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Sintilimab, IBI310, and Chemotherapy for Resectable Stage II-III NSCLC

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Study Aim

This study aims to evaluate the effectiveness of Sintilimab, IBI310, and Chemotherapy in reducing viable tumor cells to 10% or less in patients with resectable stage II-III Non-Small Cell Lung Cancer (NSCLC) after surgery.

What is being tested

sintilimab+IBI310+chemotherapy

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorShanghai Pulmonary Hospital, Shanghai, China
Study ContactChang Chen, MD
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 10, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on a specific type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that is at stage II-III and can be removed by surgery. The study aims to test the effectiveness of a combination therapy involving Sintilimab, an anti-PD-1 antibody, another drug called Anti-CTLA-4 Antibody (IBI310), and standard chemotherapy. The goal is to improve treatment outcomes for patients who do not express a protein called PD-L1 and have no signs of distant metastasis or unresectable localized tumor extension. The study is important as it could potentially enhance the care for these patients and address current challenges in treating this form of lung cancer. The trial plans to enroll 54 patients. Participants will receive one pre-surgery dose of Sintilimab and IBI310 combined with chemotherapy, followed by three doses of Sintilimab and chemotherapy. Surgery will be performed at least 3 weeks after the last dose. After the surgery, the investigator will evaluate the patient's response to the treatment. If needed, patients may continue to receive standard adjuvant therapy with a PD-1 inhibitor for one year after surgery. The primary outcome measured in this study is the Major Pathologic Response (MPR) rate, which is the proportion of patients who have 10% or less viable tumor cells after surgery.

Official TitleEfficacy 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
NCT07410975
Principal SponsorShanghai Pulmonary Hospital, Shanghai, China
Study ContactChang Chen, MD
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

7 inclusion criteria required to participate
Age ≥ 18 years.
The patient shall sign the informed consent.
Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th.
PD-L1 expression negative (22C3 or E1L3N).
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6 exclusion criteria prevent from participating
Hypersensitivity to antibody therapies (≥ grade 3 NCI-CTCAE v6.0), history of anaphylaxis, uncontrolled asthma, or significant drug allergies.
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group receive a combination of Sintilimab, IBI310, and chemotherapy. This includes four doses of Sintilimab, one dose of IBI310, and four doses of chemotherapy before surgery. The chemotherapy drugs used are pemetrexed and carboplatin for non-squamous NSCLC, and nab paclitaxel and carboplatin for squamous NSCLC.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shanghai Pulmonary Hospital

Shanghai, ChinaOpen Shanghai Pulmonary Hospital in Google Maps
Recruiting
One Study Center