Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC

Launched by HENAN CANCER HOSPITAL · Jun 13, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to test two new treatments, SHR-A1921 and SHR-A2009, in patients with advanced non-small cell lung cancer (NSCLC) who have not responded to standard therapies. The goal is to see how safe and effective these treatments are for people whose cancer has continued to progress. The study is currently not recruiting participants, but it aims to include adults aged 18 to 75 who have confirmed advanced NSCLC and have had their cancer worsen after receiving previous treatments.

To participate, individuals must be in relatively good health with a life expectancy of at least 12 weeks. They should have measurable signs of cancer and agree to use contraception during the study. However, certain conditions, such as untreated brain metastases or a history of severe reactions to similar drugs, may prevent someone from joining. If you are eligible and choose to participate, you can expect to receive one of the study treatments and will be closely monitored for any side effects and how well the treatment works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary participation and written informed consent;
• • 2. Aged 18-75 years (inclusive), males and females;
• • 3. Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
• • 4. Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
• • 5. Has at least 1 measurable lesion per RECIST 1.1;
• • 6. Patients with ECOG score of 0-1;
• • 7. Life expectancy ≥12 weeks;
• • 8. Have adequate organ function;
• • 9. Participants agrees to use contraception, and be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of study treatment.
• Exclusion Criteria:
• • 1. Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
• • 2. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
• • 3. Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
• • 4. Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
• • 5. Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
• • 6. Has a history of a second malignancy;
• • 7. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
• • 8. Subjects with active pulmonary tuberculosis infection；
• • 9. Serious infection before the first dose；
• • 10. Uncontrolled cardiac diseases or symptoms;
• • 11. Arterial/venous thrombosis events occurred before the first dose；
• • 12. Hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy；
• • 13. Has a history of active chronic enteritis;
• • 14. Has a history of bleeding prior to the initiation of the study treatment;
• • 15. History of immunodeficiency disease or organ transplant;
• • 16. Subjects with active hepatitis B or active hepatitis C;
• • 17. Has unresolved toxicities from previous anticancer therapy;
• • 18. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921or SHR-A2009;
• • 19. Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.