Resectable Stage IB-III Non-Squamous Non-Small Cell Lung CancerPhase 2NCT07122687
IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing Pemetrexed, Cisplatin and IBI363 in people with Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- Pemetrexed, Cisplatin and IBI363
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2025to 30 Apr 2030
- 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
- Males and Females, age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed primary non-squamous NSCLC:
- Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);
- No administration of any anti-NSCLC therapy in the pre-operative period;
- Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
- Participants without EGFR mutations or ALK translocation;
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- At least 1 measurable lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Adequate organ function confirmed at screening period.
Who cannot join
- Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;
- Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
- Pancoast tumor;
- Malignant tumor nodule in the contralateral lung lobe;
- Participants with known or suspected brain metastases or other distant metastases;
- Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;
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- Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;
- History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;
- History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;
- History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;
- Active or uncontrolled diseases or conditions;
- History of immunodeficiency disease;
- Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110000
Hongxu Liu, 024-81916272, hongxuliu@qq.com
Jianxing He
About this study
Official title: A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
- Being tested
- Pemetrexed, Cisplatin, IBI363, Carboplatin, Keytruda
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
500 mg/m2 D1 IV Q3W
CisplatinDrug
75 mg/m2 D1 IV Q3W
IBI363Drug
1.5 mg/kg D1 IV Q3W
CarboplatinDrug
AUC 5 mg/ml/min D1 IV Q3W
KeytrudaDrug
200mg D1 IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| IBI363 | Experimental | Neoadjuvant Treatment period: 4 cycles of IBI363 plus platinum-based chemotherapy prior to surgery. Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: IBI363; Drug: Carboplatin |
| Keytruda | Active comparator | Neoadjuvant Treatment period: 4 cycles of Keytruda plus platinum-based chemotherapy prior to surgery. Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) rate
pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Measured: Up to approximately 8 weeks following completion of neoadjuvant treatment
Safety parameters: the incidence of all adverse events (AEs)
Measured: up to 90 days after the last dose
Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)
Measured: up to 90 days after the last dose
Safety parameters: the incidence of immune-related adverse events (irAEs)
Measured: up to 90 days after the last dose
Safety parameters: the incidence of adverse events of special interest (AESIs)
Measured: up to 90 days after the last dose
Safety parameters: the incidence of serious adverse events (SAE)
Measured: up to 90 days after the last dose
Safety parameters: the relatedness of infusion-related reactions (IRRs) to the investigational product and their severity
Measured: up to 90 days after the last dose
Safety parameters: the surgery delay rate
Measured: Up to approximately 8 weeks following completion of neoadjuvant treatment
Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests,, routine urine tests, pregnancy tests，ECG, etc
Measured: up to 90 days after the last dose
Secondary outcomes (5)
Event Free Survival (EFS)
EFS is defined as the time from the first dose to the first determination by the investigator with RECIST v1.1 of inoperable disease progression, postoperative local recurrence or distant metastasis, development of another primary tumor, or death from any cause, whichever occurred first.
Measured: Up to approximately 5 years
Major Pathological Response (mPR) Rate
mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Measured: Up to approximately 8 weeks following completion of neoadjuvant treatment
Objective Response Rate （ORR）Rate
ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria.
Measured: Up to approximately 5 years
Disease Control Rate (DCR) Rate
ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) 、partial response (PR) or stable Disease（SD） according to the RECIST v1.1 criteria.
Measured: Up to approximately 5 years
R0 resection rate
R0 resection rate is defined as negative margins, systematic lymph node dissection or sampling, and tumor-negative highest mediastinal lymph nodes.
Measured: Up to approximately 8 weeks following completion of neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start26 Aug 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Stage IB-III Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122687
- Sponsor's protocol ID
- CIBI363C201
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07122687
- Acronym / sponsor ID
- CIBI363C201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 14 Aug 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 randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI363 | Experimental | Drug: Pemetrexed, Drug: Cisplatin, Drug: IBI363, Drug: CarboplatinNeoadjuvant Treatment period: 4 cycles of IBI363 plus platinum-based chemotherapy prior to surgery. |
| Keytruda | Active comparator | Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: KeytrudaNeoadjuvant Treatment period: 4 cycles of Keytruda plus platinum-based chemotherapy prior to surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and Females, age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed primary non-squamous NSCLC:
- Participants without EGFR mutations or ALK translocation;
- At least 1 measurable lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
Key exclusion criteria (13 listed)
- Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;
- Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
- Pancoast tumor;
- Malignant tumor nodule in the contralateral lung lobe;
- Participants with known or suspected brain metastases or other distant 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 |
|---|---|---|
| Pemetrexed500 mg/m2 D1 IV Q3W | Drug | IBI363, Keytruda |
| Cisplatin75 mg/m2 D1 IV Q3W | Drug | IBI363, Keytruda |
| IBI3631.5 mg/kg D1 IV Q3W | Drug | IBI363 |
| CarboplatinAUC 5 mg/ml/min D1 IV Q3W | Drug | IBI363, Keytruda |
| Keytruda200mg D1 IV Q3W | Drug | Keytruda |
Primary outcome
Pathologic Complete Response (pCR) rate
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Safety parameters: the incidence of all adverse events (AEs)
Time frame: up to 90 days after the last dose
Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)
Time frame: up to 90 days after the last dose
Safety parameters: the incidence of immune-related adverse events (irAEs)
Time frame: up to 90 days after the last dose
Safety parameters: the incidence of adverse events of special interest (AESIs)
Time frame: up to 90 days after the last dose
Safety parameters: the incidence of serious adverse events (SAE)
Time frame: up to 90 days after the last dose
Safety parameters: the relatedness of infusion-related reactions (IRRs) to the investigational product and their severity
Time frame: up to 90 days after the last dose
Safety parameters: the surgery delay rate
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests,, routine urine tests, pregnancy tests，ECG, etc
Time frame: up to 90 days after the last dose
5 secondary outcomes
Event Free Survival (EFS)
Time frame: Up to approximately 5 years
Major Pathological Response (mPR) Rate
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Objective Response Rate （ORR）Rate
Time frame: Up to approximately 5 years
Disease Control Rate (DCR) Rate
Time frame: Up to approximately 5 years
R0 resection rate
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
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 27 Jul 2026.
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.
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 Pemetrexed, Cisplatin and IBI363 in people with Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. 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: looking for participants now, as of the sponsor's last update on 27 Jul 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?
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 xiao zhang (17631117415, kobe.zhang@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) rate (time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment). The study lists 9 primary outcomes in all. 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 Jul 2026.