Clinical trial NCT05904379: AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
Official title: A Phase Ib/II Clinical Trial of AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Non-small-cell Lung Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Safety reflected by AE
timeFrame: Up to 2 approximately years
measure: ORR per RECIST v1.1
timeFrame: Up to 2 approximately years
Secondary outcomes:
measure: OS
timeFrame: Up to 2 approximately years
measure: DoR per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: DCR per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: TTR per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: PFS per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: AK112 serum concentration
timeFrame: Up to 2 approximately years
measure: AK104 serum concentration
timeFrame: Up to 2 approximately years
measure: ADA
timeFrame: Up to 2 approximately years
measure: PD-L1 expression
timeFrame: Up to 2 approximately years
measure: ctDNA
timeFrame: Up to 2 approximately years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
Study officials:
References: