Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Pa… (NCT03452592) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients With T790M
Stopped: Indications have been approved for marketing
China220 participantsStarted 2018-04-30
Plain-language summary
This study is conducted to evaluate the efficacy and safety of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring T790M mutation
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1.Male or female, aged at least 18 years.
* 2.Histologically or cytologically confirmed, and locally advanced or metastatic NSCLC, who are not suitable for surgery /radiotherapy.
* 3.Patients who have disease progression after continuous previous treatment of 1st/2nd-generation EGFR TKIs (evaluation according to imaging evidence, judged by research center) will be recruited and primary T790M mutation patients are allowed to have received no EGFR-targeting therapy before detection.
* 4.The tissue/cell specimen collected from patients who have received the recent treatment (either TKI or chemotherapy) progression should be confirmed to T790M positive mutation by the detection of central laboratory, while no specimen collection requirements for the primary T790M mutation patients.
* 5\. ECOG performance status of 0 to 2. Life expectancy of at least 12 weeks.
* 6\. At least one measurable lesion by CT or MRI. The measureable lesion should receive no local treatments, such as, radiotherapy. If the lesions located at the regions which were previously treated are confirmed to progress, they can be chosen as lesion according to RECIST Version 1.1.
* 7\. Organ function must meet the following requirements (patients should receive no blood transfusion, blood product, hematopoietic stimulating factors, and albumin):
* Absolute neutrophil count \>= 1.5 x 109/L, Platelet count \>= 75 x109/L, Haemoglobin \>= 90 g/L;
* Alanine aminotransferase/Aspartate aminotran…
What they're measuring
1
Objective response rate of Alflutinib
Timeframe: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks