NCT06221670 Toripalimab Therapy After Resection in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK)
| NCT ID | NCT06221670 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2026-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 51 participants in total. It began in 2024-03-20 with a primary completion date of 2026-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Dongsheng Yue
PRINCIPAL INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT06221670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06221670 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06221670 currently recruiting?
Yes, NCT06221670 is actively recruiting participants. Contact the research team at yuedongsheng_cg@163.com for enrollment information.
Where is the NCT06221670 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06221670 clinical trial?
NCT06221670 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Dongsheng Yue at Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 51 participants.