Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK104 plus Docetaxel
- description
- AK104 RP2D + Docetaxel 75mg/m\^2 every 3 weeks until progressive disease or unacceptable toxicity.
- interventionNames
- Drug: AK104
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to approximately 2 years
Secondary outcomes (8)
- measure
- Number of patients with Adverse Events (AEs)
- timeFrame
- Up to approximately 2 years
- description
- Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available