Clinical trial NCT06221670: Toripalimab Therapy After Resection in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 \[as measured or calculated by Cockcroft and Gault formulas\]);
* At least 2 weeks prior to initiation of the study drug, female subjects should be using highly effective contraceptive methods, pregnancy tests must be negative, and there must be no ongoing breastfeeding prior to initiation of the drug
* Subjects voluntarily join this study, with good compliance and cooperation in safety and survival follow-up.

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.

Primary outcomes:
measure: 3-year DFS rate
timeFrame: From date of randomisation up to approximately 5 years
Secondary outcomes:
measure: DFS
timeFrame: From date of randomisation up to approximately 10 years
measure: 3-year OS rate
timeFrame: From date of randomization up to approximately 5 years
measure: 5-year OS rate
timeFrame: From date of randomization up to approximately 5 years
measure: OS
timeFrame: From date of randomization up to approximately 10 years
measure: Safety and tolerability in overall population
timeFrame: From date of randomisation up to approximately 10 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Dongsheng Yue
role: PRINCIPAL_INVESTIGATOR
References: