Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer

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

Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer (NCT07410975) is a Phase 2 interventional studying NSCLC Stage II and NSCLC Stage III, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against NSCLC Stage II and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 54 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused NSCLC Stage II subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

INCLUSION CRITERIA 1. The patient shall sign the willing to sign a consent form. 2. Age ≥ 18 years. 3. diagnosed by tissue sample (biopsy-confirmed) non-small-cell lung cancer (NSCLC). 4. 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. 5. Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th. 6. 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. 7. PD-L1 expression negative (22C3 or E1L3N). 8. You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. 9. your organs (liver, kidneys, etc.) are working well enough based on blood tests 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) - kidney function (creatinine clearance) at least 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. 10. Fertile female must have a negative serum pregnancy test within 7 days before first dose. 11. 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. EXCLUSION CRITERIA 1. Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

INCLUSION CRITERIA 1. The patient shall sign the informed consent. 2. Age ≥ 18 years. 3. Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC). 4. 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. 5. Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th. 6. 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. 7. PD-L1 expression negative (22C3 or E1L3N). 8. ECOG performance status 0 or 1. 9. 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. 10. Fertile female must have a negative serum pregnancy test within 7 days before first dose. 11. 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. EXCLUSION CRITERIA 1. Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery. 2. 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; 3. Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose. 4. Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids. 5. 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. 6. Other malignancy within 5 years before first dose, except for tumors assessed by the investigator as cured. 7. 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 8. History of allogeneic haematopoietic stem-cell or solid-organ transplantation. 9. Hypersensitivity to antibody therapies (≥ grade 3 NCI-CTCAE v6.0), history of anaphylaxis, uncontrolled asthma, or significant drug allergies. 10. Pregnancy or lactation. 11. 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.

Treatments Being Tested

DRUG

sintilimab+IBI310+chemotherapy

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 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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07410975), the sponsor (Shanghai Pulmonary Hospital, Shanghai, China), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07410975 clinical trial studying?

Who can participate in NCT07410975?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07410975?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07410975. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07410975. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.