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Recruiting Phase 2

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

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About this study

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

Condition
Non-Small Cell Lung Cancer
Tested
Anlotinib
Sponsor
Tianjin Medical University Cancer Institute and Hospital

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Study condition: Non-Small Cell Lung Cancer
  • 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.

Exclusion 11

  • 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.

Where

1 site, 1 recruiting

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.