveness and safety profile in patients with EGFR mutation-positive advanced NSCLC treated with dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance mutation was developed.

Detailed description

This is a multi-center observational study with both retrospective and prospective data collections to describe the effectiveness and safety of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance in a clinical practice setting. The study will include patients who were or will be diagnosed as advanced NSCLC with EGFR mutation positive and received dacomitinib as first-line treatment followed by second-line 3rd generation EGFR-TKI treatment in multiple tertiary care hospitals after Sep 1st, 2019. Patients' clinical information prior to the study initiation in each hospital will be collected retrospectively through chart review. After the study initiation, new patient enrollment will last till Dec 2022. Patients' clinical care after the study initiation will be followed up prospectively until the end of study. The interval of response evaluation is recommended to be every 2 to 3 months in the treatment period and the interval of follow-up is recommended to be every 2 to 3 months in the post-treatment period till the end of study in the prospective data collection period.

Conditions

• EGFR Activating Mutation
• NSCLC Stage IV
• NSCLC Stage IIIB
• NSCLC, Recurrent

Interventions

Type	Name	Description
DRUG	Dacomitinib	effectiveness and safety profile in patients with EGFR mutation-positive advanced NSCLC treated with dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance mutation was developed.

Timeline

• Start date: 2020-09-01
• Primary completion: 2024-06-30
• Completion: 2024-10-31
• First posted: 2021-02-24
• Last updated: 2021-02-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study