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Small Cell Lung CancerPhase 2NCT06769971

Phase II Study of Ivonescimab and Cadonilimab in Combination with Chemotherapy in Patients with ES-SCLC

A Phase 2 study testing Ivonescimab, Cadonilimab and Etoposide in people with Small Cell Lung Cancer, run by Sichuan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase II study. All patients are treatment naive extensive stage small cell lung cancer(ES-SCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of Ivonescimab and Cadonilimab in combination with chemotherapy in patients with… 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, Cadonilimab and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Feb 2025to 31 Dec 2027
Phase
Phase 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

  • 1.Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed； 2.18 to 75 years old (at the time of inform consent obtained)； 3.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1； 4.Have a life expectancy of at least 3 months； 5.Have histologically- or cytologically-confirmed diagnosis of Extensive Stage SCLC； 6.Had not received previous systemic therapy; Or ES-SCLC patients who had received definitive chemoradiotherapy for limited-stage small-cell lung cancer but had disease progression > 6 months earlier; 7.Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator； 8.Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy； 9.Have adequate organ function； 10.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

  • Active malignancies within the past 5 years, with the exception of tumors in this study and cured local tumors；
  • Received palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose；
  • Subjects who received any prior treatments targeting the mechanism of tumor immunity；
  • Subjects who received any prior anti-angiogenic therapy；
  • Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels；
  • Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment；
Show all 13Show fewer
  • Symptomatic metastases of the central nervous system；
  • Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage；
  • History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea) within 6 months before the first study drug administration；
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);
  • History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment;
  • Severe infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection that has received systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C)；
  • Concurrent enrollment in another clinical study, unless it is a noninterventional clinical study or the follow-up period of the interventional study is more than 4 weeks from the last dose of the prior clinical study or more than 5 half-lives of the prior study drug, whichever is shorter.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ge Gao, PhD contact

86（028）85421606

gg1023@foxmail.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Ge Gao, PhD, 86（028）85421606, gg1023@foxmail.com

    Recruiting

Other trials in China

About this study

Official title: Phase II Study of Ivonescimab (PD1/VEGF Bispecific) and Cadonilimab（PDL1/CTLA4 Bispecific）in Combination with Etoposide and Carboplatin As First-line Therapy in Patients with Extensive Stage Small Cell Lung Cancer

This is a phase II study. All patients are treatment naive extensive stage small cell lung cancer(ES-SCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of Ivonescimab and Cadonilimab in combination with chemotherapy in patients with ES-SCLC.

Being tested
Ivonescimab, Cadonilimab, Etoposide, Carboplatin
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

    20mg/kg，IV infusion，Day1，Q3W

  • CadonilimabDrug

    10mg/kg，IV infusion，Day8，Q6W

  • EtoposideDrug

    100mg/kg，IV infusion，Day1-3，Q3W

  • CarboplatinDrug

    AUC 5，IV infusion，Day1，Q3W

Study groups in NCT06769971
Study groupRoleWhat they receive
ES-SCLC :Ivonescimab and Cadonilimab plus ChemotherapyExperimentalSubjects receive Ivonescimab+Cadonilimab + Etoposide+Carboplatin for 4 cycles followed by Ivonescimab and Cadonilimab until progression.
Receives: Drug: Ivonescimab; Drug: Cadonilimab; Drug: Etoposide; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Measured: Up to approximately 2 years

  2. Safety

    Grade 3-4 AEs

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. DCR

    Measured: Up to approximately 2 years

  2. DOR

    Measured: Up to approximately 2 years

  3. TTR

    Measured: Up to approximately 2 years

  4. PFS

    Measured: Up to approximately 2 years

  5. OS

    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.

  1. First posted10 Jan 2025
  2. Study start1 Feb 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06769971
Sponsor's protocol ID
HX-AK112-02
Status last verified
Jan 2025
First submitted
6 Jan 2025
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivonescimab, Cadonilimab and Etoposide in people with Small Cell Lung Cancer, run by Sichuan University 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 1 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: looking for participants now, as of the sponsor's last update on 10 Jan 2025. 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?

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 Ge Gao, PhD (86（028）85421606, gg1023@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (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?

On the ClinicalTrials.gov record for NCT06769971.

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 10 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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