Toripalimab Combined With SBRT for NSCLC

Non-small Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293690
• Other study ID #: L23-407
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 15, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Juemin Yu
• Phone: 86-15927548511
• Email: yujm96[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age range from 18 to 75 years old, regardless of gender;

2. ECOG behavior status score 0-1 points;

3. Non small cell lung cancer diagnosed pathologically and clinically classified as stage IIA-IIIB (8th AJCC staging standard);

4. Sufficient tumor tissue can be provided for biomarker analysis;

5. Patients with distant metastasis are excluded through CT or PET/CT, and their physical condition is evaluated as acceptable for radical lung cancer surgery;

6. Primary lung lesions are suitable for SBRT treatment;

7. Confirming the absence of EGFR/ALK/ROS-1 sensitive gene mutations through molecular pathological diagnosis of the organization;

8. 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:

1. Pathological findings indicate complex small cell lung cancer, etc;

2. History of previous lobectomy surgery and previous experience with radiotherapy and chemotherapy;

3. 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);

4. 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.);

5. Have active infection or active tuberculosis history requiring systemic treatment;

6. 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;

7. Those who are known to have or combine with other uncontrollable diseases and are unable to receive surgical treatment;

8. Physical examination or clinical trial findings that researchers believe may interfere with the results or increase the risk of treatment complications for patients;

9. 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;

10. 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);

11. History of congenital or acquired immunodeficiency diseases or organ transplantation;

12. Have received any of the following treatments:a Previously received chemotherapy, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or other drugs that synergistically inhibit T cell receptors such as CTLA-4, OX-40, and CD137; Received any investigational medication within 4 weeks prior to the first use of the investigational medication;b Simultaneously enroll in another clinical study, unless it is an observational (non-intervention) clinical study or an intervention clinical study follow-up;c Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the investigational drug;d Having undergone major surgery or severe trauma within 4 weeks before the first use of the investigational drug;

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Lung Cancer

Intervention

Drug:
• Toripalimab
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.
• Toripalimab
Patients received preoperative neoadjuvant therapy: SBRT 12gy on the first day, and Toripalimab (iv 240mg, q3W) on the second day. Two cycles in total.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events (AEs) related to the investigational drug, laboratory test outliers, and serious adverse events (SAEs) determined according to the NCI-CTCAE V5.0 standard	24 hours
Primary	Major pathological remission rate	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.	30 day
Secondary	Complete pathological remission rate	After a complete evaluation of excised lung cancer specimens, including lymph nodes in all sampling areas, there was a lack of any surviving tumor cells when re examining HE slides	30 day
Secondary	disease-free survival(DFS)	The time interval between receiving surgical treatment and tumor recurrence or death due to tumor progression	3 years
Secondary	overall survival	The time interval between receiving surgical treatment and the patient's death due to any reason, and the patient is still alive during the final follow-up, with the survival time ending at the last follow-up.	3 years