First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting

NCT04391283 | Unknown DMC FDA Drug

• 1 other identifier: Osimertinib-RWE-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The results of phase III FLAURA study showed a significant PFS benefit for first-line Osimertinib versus standard EGFR-TKIs in patients with EGFR mutation-positive NSCLC, the median PFS was 18.9 months and 10.2 months, respectively. However, only 136 Chinese patients were enrolled in FLAURA study. The objectives of this study are to assess the efficacy and safety of Osimertinib in a real world setting in Chinese patients with locally advanced or metastatic, treatment naïve, epidermal growth factor receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung; Epidermal Growth Factor Receptor mutation; Osimertinib; Real World evidence; non-interventional

Outcome Measures

Primary Outcomes (1)

• Time to discontinuation (TTD)

  Time to discontinuation (TTD), is defined as the time from the date of first dose of Osimertinib in this study until the date of Osimertinib discontinuation for any reason including disease progression, treatment toxicity, death or other reason as recorded in CRF. Subjects who are still on treatment at the time of analysis will be censored at the date of last dose received. Lost to follow-up patients will be censored at last documented contact with patient status "on treatment".

  from the date of first dose of Osimertinib in this study until the date of Osimertinib discontinuation for any reason including disease progression, treatment toxicity, death or other reason as recorded in CRF, assessed up to 36 months.

Secondary Outcomes (5)

• Progression-free survival (PFS) and Progression-free survival rate (PFS rate)

  from the date of first dose of Osimertinib in this study until the date of disease progression, assessed up to 36 months.

• Objective Response Rate (ORR) and Disease Control Rate (DCR)

  from the date of first dose of Osimertinib, assessed up to 6 months.

• Overall survival rate (OS rate)

  from the date of first dose of Osimertinib in this study until the death of patients,assessed up to 48 months.

• de novo T790M mutation rate

  the baseline and at the time of progression, assessed up to 36 months.

• Adverse events/Serious adverse events

  from the date of first dose of Osimertinib in this study assessed up to 36 months.

Interventions

Osimertinib DRUG

The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity according to the prescription information and clinical practice. It can be taken with or without food at the same time each day.

Also known as: TAGRISSO

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

The patients with locally advanced/metastatic, EGFR mutation-positive NSCLC who are intent to be prescribed Osimertinib as the first line treatment are eligible to be the study target population. Base on the current clinical practice, it is estimated that the brain scans could be performed to approximately 350 patients at the baseline, approximately 200 patients' tissue or blood sample could be available at the baseline for de novo T790M analysis, and few patients with uncommon EGFR mutation, and/or patients with PS 2-3 could be included base on the current CSCO lung cancer guideline and clinical practice.

You may qualify if:

• Ability to provide informed consent, complete all study assessments and have complete medical record;
• Histologically or cytologically documented locally advanced, metastatic NSCLC, which are not amenable to curative surgery or radiotherapy;
• With confirmation of the presence of the EGFR mutation.
• Patients must be treatment- naïve for locally advanced or metastatic NSCLC.
• Age ≥ 18 years
• Patients who plan to receive Osimertinib monotherapy as the initial first line treatment based on physician's medical judgement.

You may not qualify if:

• Patients who will be or were involved in any other interventional anti-tumour clinical studies for locally advanced/metastatic NSCLC currently or previously
• Any concomitant condition evaluated by physicians which is not suitable for Osimertinib treatment.
• Patients who have received the first dose of Osimertinib before the signature of ICF won't be allowed to enroll in.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• AstraZeneca: collaborator

Study Sites (1)

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (10)

• Goss G, Tsai CM, Shepherd FA, Bazhenova L, Lee JS, Chang GC, Crino L, Satouchi M, Chu Q, Hida T, Han JY, Juan O, Dunphy F, Nishio M, Kang JH, Majem M, Mann H, Cantarini M, Ghiorghiu S, Mitsudomi T. Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1643-1652. doi: 10.1016/S1470-2045(16)30508-3. Epub 2016 Oct 14.

  PMID: 27751847 BACKGROUND

• Zhou C. Lung cancer molecular epidemiology in China: recent trends. Transl Lung Cancer Res. 2014 Oct;3(5):270-9. doi: 10.3978/j.issn.2218-6751.2014.09.01.

