This is a phase II trial in patients with locally advanced or metastatic non-small cell lung cancer harboring HER2 gene abnormalities （amplification or overexpression）with a performance status of 0 to1 who are planned to receive first-line treatment or who have falied the first-line treatment
Absolute neutrophil count ≥ 1,500/mcL
Platelet count > 90,000/mcL 19
Hemoglobin ≥ 9 g/dL (allow for blood transfusion)
Creatinine ≤ 1.5 × ULN
1. Have previously received treatment with anti-HER2 drugs, including large molecule antibodies, TKIs, ADCs, etc.; 2. Have a history of interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis after using steroids, or have active non-infectious pneumonia with interstitial lung changes during the screening period, active pulmonary tuberculosis, pneumoconiosis, or having ≥2 grade other types of pneumonia, or severe impairment of lung function (FEV1 or DLCO or DLCO/VA as a percentage of the predicted value is less than 40%) confirmed by lung function tests, etc.; 3. Have experienced arterial/deep vein thrombosis events within 6 months before treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.; 4. Have ≥2 grade myocardial ischemia or myocardial infarction, arrhythmias (including QTcF ≥ 450ms (male), QTcF ≥ 470ms (female), and ≥2 grade congestive heart failure (New York Heart Association (NYHA) classification), left ventricular ejection fraction (LVEF) < 50%; angina pectoris requiring anti-myocardial ischemia drugs; clinically significant heart valve disease); 5. Have active autoimmune diseases or autoimmune disease history, including but not limited to Crohn's disease, ulcerative colitis, autoimmune hepatitis/enteritis/vasculitis/renalitis, etc., except for the following situations: ① Controllable type I diabetes; ② Hypothyroidism controlled by hormone replacement therapy; ③ Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis); ④ Other diseases that are expected not to recur (such as asthma that has been cured in childhood); 6. Need systemic or local use of immunosuppressants to achieve the purpose of immunosuppression and still need to continue using them within 2 weeks before randomization; 7. Have pleural effusion (thoracic cavity, abdominal cavity or pericardial cavity) with repeated drainage to relieve clinical symptoms (judged by the investigator), or have received pleural effusion drainage for therapeutic purposes within 2 weeks before treatment; 8. Have symptomatic or progressive CNS metastasis or cancerous meningitis, with diffuse dissemination; Have a history of brain metastasis and if the subject is clinically stable, can be considered for inclusion.
Single group
Trastuzumab Rezetecan
Drug4.8 mg/kg Intravenous injection until disease progression
ivonescimab
Drug20 mg/kg Intravenous injection until disease progression
Progression free survival
The time from the first treatment to disease progression or death due to any cause (whichever occurs first)
Duration of Response
The time from the first assessment of the tumor as being in an objective remission (PR or CR) to the first assessment of disease progression (PD) or death due to any cause prior to PD;
Objective Response Rate
The proportion of patients with the best overall therapeutic effect of CR and PR
Overall survival
The time from the first trial treatment to death due to any cause
Incidence and severity of adverse events (AEs)
Overall incidence of AEs; the incidence of grade 3 or above AEs; the incidence of severe adverse events (SAE); the incidence of drug-related AEs; the incidence of AEs resulting in permanent withdrawal of drugs; the incidence of AEs leading to dose adjustment
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
