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 | Recruiting Phase 2

• 1 other identifier: STAR-018
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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) scheduled for surgery.

Conditions

NSCLC Stage II; NSCLC Stage III

Keywords

CTLA-4; NSCLC; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• MPR Rate

  Defined as the proportion of patients who have achieved major pathologic response (with ≤10% viable tumor cells) in all patients after surgery.

  about 5 months after enrollment

Secondary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  From the subject's written consent to participate in the study through 30 days after the final administration of the drug

• pCR Rate

  about 5 months after enrollment

• Overall Response Rate (ORR)

  12 weeks

• Event Free Survival (EFS)

  up to 5 years

• Overall Survival (OS)

  up to 5 years

Other Outcomes (1)

• Tumor microenvironment and biomakers exploration

  up to 5 years

Study Arms (1)

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.

Drug: sintilimab+IBI310+chemotherapy

Interventions

sintilimab+IBI310+chemotherapy DRUG

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.

sintilimab+IBI310+chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Diabetes Mellitus, Insulin-Dependent, 12

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Chang Chen, MD

CONTACT

+86 21 65115006; changchenc@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 13, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): June 10, 2028
• Study Completion (Estimated): January 10, 2030
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)