Testing AK138D1 Alone or With Ivonescimab in Advanced Lung Cancer
Tests AK138D1, alone or with ivonescimab, in adults with advanced non-small cell lung cancer.
Key facts
- Who runs it
- Akeso
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 265 people, planned
- Started
- 7 Jul 2026
- Expected to end
- 3 Jul 2030
- Type of study
- Interventional, 3 groups
- Treatments tested
- AK138D1
- Ivonescimab
- Carboplatin
- Record updated
- 29 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced non-small cell lung cancer to test AK138D1 alone or together with ivonescimab.
- Age
- 18 to 75 years
- Sex
- Both men and women can join.
- Disease stage
- Stage IIIB/IIIC or IV non-small cell lung cancer (NSCLC) with measurable disease (RECIST 1.1).
Main reasons for not taking part
- Active central nervous system (CNS) metastases
- Untreated active hepatitis B or hepatitis C
- Known active tuberculosis or active syphilis
- Live or attenuated live vaccine within 4 weeks before the first dose
- Known allergy to a study drug or severe reaction to other monoclonal antibodies
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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 take part
- Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study
- 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
- Presence of active central nervous system (CNS) metastases
- Other reasons for ineligibility as evaluated by investigator
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Shanghai East HospitalShanghai, ChinaContact: Caicun ZhouTaking people
About the trial
What the trial wants to find out
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 full original descriptionShow less
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.
The 3 groups in the trial
- AK138D1Treatment being tested
AK138D1 will be administered at pre-specified dose levels.
- AK138D1+ IvonescimabTreatment being tested
AK138D1 and ivonescimab will be administered at pre-specified dose levels.
Treatment: AK138D1 and Ivonescimab
- AK138D1 + Ivonescimab + CarboplatinTreatment being tested
AK138D1, ivonescimab and carboplatin will be administered at pre-specified dose levels.
Treatment: AK138D1, Ivonescimab, and Carboplatin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Testing AK138D1 Alone or With Ivonescimab in Advanced Lung CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07623356, who can take part
- Record updated
- 29 July 2026