Back to resultsAK104 Monotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK104
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring neoadjuvant and adjuvant therapy, bispecific antibody
Eligibility Criteria
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
- Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
- Have adequate organ function.
Key Exclusion Criteria:
- Mixed NSCLC and small cell lung cancer histology.
- Patients with other active malignancies within 3 years prior to enrollment.
- Known active autoimmune diseases.
- Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
- Presence of other uncontrolled serious medical conditions.
Sites / Locations
- Henan Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AK104
Arm Description
Participants receive two cycles of AK104 as neoadjuvant therapy prior to surgery; followed by surgery; followed by standard adjuvant chemotherapy +/- radiotherapy per investigator; followed by adjuvant AK104 for 6 months.
Outcomes
Primary Outcome Measures
Major Pathological Response (MPR) Rate
defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Secondary Outcome Measures
Pathological Complete Response (pCR) Rate
defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Incidence of Surgical Complications
defined as ≥ grade 3 or severe intraoperative and perioperative complications.
Complete (R0) Resection Rate
defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.
Objective Response Rate (ORR)
defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Event Free Survival (EFS)
defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
Adverse Events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05377658
Brief Title
AK104 Monotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Official Title
An Open-label, Single-center, Phase II Study of AK104 Monotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2022 (Anticipated)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
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
AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 monotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
neoadjuvant and adjuvant therapy, bispecific antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AK104
Arm Type
Experimental
Arm Description
Participants receive two cycles of AK104 as neoadjuvant therapy prior to surgery; followed by surgery; followed by standard adjuvant chemotherapy +/- radiotherapy per investigator; followed by adjuvant AK104 for 6 months.
Intervention Type
Drug
Intervention Name(s)
AK104
Other Intervention Name(s)
Cadonilimab
Intervention Description
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Major Pathological Response (MPR) Rate
Description
defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Time Frame
After surgery (approximately 7 weeks)
Secondary Outcome Measure Information:
Title
Pathological Complete Response (pCR) Rate
Description
defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Time Frame
After surgery (approximately 7 weeks)
Title
Incidence of Surgical Complications
Description
defined as ≥ grade 3 or severe intraoperative and perioperative complications.
Time Frame
Up to approximately 30 days following surgery
Title
Complete (R0) Resection Rate
Description
defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.
Time Frame
After surgery (approximately 7 weeks)
Title
Objective Response Rate (ORR)
Description
defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Time Frame
At the end of 2 cycles of neoadjuvant therapy (each cycle is 21 days)
Title
Event Free Survival (EFS)
Description
defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 5 years
Title
Adverse Events (AEs)
Time Frame
From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
Have adequate organ function.
Key Exclusion Criteria:
Mixed NSCLC and small cell lung cancer histology.
Patients with other active malignancies within 3 years prior to enrollment.
Known active autoimmune diseases.
Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
Presence of other uncontrolled serious medical conditions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huijuan Wang, MD
Phone
18638561588
Email
18638561588@163.com
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijuan Wang, MD
Phone
18638561588
Email
18638561588@163.com
12. IPD Sharing Statement
Learn more about this trial
AK104 Monotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
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