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New treatment option for NSCLC
Official title Toripalimab Therapy After Resection in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK)
ClinicalTrials.gov ID: NCT06221670
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, being studied as a potential treatment for nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The people 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;
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- The people 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...
- At least 2 weeks prior to initiation of the study drug, female people should be using highly effective contraceptive methods, pregnancy tests must be negative, and there must be no ongoing breastfeeding prior to...
- people voluntarily join this study, with good compliance and cooperation in safety and survival follow-up.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.