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A prospective single-arm clinical study on the role of Sintilimab (IBI308) combined with chemotherapy in neoadjuvant therapy of NSCLC in IB-IIIA stage

A prospective single-arm clinical study on the role of Sintilimab (IBI308) combined with chemotherapy in neoadjuvant therapy of NSCLC in IB-IIIA stageA prospective single-arm clinical study on the role of Sintilimab (IBI308) combined with chemotherapy in neoadjuvant therapy of NSCLC in IB-IIIA stage

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023339
Enrollment
Unknown
Registered
2019-05-23
Start date
2019-05-23
Completion date
Unknown
Last updated
2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

treatment group:IBI308 combined with chemotherapy

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Non-small cell lung cancer confirmed by cytology or histology with PD-L1 = 1% of patients; 2. The patient's TNM stage was IB-IIIA (8th edition lung cancer TNM stage); 3. The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard; 4. ECOG PS score is 0 ~ 2; 5. Aged 18-70 years; 6. Expected survival period > three months; 7. Subjects had no major organ dysfunction: blood routine: white blood cells = 4.0 × 10^9 / L, neutrophils = 2.0 × 10^9 / L, platelet count = 100 × 10^9 / L, hemoglobin = 95g / L; liver function: Serum bilirubin was less than 1.5 times the maximum normal value; ALT and AST were less than 1.5 times the maximum normal value; renal function: creatinine clearance was =45 mL/min; cardiac function: basically normal. 8. He has not received any systematic anti-tumor treatment for advanced disease; 9. The patient has good compliance with the treatment and follow-up, can understand the situation of the study and sign the informed consent form. 10. Patients confirmed by histological specimens not eligible for EGFR or ALK targeted therapy (documented evidence of no tumor EGFR-sensitive mutations and no ALK gene rearrangement).

Exclusion criteria

Exclusion criteria: 1. Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease); 2. Pregnant or lactating women; 3. Patients with a history of mental illness that is difficult to control; 4. Patients with allergies and allergies known or suspected to be allergic to any study drug; 5. Systemic treatment required within 2 years prior to first dose Active autoimmune diseases (eg, using a disease-modifying drug, a corticosteroid, or an immunosuppressive agent). Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments; 6. Patients with poor adherence; 7. Researchers believe that it is not appropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
major pathological response;

Countries

China

Contacts

Public ContactYanqiu Zhao

Henan Cancer Hospital

13938252350@163.com+86 13938252350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026