Last updated: May 20, 2023
Sponsor: Guangdong Provincial People's Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Surgery
Treatment
Lorlatinib
Clinical Study ID
NCT05740943
LORIN
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: absolute valueof 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 normal value,aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit ofnormal value (if liver metastasis, ≤ upper limit of normal value 5 times), serumcreatinine ≤ 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 to takeeffective contraceptive measures;
- Patients with low compliance or willingness to take the drugs and surveillance.
Study Design
Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Lorlatinib
Phase: 2
Study Start date:
March 15, 2023
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
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