Clinical trial NCT06352008: To Evaluate the Efficacy and Safety of Anrotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer
Official title: To Evaluate the Efficacy and Safety of Anrotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Event-free Lifetime
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the effectiveness of anrotinib hydrochloride capsule in postoperative non-pCR non-small cell lung cancer patients with adjuvant intensive therapy


Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
2. ≥18 years old (calculated by the date of signing the informed consent); Both men and women; ECOG score 0\~1; Expected survival ≥3 months;
3. Patients with stage IIA-IIIA NSCLC who had previously received PD-1/PD-L1 inhibitors combined with chemotherapy neoadjuvant therapy and underwent R0 resection for curative purposes before surgery (note: the disease was presented in the American Joint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) 8th edition of lung cancer TNM staging);
4. For patients who did not achieve pathological complete response after PD-1/PD-L1 inhibitor combined with chemotherapy neoadjuvant treatment, and the time between the first trial medication after surgery was required to be 4-12 weeks;
5. The main organs function well and meet the standards;
6. Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.

Exclusion Criteria:

1. Have had or are currently suffering from other malignant tumors within 5 years. The following two conditions can be included: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)\];
2. Subjects are known to have genetic abnormalities that have been approved for targeted drug therapy (non-squamous cell carcinoma subjects are required to have EGFR or ALK gene tested or provide previous test reports during the screening period)
3. Cardiovascular and cerebrovascular abnormalities:

   1. Patients with past or existing heart failure, degree II or higher heart block;
   2. Past or present myocardial infarction or unstable angina pectoris, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
   3. Occurrence of arteriovenous thrombosis/cancer embolus events within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction requiring clear diagnosis), vascular embolism (including deep vein thrombosis, arterial thrombosis, pulmonary embolism, etc.);
4. Participated in other drug clinical trials within the past 30 days;
5. Within 2 weeks before starting the administration, it has been treated with Chinese patent medicines (including compound Cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Bruceae oil injection/capsule, Xiaoaipingtablet/injection, hualbufatin capsule, etc.) with anti-tumor indications specified in the NMPA approved drug instructions;
6. Received major surgery other than radical resection of lung cancer within 4 weeks prior to initiation of administration; According to the investigator, the patient was not eligible to participate in this clinical study for other reasons.

Primary outcomes:
measure: EFS
timeFrame: 2year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianiin Medical University Cancer Institute & Hospital
Study officials:
References: