NSCLC Stage IIPhase 2NCT07410975
Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer
A Phase 2 study testing sintilimab+IBI310+chemotherapy in people with NSCLC Stage II and NSCLC Stage III, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage II, NSCLC Stage III
- What is being tested?
- sintilimab+IBI310+chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 10 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient shall sign the informed consent.
- Age ≥ 18 years.
- Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC).
- No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy. Traditional Chinese medicine given for anticancer intent is permitted provided it was discontinued ≥ 2 weeks before first dose.
- Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th.
- Non-squamous NSCLC: no EGFR mutation, ALK rearrangement or any other driver mutation with an approved targeted agent. Squamous NSCLC: no known EGFR mutation, ALK rearrangement or other actionable driver mutation.
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- PD-L1 expression negative (22C3 or E1L3N).
- ECOG performance status 0 or 1.
- Adequate organ function within 7 days before first dose:
- Haemoglobin ≥ 90 g/L (no transfusion within 28 days)
- Absolute neutrophil count ≥ 1.5 × 10⁹/L
- Platelet count ≥ 100 × 10⁹/L (no platelet transfusion or IL-11 within 14 days)
- Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
- Total bilirubin ≤ 1.5 × ULN (≤ 2.5 × ULN in Gilbert's syndrome or hepatic metastases)
- ALT and AST ≤ 3 × ULN
- INR or aPTT ≤ 1.5 × ULN
- FEV> 2L, FEV1> 1L, FEV1/FVC ≥ 70%, DLCO ≥ 70% predicted; or Investigator determination that pulmonary reserve is adequate for planned surgery.
- Fertile female must have a negative serum pregnancy test within 7 days before first dose.
- Fertile female and male patients with female partners of childbearing potential must use a highly effective contraceptive method (annual failure rate < 1 %) from 7 days before first dose until 24 weeks after the last dose.
Who cannot join
- Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery.
- Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/day) or other immunosuppressive agents for ≥ 7 consecutive days within 14 days before first dose. Except for inhaled or topical corticosteroids, or corticosteroid therapy at physiological replacement doses for adrenal insufficiency; short- courses (<7 days) corticosteroid use is permitted for the prevention or treatment of non-autoimmune conditions;
- Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose.
- Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids.
- Presence of any active autoimmune disease or history of autoimmune disease. Except in the following cases: Type 1 diabetes, stable hypothyroidism under hormone replacement therapy, psoriasis or vitiligo not requiring systemic treatment.
- Other malignancy within 5 years before first dose, except for tumors assessed by the investigator as cured.
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- Uncontrolled comorbidities, including:
- Active hepatitis B (HBsAg positive and HBV DNA > 500 IU/mL or > 2000 copies/mL) or hepatitis C (HCV antibody and HCV RNA positive). Subjects with HBV DNA ≤ 500 IU/mL who agree to antiviral prophylaxis are eligible.
- Known HIV infection or history of AIDS.
- Active tuberculosis.
- Active infection requiring systemic antibiotics for > 7 days within 28 days before first dose.
- Clinically significant cardiovascular disease: cerebrovascular accident within 6 months, symptomatic heart failure (NYHA class II-IV), unstable angina or myocardial infarction within 6 months, risk of QTc prolongation or arrhythmia.
- Urine protein qualitative≥ 2+, and 24-hour urine protein test > 1g
- History of allogeneic haematopoietic stem-cell or solid-organ transplantation.
- Hypersensitivity to antibody therapies (≥ grade 3 NCI-CTCAE v6.0), history of anaphylaxis, uncontrolled asthma, or significant drug allergies.
- Pregnancy or lactation.
- Other conditions that may affect the safety or compliance of drug therapy in this study include, but are not limited to, psychiatric disorders, uncontrolled large serosal cavity effusions, or moderate to large serosal cavity effusions requiring repeated drainage (recurring within 2 weeks after intervention), such as pleural effusion, pericardial effusion, or ascites cachexia.
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
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Chang Chen, MD, +86 21 65115006, changchenc@hotmail.com
About this study
Official title: Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer: A Phase II, Single-Arm Clinical Study
This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.
