AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
NCT ID: NCT05904379
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
233 participants
INTERVENTIONAL
2023-07-13
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AK112, AK104 dose 1 plus carboplatin and paclitaxel
AK112
Subjects receive AK112 intravenously.
AK104
Subjects receive AK104 intravenously.
Carboplatin
Subjects receive carboplatin intravenously.
paclitaxel
Subjects receive paclitaxel intravenously.
AK112, AK104 dose 1 plus carboplatin and pemetrexed
AK112
Subjects receive AK112 intravenously.
AK104
Subjects receive AK104 intravenously.
Carboplatin
Subjects receive carboplatin intravenously.
pemetrexed
Subjects receive pemetrexed intravenously.
AK112, AK104 dose 2 plus carboplatin and paclitaxel
AK112
Subjects receive AK112 intravenously.
AK104
Subjects receive AK104 intravenously.
Carboplatin
Subjects receive carboplatin intravenously.
paclitaxel
Subjects receive paclitaxel intravenously.
AK112, AK104 dose 2 plus carboplatin and pemetrexed
AK112
Subjects receive AK112 intravenously.
AK104
Subjects receive AK104 intravenously.
Carboplatin
Subjects receive carboplatin intravenously.
pemetrexed
Subjects receive pemetrexed intravenously.
AK112 plus AK104
AK112
Subjects receive AK112 intravenously.
AK104
Subjects receive AK104 intravenously.
AK112, AK104 plus docetaxel
AK112
Subjects receive AK112 intravenously.
AK104
Subjects receive AK104 intravenously.
Docetaxel
Subjects receive docetaxel intravenously.
docetaxel
Docetaxel
Subjects receive docetaxel intravenously.
Interventions
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AK112
Subjects receive AK112 intravenously.
AK104
Subjects receive AK104 intravenously.
Carboplatin
Subjects receive carboplatin intravenously.
paclitaxel
Subjects receive paclitaxel intravenously.
pemetrexed
Subjects receive pemetrexed intravenously.
Docetaxel
Subjects receive docetaxel intravenously.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Shanghai Pulmonary Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AK112-208
Identifier Type: -
Identifier Source: org_study_id
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