- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646330
A Trial of AK104 Plus Anlotinib in NSCLC
May 18, 2022 updated by: Akeso
A Phase Ib/II Trial of AK104 Plus Anlotinib in Patients With NSCLC
This trial is a single arm, two cohorts, phase Ib/II study.
All patients are stage IIIB/C or IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Cohort 1 includes treatment naïve patients with advanced NSCLC.
Cohort 2 includes patients with metastatic or recurrent NSCLC after progression on treatment with PD-1/PD-L1.
The primary end point are objective response rate per RECIST1.1 and safety.
Secondary end points are progression-free survival and overall survival.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China
- Hunan Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 to 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).
- Have histologically- or cytologically-confirmed diagnosis of StageIIIB/C or IV NSCLC.
- Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy.
- Have a life expectancy of at least 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team
- Has adequate organ function as defined by:Absolute neutrophil count ≥ 1,500/µL;Platelets ≥ 100,000/µL;Hemoglobin ≥ 9 g/dL;Crcl ≥ 50ml/min creatinine clearance may be calculated using the institutional/laboratory standard method.Serum total bilirubin ≤ 1.5 x ULN ;Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN ;Albumin ≥28g/L;International Normalized Ratio (INR) and aPTT <1.5 x ULN. Left ventricular ejection fraction ≥50%.
- Have 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, as determined by the Investigator, 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 carcinomatous meningitis
- 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). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study;
- 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);
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery 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
- Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AK104 10mg/kg Q2W plus anlotinib
Subjects receive AK104 10mg/kg every 2-week cycle(Q2W) intravenously (IV) plus anlotinib 1-14days of every 3-week cycle (Q3W) until no more benefits from treatment.
|
Subjects receive AK104 10mg/kg intravenously (IV) every 2-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.
Subjects receive AK104 15mg/kg intravenously (IV) every 3-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.
Subjects receive AK104 10mg/kg Q3W plus anlotinib 1-14days of every 3-week cycle until progression.
|
EXPERIMENTAL: AK104 15mg/kg Q3W plus anlotinib
Subjects receive AK104 15mg/kg intravenously (IV) plus anlotinib 1-14days of every 3-week cycle (Q3W) until no more benefits from treatment.
|
Subjects receive AK104 10mg/kg intravenously (IV) every 2-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.
Subjects receive AK104 15mg/kg intravenously (IV) every 3-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.
Subjects receive AK104 10mg/kg Q3W plus anlotinib 1-14days of every 3-week cycle until progression.
|
EXPERIMENTAL: AK104 10mg/kg Q3W plus anlotinib
Subjects receive AK104 10mg/kg Q3W plus anlotinib 1-14days of every 3-week cycle until no more benefits from treatment.
|
Subjects receive AK104 10mg/kg intravenously (IV) every 2-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.
Subjects receive AK104 15mg/kg intravenously (IV) every 3-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.
Subjects receive AK104 10mg/kg Q3W plus anlotinib 1-14days of every 3-week cycle until progression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: through study completion, an average of 1 year
|
objective response rate per RECIST1.1
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: Up to 2 years
|
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
|
Up to 2 years
|
progession-free survival (PFS)
Time Frame: through study completion, an average of 1 year
|
progession-free survival per RECIST1.1
|
through study completion, an average of 1 year
|
overall survival (OS)
Time Frame: through study completion, an average of 1 year
|
overall survival per RECIST1.1
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 18, 2020
Primary Completion (ANTICIPATED)
November 1, 2022
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
November 23, 2020
First Submitted That Met QC Criteria
November 23, 2020
First Posted (ACTUAL)
November 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK104-208
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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