Read the detailed description
Eligible patients were investigator - determined surgical candidates with resectable stage II-IIIB NSCLC, negative PD-L1 expression, no evidence of distant metastasis , and no evidence of unresectable localized tumor extension.
This study plans to enroll 54 patients.Patients are scheduled to receive one preoperative dose of sintilimab plus IBI310 combined with chemotherapy and three doses of sintilimab combined with chemotherapy as neoadjuvant therapy. Surgery will be performed on patients deemed operable by the investigator at least 3 weeks after the last dose of study drug. Following surgery, the investigator will assess the patient's response. Postoperatively, patients may continue receiving standard adjuvant therapy with PD-1 inhibitor for one year.
- Conditions
- NSCLC Stage II, NSCLC Stage III
- Being tested
- sintilimab+IBI310+chemotherapy
- Keywords
- CTLA-4, NSCLC, neoadjuvant
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimab+IBI310+chemotherapyDrug
- Neoadjuvant therapy phase: four planned doses of sintilimab 200 mg intravenous infusion at weeks -12, -9, -6, and -3 (Q3W); one planned dose of IBI310 1 mg/kg intravenous infusion at week -12; four planned doses of chemotherapy at weeks -12, -9, -6, and -3 (Q3W). Non-squamous NSCLC: pemetrexed 500 mg/m² IV over 30 min and carboplatin AUC 5 IV over 120 min or per institutional standard. Squamous NSCLC: nanoparticle albumin-bound paclitaxel 260 mg/m² IV over 30 min and carboplatin AUC 5 IV over 120 min or per institutional standard.
- Surgery phase: At least 3 weeks after the last dose of the study drug , participants deemed operable by the investigator will undergo surgery.
| Study group | Role | What they receive |
|---|---|---|
| sintilimab+IBI310+chemotherapy | Experimental | 1. Neoadjuvant therapy phase: four planned doses of sintilimab 200 mg, intravenous infusion at weeks -12, -9, -6, and -3 (Q3W); one planned dose of IBI310 1 mg/kg intravenous infusion at week -12; four planned doses of chemotherapy at weeks -12, -9, -6, and -3 (Q3W).
Non-squamous NSCLC: pemetrexed 500 mg/m² IV and carboplatin AUC 5 IV. Squamous NSCLC: nab paclitaxel 260 mg/m² IV and carboplatin AUC 5 IV.
2. Surgery phase: At least 3 weeks after the last dose of the study drug , participants deemed operable by the investigator will undergo surgery, and then can continue to receive standard adjuvant therapy for one year. Receives: Drug: sintilimab+IBI310+chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR Rate
Defined as the proportion of patients who have achieved major pathologic response (with ≤10% viable tumor cells) in all patients after surgery.
Measured: about 5 months after enrollment
Secondary outcomes (5)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence and severity of adverse events (according to CTCAE v6.0 criteria), severity and its relationship to the experimental treatment; any abnormal laboratory test results, vital signs and physical examination results, etc.
Measured: From the subject's written consent to participate in the study through 30 days after the final administration of the drug
pCR Rate
Defined as the proportion of all patients who completed treatment and had no invasive viable tumor in both the primary tumor and the sampled lymph nodes after surgery.
Measured: about 5 months after enrollment
Overall Response Rate (ORR)
The proportion of patients who have had a complete response (CR) or partial response (PR) (according to RECIST1.1) after the neoadjuvant therapy.
Measured: 12 weeks
Event Free Survival (EFS)
The time from enrollment to first occurrence of progression, disease recurrence (including local and distant recurrence), or death from any cause is assessed according to RECIST v1.1.
Measured: up to 5 years
Overall Survival (OS)
Defined as the time from enrollment to the participant's death from any cause.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Jan 2026
- Primary completion10 Jun 2028 (estimated)
- Study completion10 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410975
- Sponsor's protocol ID
- STAR-018
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer: A Phase II, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07410975
- Acronym / sponsor ID
- STAR-018
- Conditions
- NSCLC Stage II, NSCLC Stage III
- Keywords
- CTLA-4, NSCLC, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 10 Jun 2028 (estimated)
- Study completion
- 10 Jan 2030 (estimated)
- First posted
- 13 Feb 2026 (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 aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.
