Non-Small Cell Lung CancerPhase 3NSCLCNCT06928389
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
A Phase 3 study testing Ivonescimab, docetaxel in people with Non-Small Cell Lung Cancer, run by Akeso at 1 site in China.
Trial summary
This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Ivonescimab, docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 536 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2025to Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- Age ≥ 18 years old and ≤ 75 years old at the time of randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected life expectancy of at least 3 months.
- Histologically or cytologically confirmed diagnosis of NSCLC.
- Locally advanced or metastatic NSCLC (American Joint Committee on Cancer [AJCC] 8th edition).
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- Previously received systemic platinum-based chemotherapy and PD-1/L1 inhibitors.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Adequate organ function.
Who cannot join
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.
- Other malignancies within 3 years prior to randomization.
- Known actionable genomic alterations.
- Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
- Previous treatment with docetaxel.
- History of severe bleeding tendency or coagulation dysfunction.
- Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.
- History of myocarditis, cardiomyopathy, and malignant arrhythmia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Caicun Zhou
About this study
Official title: A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy
This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Ivonescimab, docetaxel, Placebo, docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab, docetaxelDrug
Also called AK112, docetaxel
Patients will receive ivonescimab and docetaxel as an IV injection
Placebo, docetaxelDrug
Patients will receive placebo and docetaxel as an IV injection
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab and docetaxel | Experimental | Not described Receives: Drug: Ivonescimab, docetaxel |
| Placebo and docetaxel | Active comparator | Not described Receives: Drug: Placebo, docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall Survival (OS) in the FAS population
Measured: approximately 5 years
Secondary outcomes (2)
Progression Free Survival (PFS)
Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1
Measured: approximately 3 years
Adverse Event (AE)
Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
Measured: From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start8 Jul 2025
- Primary completionMay 2027 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928389
- Sponsor's protocol ID
- AK112-305 (HARMONi-8A)
- Acronym
- NSCLC
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2025
- Last updated
- 9 Apr 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy
- ClinicalTrials.gov ID
- NCT06928389
- Acronym / sponsor ID
- NSCLC / AK112-305 (HARMONi-8A)
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 15 Apr 2025 (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.
This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab and docetaxel | Experimental | Drug: Ivonescimab, docetaxel |
| Placebo and docetaxel | Active comparator | Drug: Placebo, docetaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- Age ≥ 18 years old and ≤ 75 years old at the time of randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected life expectancy of at least 3 months.
- Histologically or cytologically confirmed diagnosis of NSCLC.
Key exclusion criteria (8 listed)
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.
- Other malignancies within 3 years prior to randomization.
- Known actionable genomic alterations.
- Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
- Previous treatment with docetaxel.
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 |
|---|---|---|
| Ivonescimab, docetaxelAlso: AK112, docetaxelPatients will receive ivonescimab and docetaxel as an IV injection | Drug | Ivonescimab and docetaxel |
| Placebo, docetaxelPatients will receive placebo and docetaxel as an IV injection | Drug | Placebo and docetaxel |
Primary outcome
Overall Survival (OS)
Time frame: approximately 5 years
Overall Survival (OS) in the FAS population
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: approximately 3 years
Adverse Event (AE)
Time frame: From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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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.
Caicun Zhou principal investigator
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivonescimab, docetaxel in people with 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenting Li (18116403289, wenting01.li@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: approximately 5 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 9 Apr 2026.