Clinical trial · Interventional
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for SCLC
Phase II Study of AK112 Combined With Irinotecan Liposome in Patients With SCLC Who Progressed on Immune Checkpoint Inhibitors and Chemotherapy.
NCT06478043CI-TRIAL-00124178completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan liposome | Drug | — | UNRESOLVED |
| ivonescimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ivonescimab and irinotecan liposome
- description
- Subjects receive ivonescimab plus irinotecan liposome until progression.
- interventionNames
- Drug: ivonescimab
- Drug: irinotecan liposome
Primary outcomes (1)
- measure
- 6-month PFS (progression free survival) rate
- timeFrame
- From the day treatment started to 6 months
- description
- PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death at 6 months.
Secondary outcomes (6)
- measure
- Incidence of adverse events (AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 to 75 years old (at the time of inform consent obtained). 2. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). 3. Histologically confirmed SCLC. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Life expectancy of at least 3 months. 6. SCLC who failed first-line platinum-based chemotherapy with checkpoint inhibitors. 7. At least one measurable tumor lesion according to RECIST v1.1. 8. Adequate organ function. 9. All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment. Exclusion Criteria: 1. Patients with other cancer in 5 years. 2. Undergone anti-angiogenic therapy prior to the first dose of study treatment. 3. Evidence and history of severe bleeding tendency. 4. History of severe active autoimmune disease that has required systemic treatment in the past 2 years, severe drug allergy or have known allergy to any component of the study drugs. 5. Active central nervous system (CNS) metastases. 6. Active infection requiring systemic therapy. 7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions. 8. Active hepatitis B/C, or HIV infection. 9. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment. 10. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation. 11. History of alcohol abuse, psychotropic substance abuse or drug abuse. 12. Pregnant or lactating women. 13. Other conditions considered unsuitable for this study by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.