Efficacy and Safety of Toripalimab Adjuvant Therapy in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK) After Complete Resection: a Prospective, Single-arm Study

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country51 target enrollmentMarch 20, 2024

ConditionsNSCLC

InterventionsToripalimab

Overview

Phase: Phase 2
Intervention: Toripalimab
Conditions: NSCLC
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 51
Locations: 1
Primary Endpoint: 3-year DFS rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.

Registry

clinicaltrials.gov

Start Date

March 20, 2024

End Date

March 20, 2031

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subjects will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;
•Male and female, ≥18 years old;
•Primary non-squamous NSCLC confirmed histologically by the central laboratory;
•The subject was clinically confirmed as stage IA2-IB by imaging with tumor lesion size \> 2 cm;
•As confirmed by the central laboratory, the tumor contains no common EGFR mutations and ALK fusion variants;
•The primary NSCLC must be completely resected by surgery, and all lesions must be removed at the end of the surgery.All surgical margins must be negative. Lobectomy can be done with open surgery or thoracoscopic (VATS);
•Central laboratory pathology confirmed solid and/or micropapillary component ≥10%, and/or STAS, and/or pleural invasion, and/or poorly differentiated, and/or complex glands ≥ 10%; PD-L1 TPS ≥ 1% in tumor tissue;
•WHO physical status score is 0\~1;
•Paraffin-embedded sections (10-15 sheets), or wax blocks or fresh frozen tissue for surgical resection of the lesion should be provided;
•Adequate bone marrow reserve or organ function (demonstrated by any of the following laboratory values: absolute neutrophil count ≥1.5×10⁹/L; Platelet count ≥100×10⁹/L; Hemoglobin ≥90 g/L; Alanine aminotransferase ≤ 2.5 ULN; Aspartate aminotransferase ≤2.5 times ULN; Total bilirubin ≤ 1.5 ULN; Serum creatinine ≤1.5 ULN with creatinine clearance ≥60 mL/min \[as measured or calculated by Cockcroft and Gault formulas\]);

Exclusion Criteria

•Exposure to other antitumor therapies before enrollment;
•Patients who only received segmental resection and wedge resection;
•Patients with any history of active autoimmune disease or autoimmune disease;
•Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids;
•Combined with severe heart disease, or combined with New York Heart Association (NYHA) grade 3 or 4 cardiac insufficiency;
•Any evidence of prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or active interstitial lung disease;
•Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, any condition that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV);
•Have received preventive or attenuated vaccines within 4 weeks before the first administration;
•Patients are unsuitable for participation in this research after comprehensive assessment by the researchers.

Arms & Interventions

Toripalimab adjuvant therapy group

Patients must be enrolled within 8 weeks of complete surgical excision and receive Toripalimab at a dose of 240 mg intravenously (IV) once every 3 weeks for a planned duration of 1 years.

Intervention: Toripalimab

Outcomes

Primary Outcomes

3-year DFS rate

Time Frame: From date of randomisation up to approximately 5 years

DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.

Secondary Outcomes

5-year OS rate(From date of randomization up to approximately 5 years)
DFS(From date of randomisation up to approximately 10 years)
OS(From date of randomization up to approximately 10 years)
3-year OS rate(From date of randomization up to approximately 5 years)
Safety and tolerability in overall population(From date of randomisation up to approximately 10 years)