NCT07623356RecruitingPhase 1/2
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer
A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 265 (estimated)
- First submitted
- 28 May 2026
- Start date
- 7 Jul 2026
- Primary completion date
- 18 Jun 2028
- Lead sponsor
- Akeso
- Diseases
- Lung cancer
- NCT number
- NCT07623356
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 265
- From 7 Jul 2026 to the primary completion date, 18 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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
- Presence of active central nervous system (CNS) metastases.
- Other reasons for ineligibility as evaluated by investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.