CompletedNot Applicable

ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory

China897 participantsStarted 2017-01-16

Plain-language summary

The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
✓. 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.
✓. Patients who consent to provide tumour tissue and/or blood.

Exclusion criteria

✕. Patients who disagree to participate this study.
✕. Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.

What they're measuring

the concordance of T790M mutation testing between the test in central and local labs

Timeframe: within 1 -14 days after enrolled

Trial details

NCT IDNCT02991274

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-06-29

View on ClinicalTrials.gov More Locally Advanced or Metastatic EGFR(+) NSCLC Patients trials