Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04736823
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Akeso

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a phase II study. All patients are stage IIIB/C 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 efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC.

Condition or disease Intervention/treatment Phase
NSCLC Drug: AK112 Drug: Pemetrexed Drug: Paclitaxel Drug: Carboplatin Drug: Docetaxel Drug: AK105 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Part1 Cohort1(AK112 + Pemetrexed or Paclitaxel+Carboplatin)

non-Squamous NSCLC:Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.

Squamous NSCLC:Subjects receive AK112 plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 until progression.

 Drug: AK112
IV infusion

Drug: Pemetrexed
IV infusion

Drug: Paclitaxel
IV infusion

Drug: Carboplatin
IV infusion
Experimental: Part1 Cohort2(AK112 + Pemetrexed +Carboplatin)
Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.
 Drug: AK112
IV infusion

Drug: Pemetrexed
IV infusion

Drug: Carboplatin
IV infusion
Experimental: Part1 Cohort3(AK112 + Docetaxel)
Subjects receive AK112 plus Docetaxel on Day 1 of every 3-week cycle (Q3W) until progression.
 Drug: AK112
IV infusion

Drug: Docetaxel
IV infusion
Experimental: Part2 Cohort1(AK112 + Pemetrexed or Paclitaxel+Carboplatin)

non-Squamous NSCLC:Subjects receive AK112 plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression.

Squamous NSCLC:Subjects receive AK112 plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 until progression.

 Drug: AK112
IV infusion

Drug: Pemetrexed
IV infusion

Drug: Paclitaxel
IV infusion

Drug: Carboplatin
IV infusion
Experimental: Part2 Cohort2(Penpulimab(AK105) + Pemetrexed or Paclitaxel+Carboplatin)

non-Squamous NSCLC:Subjects receive Penpulimab(AK105) plus Pemetrexed and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by Penpulimab(AK105) plus Pemetrexed until progression.

Squamous NSCLC:Subjects receive Penpulimab(AK105) plus Paclitaxel and Carboplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by Penpulimab(AK105) until progression.

 Drug: AK112
IV infusion

Drug: Pemetrexed
IV infusion

Drug: Paclitaxel
IV infusion

Drug: AK105
IV infusion


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. ORR (Part 1) [ Time Frame: Up to approximately 2 years ]
    ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.

  2. PFS (Part 2) [ Time Frame: Up to approximately 2 years ]
    PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).


Secondary Outcome Measures :
  1. PFS (Part 1) [ Time Frame: Up to approximately 2 years ]
    PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).

  2. ORR (Part 2) [ Time Frame: Up to approximately 2 years ]
    ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.

  3. OS [ Time Frame: Up to approximately 2 years ]
    OS is the time from the date of randomization or first dosing date to death due to any cause.

  4. Disease control rate (DCR) [ Time Frame: Up to approximately 2 years ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 75 years old (at the time of inform consent 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 Stage IIIB/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 assessed by investigator
  • Has adequate organ function
  • 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 prior to the first dose of study treatment;
  • Has a known history of prior malignancy except that 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 prior to first dose of study treatment
  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736823


Contacts
Layout table for location contacts
Contact: Weifeng Song, MD +86(0760)89873999 clinicaltrials@akesobio.com

Locations
Layout table for location information
China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guanzhou, Guangdong, China
Contact: Li Zhang, MD    020-87343009    zhangli@sysucc.org.cn   
Principal Investigator: Li Zhang, MD         
Sponsors and Collaborators
Akeso
Investigators
Layout table for investigator information
Study Chair: Li Zhang, MD Sun Yat-sen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Akeso
ClinicalTrials.gov Identifier: NCT04736823    
Other Study ID Numbers: AK112-201
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Docetaxel
 Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors