NCT05215067CompletedPhase 2
A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer
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)
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 18 Jan 2022
- Start date
- 13 May 2022
- Primary completion date
- 30 Jan 2026
- Lead sponsor
- Akeso
- Diseases
- Lung cancer
- NCT number
- NCT05215067
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 44
- From 13 May 2022 to the primary completion date, 30 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Undergone major surgery within 30 days prior to the first dose of study treatment.
- 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.
Other illness
- 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.
- History of severe bleeding tendency or coagulation disorder.
Other
- Active central nervous system (CNS) metastases.
Who the study is looking for
- 18 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.