Trial Title:
AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
NCT ID:
NCT05904379
Condition:
Advanced Non-small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Docetaxel
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK112
Description:
Subjects receive AK112 intravenously.
Arm group label:
AK112 plus AK104
Arm group label:
AK112, AK104 dose 1 plus carboplatin and paclitaxel
Arm group label:
AK112, AK104 dose 1 plus carboplatin and pemetrexed
Arm group label:
AK112, AK104 dose 2 plus carboplatin and paclitaxel
Arm group label:
AK112, AK104 dose 2 plus carboplatin and pemetrexed
Arm group label:
AK112, AK104 plus docetaxel
Intervention type:
Drug
Intervention name:
AK104
Description:
Subjects receive AK104 intravenously.
Arm group label:
AK112 plus AK104
Arm group label:
AK112, AK104 dose 1 plus carboplatin and paclitaxel
Arm group label:
AK112, AK104 dose 1 plus carboplatin and pemetrexed
Arm group label:
AK112, AK104 dose 2 plus carboplatin and paclitaxel
Arm group label:
AK112, AK104 dose 2 plus carboplatin and pemetrexed
Arm group label:
AK112, AK104 plus docetaxel
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Subjects receive carboplatin intravenously.
Arm group label:
AK112, AK104 dose 1 plus carboplatin and paclitaxel
Arm group label:
AK112, AK104 dose 1 plus carboplatin and pemetrexed
Arm group label:
AK112, AK104 dose 2 plus carboplatin and paclitaxel
Arm group label:
AK112, AK104 dose 2 plus carboplatin and pemetrexed
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
Subjects receive paclitaxel intravenously.
Arm group label:
AK112, AK104 dose 1 plus carboplatin and paclitaxel
Arm group label:
AK112, AK104 dose 2 plus carboplatin and paclitaxel
Intervention type:
Drug
Intervention name:
pemetrexed
Description:
Subjects receive pemetrexed intravenously.
Arm group label:
AK112, AK104 dose 1 plus carboplatin and pemetrexed
Arm group label:
AK112, AK104 dose 2 plus carboplatin and pemetrexed
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Subjects receive docetaxel intravenously.
Arm group label:
AK112, AK104 plus docetaxel
Arm group label:
docetaxel
Summary:
This trial is a Phase Ib/II study. All patients are stage IIIB/C (unsuitable for radical
therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group
(ECOG) performance status 0-1. The purpose of this study is to evaluate the safety and
efficacy of AK112 and AK104 with or without chemotherapy in subjects with advanced NSCLC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has a histologically or cytologically confirmed diagnosis of NSCLC.
- Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC 8th]).
- 18-75 years old (at the time consent is obtained).
- Be able and willing to provide written informed consent and to comply with all
requirements of study participation (including all study procedures).
- Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue.
- Has a life expectancy of at least 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 as determined by the site study team.
- Has no EGFR-sensitive mutations or ALK gene translocations.
- Has adequate organ function.
- Has recovered from the effects of any prior radiotherapy or surgery.
- All female and male subjects of reproductive potential must agree to use an
effective method of contraception, during and for 120 days after the last dose of
study treatment.
Exclusion Criteria:
- Has any histologically small cell carcinoma component.
- Is currently participating in a study of an investigational agent or using an
investigational device.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within
2 years prior to the first dose of study treatment.
- Has undergone major surgery within 30 days of Study Day 1.
- Has a known additional malignancy that is progressing or requires systemic
treatment. Exceptions include basal cell carcinoma of the skin, squamous cell
carcinoma of the skin that has undergone potentially curative therapy or in situ
cervical cancer.
- Has known active central nervous system (CNS) metastases.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years (i.e. with use of disease modifying agents, corticosteroids or
immunosuppressive drugs).
- Has an active infection requiring systemic therapy.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected).
- Has a history of myocardial infarction, unstable angina, congestive heart failure
within 12 months prior to day 1 of study treatment.
- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
subject's participation for the full duration of the study, or is not in the best
interest of this subject to participate, in the opinion of the treating
investigator.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.
- Has received a live virus vaccine within 30 days of the planned first dose of study
therapy.
- Has any concurrent medical condition that, in the opinion of the Investigator, would
complicate or compromise compliance with the study or the well-being of the subject.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yun Fan, MD
Phone:
+86-0571-88122222
Email:
fanyun@zjcc.org.cn
Investigator:
Last name:
Yun Fan, MD
Email:
Principal Investigator
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou, MD
Phone:
+86-021-65115006
Email:
caicunzhoudr@163.com
Investigator:
Last name:
Caicun Zhou, MD
Email:
Principal Investigator
Start date:
July 13, 2023
Completion date:
January 31, 2027
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/NCT05904379
