Clinical trial

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

Name

D5160C00042

Description

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 arms

Trial start

2016-12-23

Estimated PCD

2018-10-24

Trial end

2018-10-24

Status

Completed

Phase

Early phase I

Treatment

T790M+ Testing

The patient will need to have T790M+ testing

Arms:

AZD9291

Baseline Visit Blood & Urine Testing

Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria

Arms:

AZD9291

Baseline ECG

ECG to ensure absence of any cardiac abnormality

Arms:

AZD9291

Visual Slit-Lamp Testing

Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms

Arms:

AZD9291

AZD9291 Dosing

Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)

Arms:

AZD9291

Plasma AZD9291 testing

The patient will need to have plasma AZD9291 testing before treatment

Arms:

AZD9291

Size

256

Primary endpoint

Concordance

Up to 6 months

PFS Using Investigator Assessments According to 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

Eligibility criteria

Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Adults (according to China regulations for age of majority) 3. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy. 4. Patients who have progressed following prior therapy with an EGFR-TKI agent. Exclusion Criteria: 1. Patients who disagree to participate this study. 2. Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 256, 'type': 'ACTUAL'}}

Updated at

2024-03-04

1 organization

1 product

1 indication

Product

AZD9291

Indication

lung cancer

Organization

AstraZeneca