Efficacy and Safety of Toripalimab Combined With SBRT in the Neoadjuvant Treatment for Operable or Potentially Operable Non-small Cell Lung Cancer in Stage IIA to IIIB

Shanghai Pulmonary Hospital, Shanghai, China1 site in 1 country40 target enrollmentApril 15, 2024

ConditionsNon-small Lung Cancer

InterventionsToripalimab

DrugsToripalimab

Overview

Phase: Phase 2
Intervention: Toripalimab
Conditions: Non-small Lung Cancer
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Enrollment: 40
Locations: 1
Primary Endpoint: Major pathological remission rate
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC

Registry

clinicaltrials.gov

Start Date

April 15, 2024

End Date

June 30, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Responsible Party

Principal Investigator

Deping Zhao

Administrative Director of Thoracic Surgery

Shanghai Pulmonary Hospital, Shanghai, China

Eligibility Criteria

Inclusion Criteria

•Age range from 18 to 75 years old, regardless of gender;
•ECOG behavior status score 0-1 points;
•Non small cell lung cancer diagnosed pathologically and clinically classified as stage IIA-IIIB (8th AJCC staging standard);
•Sufficient tumor tissue can be provided for biomarker analysis;
•Patients with distant metastasis are excluded through CT or PET/CT, and their physical condition is evaluated as acceptable for radical lung cancer surgery;
•Primary lung lesions are suitable for SBRT treatment;
•Confirming the absence of EGFR/ALK/ROS-1 sensitive gene mutations through molecular pathological diagnosis of the organization;
•The main organ functions within 7 days before the first administration meet the following standards:
•a Bone marrow function: hemoglobin ≥ 10.0 g/dL (no blood transfusion received within 28 days before hemoglobin test), absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L (no platelet transfusion or IL-11 treatment received within 14 days prior to platelet count test);b Coagulation function: INR and PT\<1.5 × ULN, APTT ≤ 1.5 × ULN;c Liver function: transaminases (ALT and AST) ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 2.5 in subjects with Gilbert\'s syndrome or liver metastasis) × ULN);d Renal function: serum creatinine clearance rate ≥ 60 mL/min (calculated according to Cockcroft Fault formula);e Adequate lung function: According to the doctor\'s judgment, lung function can meet the requirements of thymectomy surgery.

Exclusion Criteria

•Pathological findings indicate complex small cell lung cancer, etc;
•History of previous lobectomy surgery and previous experience with radiotherapy and chemotherapy;
•Patients with concurrent secondary primary cancer and a history of malignant tumors less than 5 years (excluding completely cured cervical carcinoma in situ or basal or squamous cell skin cancer);
•The patient has any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.);
•Have active infection or active tuberculosis history requiring systemic treatment;
•Those who have combined the following active infectious diseases, including those who are highly positive for hepatitis, known human immunodeficiency virus (HIV) infections, and sexually transmitted diseases such as active syphilis;
•Those who are known to have or combine with other uncontrollable diseases and are unable to receive surgical treatment;
•Physical examination or clinical trial findings that researchers believe may interfere with the results or increase the risk of treatment complications for patients;
•Previous history of interstitial lung disease, drug-induced interstitial disease, or any clinically proven active interstitial lung disease, baseline CT scan reveals the presence of idiopathic pulmonary fibrosis; Uncontrolled large amounts of pleural or pericardial effusion;
•Unstable systemic comorbidities (active infection period, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction occurring within 6 months, severe mental disorders requiring drug control, metabolic diseases of the liver, kidney or other organs, neuropsychiatric disorders such as Alzheimer\'s disease);

Arms & Interventions

SBRT combined with immunochemotherapy

A: Patients received preoperative neoadjuvant therapy: SBRT 12Gy on the first day, and Toripalimab (IV 240mg, q3W) combined with platinum-containing dual drugs on the second day. Two cycles in total.

Intervention: Toripalimab

SBRT combined with immunotherapy

B:Patients received preoperative neoadjuvant therapy: SBRT 12Gy on the first day, and Toripalimab (IV 240mg, q3) on the second day. Two cycles in total.

Intervention: Toripalimab

Outcomes

Primary Outcomes

Major pathological remission rate

Time Frame: 30 day

The percentage of residual live tumor cells in the tumor bed after neoadjuvant therapy is ≤ 10%, regardless of whether there are residual live tumor cells in the lymph nodes.