Phase
Condition
Surgery
Treatment
Lorlatinib
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age :18 Years to 75 Years;
ECOG physical score 0-2 points; expected survival time ≥ 1 year;
Pathologically confirmed diagnosis with Stage III NSCLC which harbored ALK fusiondetected by next generation sequencing (NGS) or immunohistochemistry (IHC) with orwithout FISH. Suspected N2 (station 2/4/7) for stage III disease should be confirmedby either mediastinoscopy or EBUS.
At least one measurable target lesion according to the RECIST 1.1 standard;
The main organ function meets the following criteria: 1) blood routine: absolutevalue of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g /L; 2) blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normalvalue, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upperlimit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times),serum creatinine ≤ 1.5 times the upper limit of normal;
Subjects voluntarily joined the study and signed informed consent, with goodcompliance to follow-up.
Exclusion
Exclusion Criteria:
Stage I, stage II and metastatic stage IV NSCLC;
Histologically confirmed small cell lung cancer (including lung cancer mixed withsmall cell lung cancer and non-small cell lung cancer);
Patients who have previously used any other anti-tumor drugs or receivedsurgery/radiotherapy;
Patients with any underlying disease that investigators consider it may affectpatient's prognosis including sever cardiovascular, pulmonary disease or seriousinfections.
Clinically obvious gastrointestinal abnormalities, which may affect the intake,transport or absorption of drugs (such as inability to swallow, chronic diarrhea,intestinal obstruction, etc.), or patients with total gastrectomy;
Pregnant or lactating women; those who have fertility are unwilling or unable totake effective contraceptive measures;
Patients with low compliance or willingness to take the drugs and surveillance.
Study Design
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijin 7578932, Beijin 100730
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou 1809858, Guangdong 1809935 510080
ChinaSite Not Available
Guangzhou Twelfth People's Hospital
Guangzhou 1809858, Guangdong 1809935
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha 1815577, Hunan 1806691 410011
ChinaSite Not Available

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