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AK104 Monotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05377658
Collaborator
(none)
32
Enrollment
1
Location
1
Arm
66
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 30, 2022
Anticipated Primary Completion Date :
Feb 29, 2024
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: AK104

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.

Drug: AK104
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Other Names:
  • Cadonilimab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Major Pathological Response (MPR) Rate [After surgery (approximately 7 weeks)]

      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

    1. Pathological Complete Response (pCR) Rate [After surgery (approximately 7 weeks)]

      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.

    2. Incidence of Surgical Complications [Up to approximately 30 days following surgery]

      defined as ≥ grade 3 or severe intraoperative and perioperative complications.

    3. Complete (R0) Resection Rate [After surgery (approximately 7 weeks)]

      defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.

    4. Objective Response Rate (ORR) [At the end of 2 cycles of neoadjuvant therapy (each cycle is 21 days)]

      defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

    5. Event Free Survival (EFS) [Up to approximately 5 years]

      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.

    6. Adverse Events (AEs) [From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

    2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.

    3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator.

    4. Have adequate organ function.

    Key Exclusion Criteria:

    1. Mixed NSCLC and small cell lung cancer histology.

    2. Patients with other active malignancies within 3 years prior to enrollment.

    3. Known active autoimmune diseases.

    4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.

    5. Presence of other uncontrolled serious medical conditions.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henan Cancer Hospital Zhengzhou Henan China 450003

    Sponsors and Collaborators

    • Henan Cancer Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Huijuan Wang, chief physician, Henan Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05377658
    Other Study ID Numbers:
    • AK104-IIT-005
    First Posted:
    May 17, 2022
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Huijuan Wang, chief physician, Henan Cancer Hospital
    neoadjuvant and adjuvant therapy
    bispecific antibody
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of May 17, 2022