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

NCT05215067 | Active Not Recruiting Phase 2

• 1 other identifier: AK104-215
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Up to approximately 2 years

Secondary Outcomes (8)

• Number of patients with Adverse Events (AEs)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of Response (DOR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

• Progression free survival (PFS)

  Up to approximately 2 years

Study Arms (1)

AK104 plus Docetaxel

EXPERIMENTAL

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

Drug: AK104; Drug: Docetaxel

Interventions

AK104 DRUG

IV infusion,Specified dose on specified days

AK104 plus Docetaxel

Docetaxel DRUG

IV infusion,Specified dose on specified days

AK104 plus Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old.
• Have a life expectancy of at least 3 months.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.
• Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered.
• No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
• Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator.
• Has adequate organ function.

You may not qualify if:

• Undergone major surgery within 30 days prior to the first dose of study treatment.
• Active central nervous system (CNS) metastases.
• History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
• Active Hepatitis B or Hepatitis C.
• Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
• Has received treatment with docetaxel.
• History of severe bleeding tendency or coagulation disorder.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: March 9, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CN (1)