Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age 18 to 75 years old (inclusive), Female or male
2. Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
3. Previously treated by EGFR-TKI；
4. At least one measurable tumor lesion according to RECIST v1.1
5. ECOG performance score of 0-1;
6. Expected survival time ≥ 12 weeks;
7. Adequate bone marrow and organ function
8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
You may not be if
1. Subjects with active central nervous system (CNS) metastases.
2. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
3. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
4. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
5. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
6. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
7. Serious cardiovascular disease
8. Presence of severe infection within 4 weeks prior to first dose of study drug
9. Arterial/venous thrombotic events within 3 months prior to the first study dose
10. History of immunodeficiency, including a positive HIV test
11. Presence of active hepatitis B or C;
12. History of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.
Clareo Health | A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC
