T790M Plasma Testing Methodology Comparison and Clinical Validation
ADELOS
Detect EGFR T790M Mutation in ctDNA of Chinese Advanced/Metastatic NSCLC Patients by Cobas, Super-ARMS, Digital PCR and NGS and Evaluate Clinical Outcomes of T790M Mutation Positive Patients Who Had AZD9291 Monotherapy
1 other identifier
interventional
256
1 country
7
Brief Summary
The aim of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. And to assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 lung-cancer
Started Dec 2016
Shorter than P25 for phase_3 lung-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedStudy Start
First participant enrolled
December 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2018
CompletedResults Posted
Study results publicly available
March 4, 2024
CompletedMarch 4, 2024
February 1, 2024
1.8 years
December 9, 2016
July 11, 2023
March 1, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Concordance
To evaluate concordance of T790M plasma mutation testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS.
Up to 6 months
PFS Using Investigator Assessments According to RECIST v1.1
To assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR- TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms. PFS was defined using Response Evaluation Criteria In Solid Tumors version 1.1(RECIST v1.1).
The time from first dose of AZD9291 in this study until the date of disease progression as recorded in CRF or death (by any cause in the absence of progression), assessed up to 18 months
Secondary Outcomes (3)
Testing Sensitivity, Specificity, PPV, NPV
Up to 6 months.
Overall Response Rate (ORR)
From first patient first CT scan for RECIST assessment, till the last patient last CT scan, up to 22 months.
75% OS Duration
From first patient signed the consent to study completion, up to 22 months.
Study Arms (1)
AZD9291
EXPERIMENTALSingle arm of AZD9291, starting dose of 80mg
Interventions
Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria
Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms
The patient will need to have plasma AZD9291 testing before treatment
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures.
- Adults (according to China regulations for age of majority)
- Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.
- Patients who have progressed following prior therapy with an EGFR-TKI agent.
You may not qualify if:
- Patients who disagree to participate this study.
- Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- TigerMedcollaborator
Study Sites (7)
Research Site
Changchun, 130012, China
Research Site
Chengdu, 610041, China
Research Site
Guangzhou, 510080, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430030, China
Research Site
Wuhan, 430079, China
Research Site
Xi'an, 710038, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- Astrazeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Yilong WU
Guangdong General Hospita
- PRINCIPAL INVESTIGATOR
Zhiyong LIANG
Peking Union Medical College Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2016
First Posted
December 20, 2016
Study Start
December 23, 2016
Primary Completion
October 24, 2018
Study Completion
October 24, 2018
Last Updated
March 4, 2024
Results First Posted
March 4, 2024
Record last verified: 2024-02