A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC

Korábbi kezelés

• Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
• Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
• Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
• Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
• Presence of severe infection within 4 weeks prior to first dose of study drug
• Arterial/venous thrombotic events within 3 months prior to the first study dose

Más betegség

• 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
• Serious cardiovascular disease
• History of immunodeficiency, including a positive HIV test
• Presence of active hepatitis B or C;
• History of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.

Egyéb

• Subjects with active central nervous system (CNS) metastases.

• Age 18 to 75 years old (inclusive), Female or male
• Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
• Previously treated by EGFR-TKI；
• At least one measurable tumor lesion according to RECIST v1.1
• ECOG performance score of 0-1;
• Expected survival time ≥ 12 weeks;
• Adequate bone marrow and organ function
• Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.