Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients

Launched by AKESO · Nov 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two new treatments called AK119 and AK112, either alone or combined with chemotherapy, for patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The goal is to see how safe these treatments are, how well they work, and how they are processed in the body. Currently, the trial is recruiting participants aged 18 to 75 who have advanced NSCLC with a certain genetic mutation and have not responded to previous treatments.

To join the study, patients must be willing to sign consent forms and have a life expectancy of at least three months. They should have measurable cancer lesions and good overall health, meaning their organs are functioning well. However, individuals with other types of lung cancer, serious infections, or certain past medical conditions may not qualify. Participants in the trial will receive careful monitoring and support throughout the study, and they may contribute to important research that could lead to better treatments for lung cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be able to understand and voluntarily sign the written informed consent, which must be signed before the designated research procedure.
• • 2. Age ≥ 18 and ≤ 75, male or female.
• • 3. Local advanced or metastatic non-squamous NSCLC confirmed by histology or cytology according to eighth edition of the TNM classification for lung cancer.
• • 4. EGFR activating mutation confirmed by tumor histology, cytology or hematology.
• • 5. Failed to previous EGFR-TKI treatment.
• • 6. ECOG performance status 0 to1.
• • 7. Life expectancy ≥3 months.
• • 8. At least one measurable lesion according to RECIST v1.1.
• • 9. Adequate organ function.
• Exclusion Criteria:
• • 1. Histological or cytological pathology confirmed the presence of small cell carcinoma or squamous cell carcinoma.
• • 2. Have suffered from the second primary active malignant tumor in the past 3 years.
• • 3. There are other driving gene mutations that can obtain effective treatment.
• • 4. Receipt of the following treatments or procedures: immunotherapy, including immunocheckpoint inhibitors, immunocheckpoint agonists, immunocellular therapy, and any other treatment targeting tumor immune mechanism; systematic chemotherapy in the advanced stage (IIIB-IV); anti-angiogenesis drugs, except for small molecule anti-angiogenesis drugs with drug withdrawal more than 4 weeks; extensive radiotherapy within 4 weeks; EGFR-TKIs within 2 weeks.
• • 5. Symptomatic central nervous system metastases.
• • 6. The toxicity of previous anti-tumor therapy has not been alleviated.
• • 7. Uncontrolled massive ascites, pleural effusion or pericardial effusion.
• • 8. Active autoimmune diseases in the past 2 years.
• • 9. History of interstitial lung disease or noninfectious pneumonitis.
• • 10. Suffering from clinically significant cardiovascular or cerebrovascular diseases.
• • 11. History of severe bleeding tendency or coagulation dysfunction.
• • 12. History of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism in the past 3 months.
• • 13. Serious infection in the past 4 weeks.
• • 14. Acute exacerbation of chronic obstructive pulmonary disease or asthma in the past 4 weeks.
• • 15. History of human immunodeficiency virus (HIV) infection.
• • 16. History of severe hypersensitivity reactions to other mAbs.
• • 17. History of organ transplantation.
• • 18. Any other conditions that, in the opinion of the investigator, may increase the risk when receiving the investigational product.

Trial Officials