Back to resultsAK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC
Primary Purpose
Resectable Non-small Cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AK112
Carboplatin
Cisplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Resectable Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
1、18 to 75 years old
2、Be able and willing to provide written informed consent and to comply with all requirements of study participation
3、Histologically confirmed resectable stage II-IIIB NSCLC
4、Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5、Has adequate organ function
6、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 an active autoimmune disease that has required systemic treatment in the past 2 years
- 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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
arm 1(AK112)
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
Arm Description
Neoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
Neoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events (AE)
Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0
rate of surgical delays
Proportion of subjects exceeding the maximum surgical time window
abnormal laboratory findings of clinical significance
Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests, thyroid function tests, routine urine tests, pregnancy tests, etc.
MPR
Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor foci and lymph nodes
Secondary Outcome Measures
R0 resection rate
Proportion of subjects with pathologically complete resection of primary tumors
Tumor descending stage rate
Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline
pCR
Proportion of subjects with no residual tumor in the resected tumor primary and lymph nodes
OS
Time from first dose until death from any cause
EFS
Time from first dose to the occurrence of any of the following events, whichever occurs first: disease progression, local recurrence or distant metastasis or death from any cause, as assessed according to RECIST v1.1.
ORR
ORR is the proportion of subjects with CR or PR,based on recist v1.1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05247684
Brief Title
AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC
Official Title
Phase II Clinical Study of AK112, an Anti-PD-1 and VEGF Bispecific Antibody, Alone or in Combination With Chemotherapy for the Neoadjuvant/Adjuvant Treatment of Resectable Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 20, 2022 (Anticipated)
Primary Completion Date
August 20, 2023 (Anticipated)
Study Completion Date
January 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC
Detailed Description
Phase II clinical study of AK112, an anti-PD-1 and VEGF bispecific antibody, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
arm 1(AK112)
Arm Type
Experimental
Arm Description
Neoadjuvant therapy was 3-4 cycles of AK112(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
Arm Title
arm 2(AK112+Carboplatin/cisplatin + paclitaxel)
Arm Type
Experimental
Arm Description
Neoadjuvant therapy was 3-4 cycles of AK112 plus Carboplatin/cisplatin + paclitaxel(Q3W), followed by surgery ,followed by adjuvant therapy for 16 cycles of AK112(Q3W)
Intervention Type
Drug
Intervention Name(s)
AK112
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events (AE)
Description
Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0
Time Frame
Up to approximately 2 years
Title
rate of surgical delays
Description
Proportion of subjects exceeding the maximum surgical time window
Time Frame
Up to approximately 2 years
Title
abnormal laboratory findings of clinical significance
Description
Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests, thyroid function tests, routine urine tests, pregnancy tests, etc.
Time Frame
Up to approximately 2 years
Title
MPR
Description
Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor foci and lymph nodes
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
R0 resection rate
Description
Proportion of subjects with pathologically complete resection of primary tumors
Time Frame
Up to approximately 2 years
Title
Tumor descending stage rate
Description
Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline
Time Frame
Up to approximately 2 years
Title
pCR
Description
Proportion of subjects with no residual tumor in the resected tumor primary and lymph nodes
Time Frame
Up to approximately 2 years
Title
OS
Description
Time from first dose until death from any cause
Time Frame
Up to approximately 2 years
Title
EFS
Description
Time from first dose to the occurrence of any of the following events, whichever occurs first: disease progression, local recurrence or distant metastasis or death from any cause, as assessed according to RECIST v1.1.
Time Frame
Up to approximately 2 years
Title
ORR
Description
ORR is the proportion of subjects with CR or PR,based on recist v1.1
Time Frame
Up to approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1、18 to 75 years old
2、Be able and willing to provide written informed consent and to comply with all requirements of study participation
3、Histologically confirmed resectable stage II-IIIB NSCLC
4、Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5、Has adequate organ function
6、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 an active autoimmune disease that has required systemic treatment in the past 2 years
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Song, MD
Phone
86(0760)89873999
Email
clinicaltrials@akesobio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Changli Wang
12. IPD Sharing Statement
Learn more about this trial
AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC
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