To Evaluate the Efficacy and Safety of Anrotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer

Phase 2

Not yet recruiting

• Conditions: Event-free Lifetime
• Interventions: Drug: Anlotinib

• Registration Number: NCT06352008
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-08
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Study Start: 2024-07-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experiment	Anlotinib	-

Primary Outcome Measures

Name	Time	Method
EFS	2year

Trial Locations

Locations (1)

Tianiin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, China