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Trial Title:
Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients
NCT ID:
NCT05636267
Condition:
NSCLC
Conditions: Official terms:
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK119
Description:
AK119 IV every 3 weeks.
Arm group label:
AK119 + AK112
Arm group label:
AK119 + AK112 + Pemetrexed + Carboplatin
Intervention type:
Drug
Intervention name:
AK112
Description:
AK112 IV every 3 weeks.
Arm group label:
AK112
Arm group label:
AK119 + AK112
Arm group label:
AK119 + AK112 + Pemetrexed + Carboplatin
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed IV every 3 weeks.
Arm group label:
AK119 + AK112 + Pemetrexed + Carboplatin
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin IV every 3 weeks.
Arm group label:
AK119 + AK112 + Pemetrexed + Carboplatin
Summary:
This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and
anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yilong Wu, PhD
Start date:
February 10, 2023
Completion date:
March 2025
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05636267
