Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

T790M Plasma Testing Methodology Comparison and Clinical Validation
T790M Plasma Testing Methodology Comparison and Clinical Validation

NCT02997501

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Lung Cancer

Interventions: T790M+ Testing, Baseline Visit Blood & Urine Testing, Baseline ECG, Visual Slit-Lamp Testing, AZD9291 Dosing

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (7)
  • Changchun, China
  • Chengdu, China
  • Guangzhou, China
  • Wuhan, China
  • Wuhan, China
  • Wuhan, China
  • Xi'an, China