Small-cell Lung CancerPhase 2NCT06478043
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for SCLC
A Phase 2 study testing ivonescimab and irinotecan liposome in people with Small-cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- ivonescimab and irinotecan liposome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2024to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 18 to 75 years old (at the time of inform consent obtained).
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- Histologically confirmed SCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- SCLC who failed first-line platinum-based chemotherapy with checkpoint inhibitors.
Show all 9Show fewer
- At least one measurable tumor lesion according to RECIST v1.1.
- Adequate organ function.
- 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.
Who cannot join
- Patients with other cancer in 5 years.
- Undergone anti-angiogenic therapy prior to the first dose of study treatment.
- Evidence and history of severe bleeding tendency.
- 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.
- Active central nervous system (CNS) metastases.
- Active infection requiring systemic therapy.
Show all 13Show fewer
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions.
- Active hepatitis B/C, or HIV infection.
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment.
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation.
- History of alcohol abuse, psychotropic substance abuse or drug abuse.
- Pregnant or lactating women.
- Other conditions considered unsuitable for this study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of AK112 Combined With Irinotecan Liposome in Patients With SCLC Who Progressed on Immune Checkpoint Inhibitors and Chemotherapy.
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.
Read the detailed description
Patients will receive ivonescimab at 20 mg/kg intravenously, on days 1 of every 21-day cycle and irinotecan liposome 56.5mg/m^2 intravenously, on days 1 of every 14-day cycle. Treatment will be discontnued in case of the toxicity became intolerable, the investigator determined that there was no further clinical benefit (based on a combination of RECIST 1.1 imaging assessment and clinical status), or the study was withdrawn for other reasons.
- Conditions
- Small-cell Lung Cancer
- Being tested
- ivonescimab, irinotecan liposome
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivonescimabDrug
Also called AK112
20mg/kg, IV, D1, Q3W
irinotecan liposomeDrug
Also called Irinotecan liposome injection
56.5mg/m^2, IV, D1, Q2W
| Study group | Role | What they receive |
|---|---|---|
| ivonescimab and irinotecan liposome | Experimental | Subjects receive ivonescimab plus irinotecan liposome until progression. Receives: Drug: ivonescimab; Drug: irinotecan liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month PFS (progression free survival) rate
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.
Measured: From the day treatment started to 6 months
Secondary outcomes (6)
Incidence of adverse events (AEs)
Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0.
Measured: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
Objective response rate (ORR)
Objective response rate (ORR)is defined as the proportion of subjects with completeresponse(CR)or partial response(PR), based on RECIST v1.1.
Measured: Interval between the date of enrollment and the date of death from any cause, up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks), based on RECIST v1.1.
Measured: Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years
Duration of Response (DOR)
DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
Progression free survival (PFS)
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 due to any cause (whichever occurs first).
Measured: Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 2 years
Overall survival (OS)
OS is the time from the date of randomization or first dosing date to death due to any cause.
Measured: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start16 Oct 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Yun, MD, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478043
- Sponsor's protocol ID
- IRB-2024-543 (IIT)
- Status last verified
- Aug 2026
- First submitted
- 21 Jun 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of AK112 Combined With Irinotecan Liposome in Patients With SCLC Who Progressed on Immune Checkpoint Inhibitors and Chemotherapy.
- ClinicalTrials.gov ID
- NCT06478043
- Acronym / sponsor ID
- IRB-2024-543 (IIT)
- Conditions
- Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 27 Jun 2024 (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 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.
Detailed description
Patients will receive ivonescimab at 20 mg/kg intravenously, on days 1 of every 21-day cycle and irinotecan liposome 56.5mg/m^2 intravenously, on days 1 of every 14-day cycle. Treatment will be discontnued in case of the toxicity became intolerable, the investigator determined that there was no further clinical benefit (based on a combination of RECIST 1.1 imaging assessment and clinical status), or the study was withdrawn for other reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ivonescimab and irinotecan liposome | Experimental | Drug: ivonescimab, Drug: irinotecan liposomeSubjects receive ivonescimab plus irinotecan liposome until progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 75 years old (at the time of inform consent obtained).
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- Histologically confirmed SCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
Key exclusion criteria (13 listed)
- Patients with other cancer in 5 years.
- Undergone anti-angiogenic therapy prior to the first dose of study treatment.
- Evidence and history of severe bleeding tendency.
- 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.
- Active central nervous system (CNS) metastases.
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 |
|---|---|---|
| ivonescimabAlso: AK11220mg/kg, IV, D1, Q3W | Drug | ivonescimab and irinotecan liposome |
| irinotecan liposomeAlso: Irinotecan liposome injection56.5mg/m^2, IV, D1, Q2W | Drug | ivonescimab and irinotecan liposome |
Primary outcome
6-month PFS (progression free survival) rate
Time frame: From the day treatment started to 6 months
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.
6 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
Objective response rate (ORR)
Time frame: Interval between the date of enrollment and the date of death from any cause, up to approximately 2 years
Disease control rate (DCR)
Time frame: Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years
Duration of Response (DOR)
Time frame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
Progression free survival (PFS)
Time frame: Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 2 years
Overall survival (OS)
Time frame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Small-cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ivonescimab and irinotecan liposome in people with Small-cell Lung Cancer, run by Zhejiang Cancer Hospital 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 13 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: finished, as of the sponsor's last update on 27 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month PFS (progression free survival) rate (time frame: From the day treatment started to 6 months). 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 27 Aug 2026.