Detailed description
Eligible patients were investigator - determined surgical candidates with resectable stage II-IIIB NSCLC, negative PD-L1 expression, no evidence of distant metastasis , and no evidence of unresectable localized tumor extension.
This study plans to enroll 54 patients.Patients are scheduled to receive one preoperative dose of sintilimab plus IBI310 combined with chemotherapy and three doses of sintilimab combined with chemotherapy as neoadjuvant therapy. Surgery will be performed on patients deemed operable by the investigator at least 3 weeks after the last dose of study drug. Following surgery, the investigator will assess the patient's response. Postoperatively, patients may continue receiving standard adjuvant therapy with PD-1 inhibitor for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sintilimab+IBI310+chemotherapy | Experimental | Drug: sintilimab+IBI310+chemotherapy1. Neoadjuvant therapy phase: four planned doses of sintilimab 200 mg, intravenous infusion at weeks -12, -9, -6, and -3 (Q3W); one planned dose of IBI310 1 mg/kg intravenous infusion at week -12; four planned doses of chemotherapy at weeks -12, -9, -6, and -3 (Q3W). Non-squamous NSCLC: pemetrexed 500 mg/m² IV and carboplatin AUC 5 IV. Squamous NSCLC: nab paclitaxel 260 mg/m² IV and carboplatin AUC 5 IV. 2. Surgery phase: At least 3 weeks after the last dose of the study drug , participants deemed operable by the investigator will undergo surgery, and then can continue to receive standard adjuvant therapy for one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The patient shall sign the informed consent.
- Age ≥ 18 years.
- Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC).
- No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy. Traditional Chinese medicine given for anticancer intent is permitted provided it was discontinued ≥ 2 weeks before first dose.
- Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th.
Key exclusion criteria (17 listed)
- Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery.
- Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/day) or other immunosuppressive agents for ≥ 7 consecutive days within 14 days before first dose. Except for inhaled or topical corticosteroids, or corticosteroid therapy at physiological replacement doses for adrenal insufficiency; short- courses (<7 days) corticosteroid use is permitted for the prevention or treatment of non-autoimmune conditions;
- Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose.
- Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids.
- Presence of any active autoimmune disease or history of autoimmune disease. Except in the following cases: Type 1 diabetes, stable hypothyroidism under hormone replacement therapy, psoriasis or vitiligo not requiring systemic treatment.
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 |
|---|---|---|
| sintilimab+IBI310+chemotherapy1. Neoadjuvant therapy phase: four planned doses of sintilimab 200 mg intravenous infusion at weeks -12, -9, -6, and -3 (Q3W); one planned dose of IBI310 1 mg/kg intravenous infusion at week -12; four planned doses of chemotherapy at weeks -12, -9, -6, and -3 (Q3W). Non-squamous NSCLC: pemetrexed 500 mg/m² IV over 30 min and carboplatin AUC 5 IV over 120 min or per institutional standard. Squamous NSCLC: nanoparticle albumin-bound paclitaxel 260 mg/m² IV over 30 min and carboplatin AUC 5 IV over 120 min or per institutional standard. 2. Surgery phase: At least 3 weeks after the last dose of the study drug , participants deemed operable by the investigator will undergo surgery. | Drug | sintilimab+IBI310+chemotherapy |
Primary outcome
MPR Rate
Time frame: about 5 months after enrollment
Defined as the proportion of patients who have achieved major pathologic response (with ≤10% viable tumor cells) in all patients after surgery.
5 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: From the subject's written consent to participate in the study through 30 days after the final administration of the drug
pCR Rate
Time frame: about 5 months after enrollment
Overall Response Rate (ORR)
Time frame: 12 weeks
Event Free Survival (EFS)
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 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 13 Feb 2026.
- 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.
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 sintilimab+IBI310+chemotherapy in people with NSCLC Stage II and NSCLC Stage III, run by Shanghai Pulmonary Hospital, Shanghai, China 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 19 inclusion and 17 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 13 Feb 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 Chang Chen, MD (+86 21 65115006, changchenc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR Rate (time frame: about 5 months after enrollment). 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 13 Feb 2026.