CompletedPhase 2

TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy

South Korea63 participantsStarted 2017-08-11

Plain-language summary

In this trial, anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Age ≥ 20, and patients who understand information about the trial and voluntarily agree to participate in the trial
✓. Histological or cytological confirmation diagnosis of NSCLC and inoperable stage IIIB or IV at the time of study enrolment
✓. Patients with EGFR sensitizing mutation (E19Del, L858R, L861Q, G719X) positive, who had shown clinical benefits (responders (CR or PR) and SD ≥6 months) from EGFR-TKIs and had developed progressive disease following those therapy
✓. ECOG performance status 0-2
✓. Patients in whom T790 mutations are detected in at least one of the samples including tumor tissues, BALF (cell-free DNA), plasma (cell-free DNA), and pleural effusion (cell-free DNA)
✓. At least one measurable lesions according to RECIST v 1.1
✓. Female with childbearing potential (within 1 year of time interval between last menses and the date of informed consent) who use appropriate contraception methods and are not on breast-feeding, and tested negative for pregnancy test or are sure to have a proof for infertility prior to drug initiation
✓. Males willing to use barrier contraception methods during study period (Patients should inform their sexual partners of the use of the allowed contraception methods.)

Exclusion criteria

✕. Patients who were previously treated with any of the drugs targeting T790M mutation such as AZD9291 (Osimertinib), HM61713 (Olmutinib), and CO-1686 (Rociletinib)
✕. Patients currently receiving medications known to be potent inhibitors of CYP3A4 and potent inducers of CYP3A4 (at least 1week prior study enrolment)
✕. Patients who have preexisting or coexisting malignancies in other parts except for effectively treated non-melanoma skin cancer, CIS cervical cancer, DCIS breast cancer, thyroid cancer or malignancies that were effectively treated, have maintained at least 3 years of remission state and can be regarded as completely cured
✕. Patients who have severe or unstable medical conditions such as prior or current clinically significant cardiovascular abnormality in accordance with the investigator's judgment such as uncontrolled hypertension, heart failure (NYHA classification ≥3), unstable angina or uncontrolled arrhythmia, and acute myocardial infarction within 6 months before study enrolment corrected QTcB \>450msec in 12 lead EKG
✕. Patients with current or prior interstitial lung disease
✕. Patients with current or prior uncontrolled gastrointestinal diseases (e.g., crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption) that would preclude adequate absorption of IP.
✕. Patients with active hepatitis B (identified by the presence of HBsAg and/or HBV DNA), active hepatitis C (identified by the presence of HCV RNA), and known human immunodeficiency virus (HIV)
✕. Patients with histories of hypersensitivity to IP or any components of the agent

What they're measuring

ORR

Timeframe: through study completion (43 months)

Trial details

NCT IDNCT03394118

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-11

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