II-IIIB (T3N2) Resectable Non-small Cell Lung CancerPhase 2NCT07241819
Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
A Phase 2 study testing Ivonescimab/surgery and Ivonescimab/chemotherapy/surgery in people with II-IIIB (T3N2) Resectable Non-small Cell Lung Cancer and Perioperative, run by Peking University Cancer Hospital & Institute.
Trial summary
This study is a prospective, II Phase clinical trial designed to evaluate the efficacy and safety of ivonescimab as monotherapy or in combination with platinum-based chemotherapy in the perioperative treatment of resectable non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- II-IIIB (T3N2) Resectable Non-small Cell Lung Cancer, Perioperative
- What is being tested?
- Ivonescimab/surgery and Ivonescimab/chemotherapy/surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Nov 2028
- 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
- Voluntarily sign a written informed consent form;
- Aged ≥ 18 years and ≤ 75 years , both males and females are eligible;
- ECOG PS score of 0 or 1;
- Patients with non-small cell lung cancer confirmed by histopathology or cytology, and with resectable clinical stage II-IIIB (T3N2) (according to the 8th edition of lung cancer TNM staging by the Union for International Cancer Control and the American Joint Committee on Cancer);
- No prior anti-tumor treatment has been received;
- No known EGFR sensitive mutations/ALK gene translocations;
Who cannot join
- Patients with large cell carcinoma, mixed-cell lung cancer, or those with small cell lung cancer components in the mixture;
- Presence of locally advanced unresectable or metastatic disease;
- Palliative local treatment for non-target lesions within 2 weeks before the first administration; receipt of non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first administration; receipt of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first administration.
- Severe infection occurred within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection treated with systemic anti-infective therapy within 2 weeks before the first administration (excluding antiviral therapy for hepatitis B or hepatitis C);
- Major surgical operation or severe trauma occurred within 4 weeks before the first administration, or those with a plan for major surgical operation within 4 weeks after the first administration (determined by the researcher); minor local surgery performed within 3 days before the first administration (excluding peripherally inserted central catheterization and venous access port implantation);
- History of severe bleeding tendency or coagulation dysfunction; presence of clinically significant bleeding symptoms within 1 month before the first administration, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or expectorating ≥ 1 teaspoon of fresh blood or small blood clots, or coughing up only blood without sputum; those with blood-tinged sputum are allowed to enroll), nasal bleeding (excluding epistaxis and retrograde epistaxis); receipt of continuous antiplatelet or anticoagulant therapy within 10 days before the first administration.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluate the Efficacy and Safety of Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
This study is a prospective, II Phase clinical trial designed to evaluate the efficacy and safety of ivonescimab as monotherapy or in combination with platinum-based chemotherapy in the perioperative treatment of resectable non-small cell lung cancer (NSCLC).
Patients are stratified by PD-L1 expression level (TPS ≥50% vs. <50%) and randomized in a 2:1 ratio to differentiated neoadjuvant treatment arms: PD-L1≥50% subgroup: Ivonescimab monotherapy (4 cycles) vs. ivonescimab + platinum-based chemotherapy (4 cycles); PD-L1<50% subgroup: Ivonescimab + 1 cycle of chemotherapy followed by 3 cycles of monotherapy vs. ivonescimab + platinum-based chemotherapy (4 cycles). All patients subsequently receive 13 cycles of ivonescimab as adjuvant maintenance therapy postoperatively.
As the first study to explore a PD-L1-directed chemotherapy de-escalation strategy, this trial aims to reduce treatment toxicity while maintaining efficacy, thereby providing a novel personalized precision therapy pathway for resectable NSCLC.
- Being tested
- Ivonescimab/surgery, Ivonescimab/chemotherapy/surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab/surgeryCombination product
Ivonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
Ivonescimab/chemotherapy/surgeryCombination product
Ivonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)
Ivonescimab/chemotherapy/surgeryCombination product
Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
Ivonescimab/chemotherapy/surgeryCombination product
Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Arm1 PD-L1 TPS≥50% | Experimental | Not described Receives: Combination Product: Ivonescimab/surgery |
| Arm2 PD-L1 TPS≥50% | Active comparator | Not described Receives: Combination Product: Ivonescimab/chemotherapy/surgery |
| Arm3 PD-L1 TPS<50% | Experimental | Not described Receives: Combination Product: Ivonescimab/chemotherapy/surgery |
| Arm4 PD-L1 TPS<50% | Active comparator | Not described Receives: Combination Product: Ivonescimab/chemotherapy/surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response（pCR）rate
pCR is defined as the proportion of subjects who have completed surgery and, after the completion of neoadjuvant therapy, have no residual tumor in the resected primary tumor site and lymph nodes as evaluated by local pathology experts.
Measured: At the time of postoperative pathological assessment，Up to approximately 2 years
Secondary outcomes (5)
Major Pathological response，MPR
MPR is defined as the proportion of patients who have completed surgery and, as evaluated by local pathology experts, have residual viable tumor cells accounting for ≤10% in the resected primary tumor foci and lymph nodes.
Measured: At the time of postoperative pathological assessment，Up to approximately 2 years
R0 resection rate
the proportion of patients who have completed surgery and achieved a pathological complete resection of the primary tumor, as evaluated by the researchers and local pathology experts.
