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

Last updated: November 17, 2025
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

Anlotinib

Clinical Study ID

NCT06352008
E20230553
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The subjects voluntarily joined the study, signed the informed consent, and thecompliance was good;

  2. ≥18 years old (calculated by the date of signing the informed consent); Both men andwomen; ECOG score 0~1; Expected survival ≥3 months;

  3. Patients with stage IIA-IIIA NSCLC who had previously received PD-1/PD-L1 inhibitorscombined with chemotherapy neoadjuvant therapy and underwent R0 resection forcurative purposes before surgery (note: the disease was presented in the AmericanJoint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) 8thedition of lung cancer TNM staging);

  4. For patients who did not achieve pathological complete response after PD-1/PD-L1inhibitor combined with chemotherapy neoadjuvant treatment, and the time between thefirst 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 usedduring the study period and for 6 months after the end of the study, and that serumor urine pregnancy tests are negative within 7 days prior to study enrollment; Menshould agree that effective birth control must be used during the study period andfor 6 months after the end of the study period.

Exclusion

Exclusion Criteria:

  1. Have had or are currently suffering from other malignant tumors within 5 years. Thefollowing two conditions can be included: other malignancies treated with a singleoperation, achieving continuous 5-year disease-free survival (DFS); Cured cervicalcarcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basalmembrane)];

  2. Subjects are known to have genetic abnormalities that have been approved fortargeted drug therapy (non-squamous cell carcinoma subjects are required to haveEGFR or ALK gene tested or provide previous test reports during the screeningperiod)

  3. Cardiovascular and cerebrovascular abnormalities:

  4. Patients with past or existing heart failure, degree II or higher heart block;

  5. Past or present myocardial infarction or unstable angina pectoris, clinicallysignificant supraventricular or ventricular arrhythmias requiring treatment orintervention;

  6. Occurrence of arteriovenous thrombosis/cancer embolus events within 6 months,such as cerebrovascular accident (including transient ischemic attack, cerebralhemorrhage, cerebral infarction requiring clear diagnosis), vascular embolism (including deep vein thrombosis, arterial thrombosis, pulmonary embolism,etc.);

  7. Participated in other drug clinical trials within the past 30 days;

  8. Within 2 weeks before starting the administration, it has been treated with Chinesepatent medicines (including compound Cantharides capsule, Kangai injection,Kanglaite capsule/injection, Aidi injection, Bruceae oil injection/capsule,Xiaoaipingtablet/injection, hualbufatin capsule, etc.) with anti-tumor indicationsspecified in the NMPA approved drug instructions;

  9. Received major surgery other than radical resection of lung cancer within 4 weeksprior to initiation of administration; According to the investigator, the patientwas not eligible to participate in this clinical study for other reasons.

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: Anlotinib
Phase: 2
Study Start date:
July 01, 2024
Estimated Completion Date:
June 01, 2027

Connect with a study center

  • Tianiin Medical University Cancer Institute & Hospital

    Tianjin,
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin 1792947,
    China

    Active - Recruiting

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