Advanced Non-small Cell Lung CancerPhase 2NCT05215067
A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing AK104 and Docetaxel in people with Advanced Non-small Cell Lung Cancer, run by Akeso at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- AK104 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2022to 30 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- AK104, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
IV infusion,Specified dose on specified days
DocetaxelDrug
IV infusion,Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| AK104 plus Docetaxel | Experimental | AK104 RP2D + Docetaxel 75mg/m^2 every 3 weeks until progressive disease or unacceptable toxicity. Receives: Drug: AK104; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Up to approximately 2 years
Secondary outcomes (8)
Number of patients with Adverse Events (AEs)
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Measured: Up to approximately 2 years
Disease control rate (DCR)
Measured: Up to approximately 2 years
Duration of Response (DOR)
Measured: Up to approximately 2 years
Time to response (TTR)
Measured: Up to approximately 2 years
Progression free survival (PFS)
Measured: Up to approximately 2 years
Overall survival (OS)
Measured: Up to approximately 2 years
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104
Measured: Up to approximately 2 years
Antidrug antibodies (ADA) of AK104
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start13 May 2022
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215067
- Sponsor's protocol ID
- AK104-215
- Status last verified
- Jun 2026
- First submitted
- 18 Jan 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05215067
- Acronym / sponsor ID
- AK104-215
- Conditions
- Advanced Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK104 plus Docetaxel | Experimental | Drug: AK104, Drug: DocetaxelAK104 RP2D + Docetaxel 75mg/m^2 every 3 weeks until progressive disease or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104IV infusion,Specified dose on specified days | Drug | AK104 plus Docetaxel |
| DocetaxelIV infusion,Specified dose on specified days | Drug | AK104 plus Docetaxel |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
8 secondary outcomes
Number of patients with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104
Time frame: Up to approximately 2 years
Antidrug antibodies (ADA) of AK104
Time frame: Up to approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
Related trials for Advanced Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104 and Docetaxel in people with Advanced Non-small Cell Lung Cancer, run by Akeso at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.