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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC Stage IV; EGFR Activating Mutation; NSCLC Stage IIIB; NSCLC, Recurrent
• Intervention / Treatment: Drug: Dacomitinib

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.

• Study Type: Observational
• Enrollment (Anticipated): 82

Contacts and Locations

• Study Contact: Name: Puyuan Xing, PhD; Phone Number: +86-10-87788495; Email: xingpuyuan@cicams.ac.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Dawei Wu, PhD; Phone Number: +86-10-877888495

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with EGFR mutation and advanced NSCLC

Description

Inclusion Criteria:

• A confirmed diagnosis of locally advanced or metastatic NSCLC.
• The tumor harbored common EGFR mutations (Del19, L858R) at start of first-line treatment
• Age ≥ 18 years
• Had never received any EGFR TKI therapy.
• Patients that treated with dacomitinib (Vizimpro®) as first-line treatment
• Confirmation of the T790M variant after first line dacomitinib treatment and receive any 3rd generation EGFR-TKI as second-line treatment.
• Asymptomatic CNS metastases allowed
• At least one lesion that can be accurately measured at baseline according to the RECIST 1.1, and which is suitable for accurate repeated measurements.
• Start second-line treatment with third generation EGFR TKI no later than 01 JAN2023（>10 month before data cutoff date）
• All eligible patients are required to sign an informed consent before initiating the study

Exclusion Criteria:

• Patients who received drug(s) other than 3rd generation EGFR-TKI as the second-line treatment and/or patients who received drug(s) other than Dacomitinib (Vizimpro®) as the first-line treatment
• Received or currently receiving dacomitinib from any interventional clinical trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dacomitinib treatment; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to treatment failure	To describe the time to treatment failure (TTF) of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC and T790M-aquired resistance in China.	up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	To describe the progression-free survival (PFS) of dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance in China.	up to 4 years
duration of treatment	To describe the duration of treatment (DOT) of dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance respectively in China.	up to 4 years
overall survival	To describe the overall survival (OS) of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC and T790M-aquired resistance in China.	up to 5 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College
• Investigators: Study Director: Junling Li, MD, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: NCC2439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes