Non-Small Cell Lung CancerPhase 1/2NCT07623356
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing AK138D1, Ivonescimab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Akeso at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. 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?
- AK138D1, Ivonescimab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2026to 3 Jul 2030
- Phase
- Phase 1/2
- 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
- The subject must sign the written informed consent form (ICF) voluntarily;
- At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Has a life expectancy of ≥ 3 months;
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Has Stage IIIB/IIIC or IV non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer [AJCC]).
- Adequate organ function.
Who cannot join
- Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
- Presence of active central nervous system (CNS) metastases.
- Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
- Untreated subjects with active hepatitis B or active hepatitis C;
- Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
- Known active syphilis infection;
- Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
- Other reasons for ineligibility as evaluated by investigator.
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, +8613301825532, caicunzhoudr@163.com
About this study
Official title: A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Non-Small Cell Lung Cancer
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer.
Participants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.
Read the detailed description
This is a multicenter, open-label phase Ib/II study of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. The phase Ib portion is designed to evaluate the safety, tolerability, and preliminary antitumor activity of AK138D1 in combination with ivonescimab. The phase II portion is designed to evaluate the safety and efficacy of AK138D1 as monotherapy or in combination with ivonescimab.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- AK138D1, Ivonescimab, Carboplatin
- Keywords
- Non-Small Cell Lung Cancer
- 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.
AK138D1Drug
Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
IvonescimabDrug
Enrolled subjects will receive intravenous infusion (IV) of Ivonescimab according to the dosing regimen specified in their cohort.
CarboplatinDrug
Enrolled subjects will receive intravenous infusion (IV) of Carboplatin according to the dosing regimen specified in their cohort.
| Study group | Role | What they receive |
|---|---|---|
| AK138D1 | Experimental | AK138D1 will be administered at pre-specified dose levels. Receives: Drug: AK138D1 |
| AK138D1+ Ivonescimab | Experimental | AK138D1 and ivonescimab will be administered at pre-specified dose levels. Receives: Drug: AK138D1; Drug: Ivonescimab |
| AK138D1 + Ivonescimab + Carboplatin | Experimental | AK138D1, ivonescimab and carboplatin will be administered at pre-specified dose levels. Receives: Drug: AK138D1; Drug: Ivonescimab; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence and severity of subjects with adverse events
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR) , assessed by investigator according to RECIST v1.1.
Measured: Up to approximately 2 years
Secondary outcomes (7)
Disease Control Rate (DCR)
Disease control rate (DCR) assessed by investigator according to RECIST v1.1.
Measured: Up to approximately 2 years
Duration of response (DoR)
Duration of response (DoR) assessed by investigator according to RECIST v1.1.
Measured: Up to approximately 2 years
Time to response (TTR)
Time to response (TTR) is defined as the time to response assessed by investigator according to RECIST v1.1.
Measured: Up to approximately 2 years
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from randomization to the first documented disease progression (per RECIST v1.1) assessed by investigator or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 2 years
Pharmacokinetics (PK) characteristics
Serum drug concentration profiles at different time points after administration.
Measured: Up to approximately 2 years
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
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 posted3 Jun 2026
- Study start7 Jul 2026
- Primary completion18 Jun 2028 (estimated)
- Study completion3 Jul 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623356
- Sponsor's protocol ID
- AK138D1-201
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07623356
- Acronym / sponsor ID
- AK138D1-201
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 3 Jul 2030 (estimated)
- First posted
- 3 Jun 2026 (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.
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer.
Participants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.
Detailed description
This is a multicenter, open-label phase Ib/II study of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. The phase Ib portion is designed to evaluate the safety, tolerability, and preliminary antitumor activity of AK138D1 in combination with ivonescimab. The phase II portion is designed to evaluate the safety and efficacy of AK138D1 as monotherapy or in combination with ivonescimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AK138D1 | Experimental | Drug: AK138D1AK138D1 will be administered at pre-specified dose levels. |
| AK138D1+ Ivonescimab | Experimental | Drug: AK138D1, Drug: IvonescimabAK138D1 and ivonescimab will be administered at pre-specified dose levels. |
| AK138D1 + Ivonescimab + Carboplatin | Experimental | Drug: AK138D1, Drug: Ivonescimab, Drug: CarboplatinAK138D1, ivonescimab and carboplatin will be administered at pre-specified dose levels. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject must sign the written informed consent form (ICF) voluntarily;
- At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Has a life expectancy of ≥ 3 months;
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Key exclusion criteria (8 listed)
- Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
- Presence of active central nervous system (CNS) metastases.
- Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
- Untreated subjects with active hepatitis B or active hepatitis C;
- Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
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 |
|---|---|---|
| AK138D1Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort. | Drug | AK138D1, AK138D1 + Ivonescimab + Carboplatin, AK138D1+ Ivonescimab |
| IvonescimabEnrolled subjects will receive intravenous infusion (IV) of Ivonescimab according to the dosing regimen specified in their cohort. | Drug | AK138D1 + Ivonescimab + Carboplatin, AK138D1+ Ivonescimab |
| CarboplatinEnrolled subjects will receive intravenous infusion (IV) of Carboplatin according to the dosing regimen specified in their cohort. | Drug | AK138D1 + Ivonescimab + Carboplatin |
Primary outcome
Adverse events (AEs)
Time frame: Up to approximately 2 years
Incidence and severity of subjects with adverse events
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR) , assessed by investigator according to RECIST v1.1.
7 secondary outcomes
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
Pharmacokinetics (PK) characteristics
Time frame: Up to approximately 2 years
Anti-drug antibodies (ADA)
Time frame: Up to approximately 2 years
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 29 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK138D1, Ivonescimab and Carboplatin 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 7 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 29 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 Xufang Yu (+86 (0760) 89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. 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 29 Jul 2026.