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A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer

Sponsor
Akeso (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05215067
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
24.4
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of AK104 in Combination With Docetaxel in Subjects With Advanced Non-Small Cell Lung Cancer and Progressive Disease After Platinum Doublet Chemotherapy and Treatment With One Prior Anti-PD-1/PD-L1 Monoclonal Antibody (mAb)
Actual Study Start Date :
Mar 9, 2022
Anticipated Primary Completion Date :
Mar 20, 2023
Anticipated Study Completion Date :
Mar 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: AK104 plus Docetaxel

AK104 RP2D + Docetaxel 75mg/m^2 every 3 weeks until progressive disease or unacceptable toxicity.

Drug: AK104
IV infusion,Specified dose on specified days

Drug: Docetaxel
IV infusion,Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate (ORR) [Up to approximately 2 years]

Secondary Outcome Measures

  1. Number of patients with Adverse Events (AEs) [Up to approximately 2 years]

    Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs

  2. Disease control rate (DCR) [Up to approximately 2 years]

  3. Duration of Response (DOR) [Up to approximately 2 years]

  4. Time to response (TTR) [Up to approximately 2 years]

  5. Progression free survival (PFS) [Up to approximately 2 years]

  6. Overall survival (OS) [Up to approximately 2 years]

  7. Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104 [Up to approximately 2 years]

  8. Antidrug antibodies (ADA) of AK104 [Up to approximately 2 years]

Eligibility Criteria

Criteria

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

  1. 18 to 75 years old.

  2. Have a life expectancy of at least 3 months.

  3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  4. Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.

  5. Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered.

  6. No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.

  7. Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator.

  8. Has adequate organ function.

Exclusion Criteria:

  1. Undergone major surgery within 30 days prior to the first dose of study treatment.

  2. Active central nervous system (CNS) metastases.

  3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).

  4. Active Hepatitis B or Hepatitis C.

  5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.

  6. Has received treatment with docetaxel.

  7. History of severe bleeding tendency or coagulation disorder.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Cancer Hospital Nanjing Jiangsu China 210009

Sponsors and Collaborators

  • Akeso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akeso
ClinicalTrials.gov Identifier:
NCT05215067
Other Study ID Numbers:
  • AK104-215
First Posted:
Jan 31, 2022
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel

Study Results

No Results Posted as of Apr 1, 2022