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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Event-free Lifetime
• Intervention / Treatment: Drug: Anlotinib

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhansheng; Phone Number: 008618526812877; Email: 18526812877@163.com

Study Locations

• China
  • Tianjin, China
    • Tianiin Medical University Cancer Institute & Hospital
    • Contact: Phone Number: +008618526812877

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: experiment

Drug: Anlotinib; 12mg once a day, taken orally before breakfast for 2 consecutive weeks and stopped for 1 week. Without special circumstances, it is recommended to take at a fixed time every day; If there is a missing dose during the administration, confirm that the time before the next administration is less than 12 hours, no more refilling. The maximum duration of drug use is tentatively 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
EFS	2year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Zhansheng Jiang

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No