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

NCT06352008 | Recruiting Phase 2

• 1 other identifier: E20230553
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival (EFS)

  Defined as the time from the first dose administration to the occurrence of any of the following "events": 1. Non-small cell lung cancer recurrence/metastasis confirmed by pathology or imaging; 2. Disease progression; 3. All-cause death (whichever occurs first).

  2 years

Study Arms (1)

experiment

EXPERIMENTAL

Drug: Anlotinib

Interventions

Anlotinib DRUG

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.

experiment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
• ≥18 years old (calculated by the date of signing the informed consent); Both men and women; ECOG score 0\~1; Expected survival ≥3 months;
• 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);
• 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;
• The main organs function well and meet the standards;
• 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.

You may not qualify if:

• 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 \[Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)\];
• 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)
• Cardiovascular and cerebrovascular abnormalities:
• Patients with past or existing heart failure, degree II or higher heart block;
• Past or present myocardial infarction or unstable angina pectoris, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
• 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.);
• Participated in other drug clinical trials within the past 30 days;
• 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;
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zhansheng

CONTACT

008618526812877; 18526812877@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

CN (1)