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New treatment option for Lung Cancer, Nonsmall Cell
Official title ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC
ClinicalTrials.gov ID: NCT06426511
What this study is testing
What is Toripalimab+Chemotherapy?
Toripalimab+Chemotherapy is an investigational medicine, being studied as a potential treatment for lung cancer, nonsmall cell.
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 study aims to incorporate circulating tumor DNA (ctDNA)-minimal residual disease (MRD) to personalize the administration of consolidation toripalimab therapy in resected stage IB-IIIA non-small-cell lung cancer (NSCLC) after adjuvant therapy. Toripalimab is a humanized monoclonal antibody for human programmed cell death protein 1.
- 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 to 75
You may be able to join if
- people must have undergone complete surgical resection (R0) of their stage IB , II and select IIIA NSCLC according to the AJCC 8th edition staging;
- Squamous or non-squamous NSCLC histology;
- people should be without EGFR or ALK alterations for nonsquamous NSCLC;
- Male and female, aged 18-75 years;
- Surgery for lung cancer must be completed ≤ 60 days prior to study treatment;
You likely can't join if
- Not R0 resection, or metastatic disease.
- people with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the people with non-squamous...
- Previous treatment with systemic antitumor therapy for NSCLC;
- Severe allergic reaction to other monoclonal antibodies;
- people with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not...
- Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen in screening period with HBV-DNA detected higher than the upper...
See the full eligibility criteria
- people must have undergone complete surgical resection (R0) of their stage IB , II and select IIIA NSCLC according to the AJCC 8th edition staging;
- Squamous or non-squamous NSCLC histology;
- people should be without EGFR or ALK alterations for nonsquamous NSCLC;
- Male and female, aged 18-75 years;
- Surgery for lung cancer must be completed ≤ 60 days prior to study treatment;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level);
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;
- Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min;
- Female people should not be pregnant or breast-feeding;
- Written informed consent provided. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study.
- Not R0 resection, or metastatic disease.
- people with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the people with non-squamous NSCLC;
- Previous treatment with systemic antitumor therapy for NSCLC;
- Severe allergic reaction to other monoclonal antibodies;
- people with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I...
- Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); active...
- Vaccination of live vaccine within 30 days prior to the first dose;
- Evidence of clinically active interstitial lung disease;
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- Inability to comply with protocol or study procedures;
- Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac...
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study and may confuse the study results;
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell...
- Women who are pregnant or nursing.
- Ingredients mixed with small cell lung cancer patients.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.