A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer

Exclusion Criteria26

• There are untreated or active central nervous system (CNS) tumor metastases
• Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration
• Systemic antitumor therapy was performed 4 weeks prior to study initiation
• Prior treatment with antibody-conjugated drugs
• Received >30 Gy chest radiation within 6 months prior to initial administration
• Palliative radiotherapy was completed within 7 days prior to initial administration
• Failure to recover from toxicity and/or complications of previous interventions to nCI-CTCAE ≤1
• The half-life of CYP3A4 suppressor, moderate inhibitor or strong inducer or moderate inducer is less than 3 or less than 14 days from the date of first drug use, and the shorter is selected
• Received systemic immunosuppressant therapy within 14 days prior to the first study
• Subjects with known or suspected interstitial pneumonia
• In the first study, failure to swallow, chronic diarrhea, gastroenteritis, intestinal obstruction, gastrointestinal perforation, postgastrectomy, or colitis, or other medical conditions or special conditions affecting drug administration and absorption occurred within 28 days prior to administration
• Presence of any active, known or suspected autoimmune disease
• Have poorly controlled or severe cardiovascular disease
• Previous or concurrent malignancy
• Subjects who developed a severe infection within 28 days prior to the first dose
• Active hepatitis B
• There were active tuberculosis patients within 1 year before enrollment
• There is a history of immunodeficiency
• Live attenuated vaccine was administered within 28 days prior to initial study administration or is expected to be administered during study treatment
• Subjects who are participating in another clinical study or who have had their first dose less than 4 weeks since the end of the previous clinical study (last dose) or 5 half-lives of the study drug, whichever is shorter
• Major surgery other than diagnosis or biopsy was performed within 28 days prior to initial administration
• People who are known to be allergic to sir-A1811, pyrrolitinib, or any of the components of SIR-1316
• History of severe allergic reactions to other monoclonal antibody/fusion protein drugs
• Female subjects who are pregnant, breast-feeding, or planning to become pregnant during the study
• Uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse and detention
• Any other conditions that, in the investigator's judgment, may increase the risk of study participation, interfere with study results, or make study participation unsuitable