  PMID: 25806311 BACKGROUND

• Shi Y, Au JS, Thongprasert S, Srinivasan S, Tsai CM, Khoa MT, Heeroma K, Itoh Y, Cornelio G, Yang PC. A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER). J Thorac Oncol. 2014 Feb;9(2):154-62. doi: 10.1097/JTO.0000000000000033.

  PMID: 24419411 BACKGROUND

• Arcila ME, Oxnard GR, Nafa K, Riely GJ, Solomon SB, Zakowski MF, Kris MG, Pao W, Miller VA, Ladanyi M. Rebiopsy of lung cancer patients with acquired resistance to EGFR inhibitors and enhanced detection of the T790M mutation using a locked nucleic acid-based assay. Clin Cancer Res. 2011 Mar 1;17(5):1169-80. doi: 10.1158/1078-0432.CCR-10-2277. Epub 2011 Jan 19.

  PMID: 21248300 BACKGROUND

• Jenkins S, Yang JC, Janne PA, Thress KS, Yu K, Hodge R, Weston S, Dearden S, Patel S, Cantarini M, Shepherd FA. EGFR Mutation Analysis for Prospective Patient Selection in Two Phase II Registration Studies of Osimertinib. J Thorac Oncol. 2017 Aug;12(8):1247-1256. doi: 10.1016/j.jtho.2017.05.002. Epub 2017 May 17.

  PMID: 28527899 BACKGROUND

• John T, Akamatsu H, Delmonte A, Su WC, Lee JS, Chang GC, Huang X, Jenkins S, Wu YL. EGFR mutation analysis for prospective patient selection in AURA3 phase III trial of osimertinib versus platinum-pemetrexed in patients with EGFR T790M-positive advanced non-small-cell lung cancer. Lung Cancer. 2018 Dec;126:133-138. doi: 10.1016/j.lungcan.2018.10.027. Epub 2018 Nov 1.

  PMID: 30527177 BACKGROUND

• Reungwetwattana T, Nakagawa K, Cho BC, Cobo M, Cho EK, Bertolini A, Bohnet S, Zhou C, Lee KH, Nogami N, Okamoto I, Leighl N, Hodge R, McKeown A, Brown AP, Rukazenkov Y, Ramalingam SS, Vansteenkiste J. CNS Response to Osimertinib Versus Standard Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Patients With Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 28:JCO2018783118. doi: 10.1200/JCO.2018.78.3118. Online ahead of print.

  PMID: 30153097 BACKGROUND

• Liu Y, Sun L, Xiong ZC, Sun X, Zhang SL, Ma JT, Han CB. Meta-analysis of the impact of de novo and acquired EGFR T790M mutations on the prognosis of patients with non-small cell lung cancer receiving EGFR-TKIs. Onco Targets Ther. 2017 Apr 24;10:2267-2279. doi: 10.2147/OTT.S133082. eCollection 2017.

  PMID: 28479857 BACKGROUND

• Su KY, Chen HY, Li KC, Kuo ML, Yang JC, Chan WK, Ho BC, Chang GC, Shih JY, Yu SL, Yang PC. Pretreatment epidermal growth factor receptor (EGFR) T790M mutation predicts shorter EGFR tyrosine kinase inhibitor response duration in patients with non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):433-40. doi: 10.1200/JCO.2011.38.3224. Epub 2012 Jan 3.

  PMID: 22215752 BACKGROUND

• Zheng R, Zeng H, Zhang S, Chen W. Estimates of cancer incidence and mortality in China, 2013. Chin J Cancer. 2017 Aug 17;36(1):66. doi: 10.1186/s40880-017-0234-3.

  PMID: 28818111 RESULT

Biospecimen

Retention: NONE RETAINED

Blood Sample Collection and Retention: about 10 mL Whole human blood samples will be collected using streck tube, sent to the NGS lab and plasma will be extracted for storage at -80℃. until test. Tissue Sample Collection and Retention At baseline, fresh tissue samples (or cytological samples) will be collected or 6 slices of tissue sample olefin resections obtained from surgery or 10 slices of tissue samples olefin resection obtained from puncture biopsy will be provide to central laboratory for biomarker analysis. Before tissue sample olefin resection sent to central laboratory, a pathological quality should be conducted to ensure the percentage of tumor cells is greater than 10%. Tissue sample olefin resection will be labeled and put in a box and store at room temperature

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 18, 2020
• Study Start: July 27, 2020
• Primary Completion: April 26, 2022
• Study Completion: December 1, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)