Measured: At the time of postoperative pathological assessment，Up to approximately 2 years
Objective Response Rate，ORR
the proportion of patients whose tumor volume reduction meets the pre-specified criteria (complete response/partial response, CR/PR) and can be maintained for the minimum required duration in accordance with recognized response evaluation criteria (such as RECIST version 1.1 for solid tumors)
Measured: After completion of neoadjuvant therapy and before surgery，Up to approximately 2 years
24 months Event-Free Survival（EFS）%
the time from the first administration of the drug in the Full Analysis Set (FAS) to the occurrence of any of the following events, whichever comes first: disease progression evaluated according to RECIST v1.1, local recurrence, distant metastasis, or death from any cause.
Measured: At 24 months after the first administration of study drug to the subjects
incidence rate of adverse events
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.
- First posted21 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for II-IIIB (T3N2) Resectable Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Nan, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241819
- Sponsor's protocol ID
- 2025YJZ75-ZY01
- Status last verified
- Nov 2025
- First submitted
- 20 Jul 2025
- Last updated
- 21 Nov 2025
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07241819
- Acronym / sponsor ID
- 2025YJZ75-ZY01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 21 Nov 2025 (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 study is a prospective, II Phase clinical trial designed to evaluate the efficacy and safety of ivonescimab as monotherapy or in combination with platinum-based chemotherapy in the perioperative treatment of resectable non-small cell lung cancer (NSCLC).
Patients are stratified by PD-L1 expression level (TPS ≥50% vs. <50%) and randomized in a 2:1 ratio to differentiated neoadjuvant treatment arms: PD-L1≥50% subgroup: Ivonescimab monotherapy (4 cycles) vs. ivonescimab + platinum-based chemotherapy (4 cycles); PD-L1<50% subgroup: Ivonescimab + 1 cycle of chemotherapy followed by 3 cycles of monotherapy vs. ivonescimab + platinum-based chemotherapy (4 cycles). All patients subsequently receive 13 cycles of ivonescimab as adjuvant maintenance therapy postoperatively.
As the first study to explore a PD-L1-directed chemotherapy de-escalation strategy, this trial aims to reduce treatment toxicity while maintaining efficacy, thereby providing a novel personalized precision therapy pathway for resectable NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm1 PD-L1 TPS≥50% | Experimental | Combination Product: Ivonescimab/surgery |
| Arm2 PD-L1 TPS≥50% | Active comparator | Combination Product: Ivonescimab/chemotherapy/surgery |
| Arm3 PD-L1 TPS<50% | Experimental | Combination Product: Ivonescimab/chemotherapy/surgery |
| Arm4 PD-L1 TPS<50% | Active comparator | Combination Product: Ivonescimab/chemotherapy/surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign a written informed consent form;
- Aged ≥ 18 years and ≤ 75 years , both males and females are eligible;
- ECOG PS score of 0 or 1;
- Patients with non-small cell lung cancer confirmed by histopathology or cytology, and with resectable clinical stage II-IIIB (T3N2) (according to the 8th edition of lung cancer TNM staging by the Union for International Cancer Control and the American Joint Committee on Cancer);
- No prior anti-tumor treatment has been received;
Key exclusion criteria (6 listed)
- Patients with large cell carcinoma, mixed-cell lung cancer, or those with small cell lung cancer components in the mixture;
- Presence of locally advanced unresectable or metastatic disease;
- Palliative local treatment for non-target lesions within 2 weeks before the first administration; receipt of non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first administration; receipt of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first administration.
- Severe infection occurred within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection treated with systemic anti-infective therapy within 2 weeks before the first administration (excluding antiviral therapy for hepatitis B or hepatitis C);
- Major surgical operation or severe trauma occurred within 4 weeks before the first administration, or those with a plan for major surgical operation within 4 weeks after the first administration (determined by the researcher); minor local surgery performed within 3 days before the first administration (excluding peripherally inserted central catheterization and venous access port implantation);
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 |
|---|---|---|
| Ivonescimab/surgeryIvonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles) | Combination product | Arm1 PD-L1 TPS≥50% |
| Ivonescimab/chemotherapy/surgeryIvonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles) | Combination product | Arm3 PD-L1 TPS<50% |
| Ivonescimab/chemotherapy/surgeryIvonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles) | Combination product | Arm2 PD-L1 TPS≥50% |
| Ivonescimab/chemotherapy/surgeryIvonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles) | Combination product | Arm4 PD-L1 TPS<50% |
Primary outcome
Pathological Complete Response（pCR）rate
Time frame: At the time of postoperative pathological assessment，Up to approximately 2 years
pCR is defined as the proportion of subjects who have completed surgery and, after the completion of neoadjuvant therapy, have no residual tumor in the resected primary tumor site and lymph nodes as evaluated by local pathology experts.
5 secondary outcomes
Major Pathological response，MPR
Time frame: At the time of postoperative pathological assessment，Up to approximately 2 years
R0 resection rate
Time frame: At the time of postoperative pathological assessment，Up to approximately 2 years
Objective Response Rate，ORR
Time frame: After completion of neoadjuvant therapy and before surgery，Up to approximately 2 years
24 months Event-Free Survival（EFS）%
Time frame: At 24 months after the first administration of study drug to the subjects
incidence rate of adverse events
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivonescimab/surgery and Ivonescimab/chemotherapy/surgery in people with II-IIIB (T3N2) Resectable Non-small Cell Lung Cancer and Perioperative, run by Peking University Cancer Hospital & Institute.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Nan Wu (+86139 1015 4426, nanwu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response（pCR）rate (time frame: At the time of postoperative pathological assessment，Up to approximately 2 years). 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 21 Nov 2025.