Lorlatinib: Patients were assigned to receive oral lorlatinib at a dose of 100 mg daily in a course of treatment that was measured in cycles of 28 days. 3 cycles of induction treatment will be required for the study.
Study summary
A prospective, single-arm, open-label phase 2 study that evaluates the efficacy and safety of induction Lorlatinib in stage III non-small cell lung cancer and explores the clinical feasibility of dynamic ctDNA and multidisciplinary assessment in guiding local treatments.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 fusion detected by next generation sequencing (NGS) or immunohistochemistry (IHC) with or without FISH. Suspected N2 (station 2/4/7) for stage III disease should be confirmed by 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 value 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 normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit 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 good compliance to follow-up.
Exclusion Criteria:
* Stage I, stage II and metastatic stage IV NSCLC;
* Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
* Patients who have previously used any other anti-tumor drugs or received surgery/radiotherapy;
* Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections.
* 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 take effective contraceptive measures;
* Patients with low compliance or willingness to take the drugs and surveillance.
Primary outcome measure(s)
Pathological Complete Response (pCR) — After surgery (approximately 2 weeks) The pathological complete response is defined as the absence of residual tumor in both lung and regional lymph nodes after induction treatment and radical surgery.
Trial sites (4)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijin
Beijin
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Guangzhou Twelfth People's Hospital
Guangzhou
Guangdong
The Second Xiangya Hospital of Central South University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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