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

NCT04768491 | Unknown FDA Drug

• 1 other identifier: NCC2439
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• progression-free survival

  up to 4 years

• duration of treatment

  up to 4 years

• overall survival

  up to 5 years

Study Arms (1)

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

Interventions

Dacomitinib DRUG

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.

dacomitinib treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with EGFR mutation and advanced NSCLC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample will be taken when each patient were reexamined in hospital

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junling Li, MD

  Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  STUDY DIRECTOR

Central Study Contacts

Puyuan Xing, PhD

CONTACT

+86-10-87788495; xingpuyuan@cicams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 24, 2021
• Study Start: September 1, 2020
• Primary Completion: June 30, 2024
• Study Completion: October 31, 2024
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)