Toripalimab treatment for high-risk early-stage lung cancer after surgery

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

This study is testing if the immunotherapy drug Toripalimab can help prevent lung cancer from coming back in patients who have just had surgery for early-stage non-small cell lung cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (other)
• Drugs / interventions: radiation, Toripalimab
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06221670 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Toripalimab, an immunotherapy drug, in patients with completely resected non-small cell lung cancer (NSCLC) at high risk of recurrence. The study focuses on individuals with stage IA2-IB non-squamous NSCLC who do not have common EGFR mutations or ALK fusion variants. Participants will receive Toripalimab after their surgical treatment to assess its potential benefits in preventing cancer recurrence. The trial is conducted at a single center, ensuring a controlled environment for monitoring outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with completely resected stage IA2-IB non-squamous NSCLC and no common EGFR or ALK alterations.

Not a fit: Patients with common EGFR mutations or ALK fusion variants may not benefit from this treatment approach.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence in high-risk NSCLC patients.

How similar studies have performed: While this approach is being explored in this specific context, similar immunotherapy strategies have shown promise in other cancer types, indicating potential for success.

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Dongsheng Yue — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Dongsheng Yue

Conditions: NSCLC