- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04544644
A Study of Combination Therapy in NSCLC
September 3, 2020 updated by: Weiwei Shi, Chinese PLA General Hospital
A Phase II Study of AK104 (Binding Kenetics to PD-1 and CTLA-4) in Combination With Anlotinib in Patients With Advanced NSCLC
This trial is a single arm, two cohorts, phase II study.
All patients are stage IIIB-IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene.
Cohort 1 includes patients with metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially.
Cohort 2 includes treatment naïve patients with advanced NSCLC.
All patients will recieve AK104 15mg/kg every 3 weeks(for up to 2 years) and anlotinib(12mg/d).
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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: weiwei Shi
- Phone Number: +86 01066875308
- Email: shiweiwei301@sina.com
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:
- Aged 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;
- Additional Inclusion Criteria for Cohort 1: Has metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially;
- Additional Exclusion Criteria for Cohort 2: Have no prior systemic chemotherapy for metastatic disease: at least 6 months since prior adjuvant chemotherapy;
- EGFR/ALK negative;
- 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: (1) Absolute neutrophil count >= 1,500/uL; (2) Platelets >= 100,000/uL; (3) Hemoglobin >= 9 g/dL; (4) Crcl >= 50ml/min; creatinine clearance may be calculated using the institutional/laboratory standard method; (5) Serum total bilirubin <= 1.5 ULN; (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 ULN; (7) Albumin >= 28g/L; (8) International Normalized Ratio (INR) and aPTT <1.5 ULN; (9) 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment arm
AK104+anlotinib
|
AK 104 is given by intravenous infusion and anlotinib is given by oral.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
---|---|---|
PFS and OS
Time Frame: through study completion, an average of 2 years
|
progression-free survival and overall survival
|
through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: weiwei Shi, Chinese PLA General Hospital
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 (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
August 29, 2020
First Submitted That Met QC Criteria
September 3, 2020
First Posted (Actual)
September 10, 2020
Study Record Updates
Last Update Posted (Actual)
September 10, 2020
Last Update Submitted That Met QC Criteria
September 3, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT-001
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.
Clinical Trials on Non-small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
Clinical Trials on AK104+anlotinib
-
Hunan Cancer HospitalNot yet recruiting
-
Zhongnan HospitalAkeso Biopharma Co., Ltd.Recruiting
-
AkesoNot yet recruiting
-
Second Affiliated Hospital of Zunyi Medical UniversityGuizhou Provincial People's Hospital; The First People's Hospital of Zunyi; Guizhou... and other collaboratorsRecruitingImmunotherapy | Second-line TreatmentChina
-
Wuhan Union Hospital, ChinaRecruiting
-
AkesoNot yet recruitingHepatocellular CarcinomaChina
-
AkesoActive, not recruitingAdvanced or Metastatic Solid TumorsAustralia
-
Peking Union Medical College HospitalRecruitingPheochromocytoma | ParagangliomaChina