Inetetamab in Combination With Pyrotinib in HER2 Mutant or Amplified Advanced Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, open-label study to evaluate the safety and the efficacy of inetetamab in combination with pyrotinib in patients in HER2 mutant or amplified patients with advanced non-small cell lung cancer

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

1. Age over 18;

2. Histologically or cytologically documented metastatic NSCLC, HER2 activation amplification or mutation stage IIIB-IV NSCLC patient;

3. At least 1 measurable lesion according to RECIST 1.1;

4. ECOG score 0 or 1;

5. Life expectancy of at least 3 months;

6. Within one week before admission, blood routine examination was basically normal:

1. hemoglobin ≥90g/L or ≥5.6mmol/L;

2. neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L;

3. platelet count (PLT) ≥ 100 × 10 ^ 9 / L;

4. Liver and kidney function tests were basically normal within one week before enrollment;

5. total bilirubin (TBIL) ≤ 1.5 × upper limit of normal value (ULN);

6. alanine aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln);

7. serum creatinine ≤ 1.5 × ULN;

8. Partially activated thrombin time(APTT)≤ 1.5 × ULN;

7. For fertile women had negative blood pregnancy tests 7 days before screening;

8. willing to participate and sign the informed consent in person.

Exclusion Criteria:

1. Patients who have received anti-HER2 monoclonal antibody therapy;

2. Have received chemotherapy, biotherapy, targeted therapy, immunotherapy and other anti-tumor therapies within 4 weeks prior to the first use of the study drug including: oral small molecule targeted drugs within 2 weeks prior to the first use of the study drug or within 5 half-lives of known drugs (depending on the time);Radiotherapy was performed within 2 weeks prior to the first administration of the study drug;

3. Have received other clinical study drugs within 4 weeks prior to the first study drug administration;

4. Patients who underwent major surgery within 4 weeks prior to the first dosing of the study drug(except needle biopsy or significant trauma);

5. Those who have been known to have allergic history to the drug components of this regimen;

6. Study drugs that had used a CYP3A4 inhibitor, inducer, or a narrow therapeutic window with a CYP3A4-sensitive substrate ,P-ep strong inducer and inhibitor within 14 days before first administration;

7. The adverse reactions of previous antitumor therapy have not recovered to CTCAE 5.0 grade 1(Hair loss and other toxicities were excluded for which the researchers judged no safety risk);

8. Patients with central nervous system metastasis and clinical symptoms;

9. History of immunodeficiency, including positive HIV test, or suffering from other acquired, congenital immunodeficiency diseases, or history of organ transplantation;

10. Active hepatitis B (HBV virus titer 1000 copies /ml or 200IU/ml);Hepatitis C virus, syphilis infection;

11. Severe heart disease or discomfort, including, but not limited to, the following:

complete left bundle branch block or degree atrioventricular block, history of myocardial infarction, angioplasty, coronary artery bridging, patients with prolonged QT/QTc interval at baseline (QTcF men >450 ms, women >480ms), significant ventricular arrhythmias (such as ventricular tachycardia), history of heart failure or systolic dysfunction (LVEF < 50%), cardiac failure, New York College of Cardiology (NYHA) grade II or higher, uncontrolled hypertension (systolic blood pressure > 180 mmHg ), history or current history of cardiomyopathy that the investigator judged to have an impact on the study;

12. Inability to swallow medications orally, or that the investigator determines severely affect gastrointestinal absorption;

13. Other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma or in situ cervical cancer and/or breast cancer;

14. Any history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or evidence of clinically active interstitial lung disease;

15. Patients with a history of other serious systemic diseases who were judged by the investigator to be unsuitable for clinical trials;

16. Alcohol or drug dependence;

17. Have a clear history of neurological or mental disorders, including epilepsy or dementia;

18. Pregnant and/or breastfeeding;

19. Any other reason the investigator considers the patient is not suitable to participate in the study.