Personalized toripalimab therapy for lung cancer based on ctDNA analysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to personalize the administration of consolidation toripalimab therapy for patients with resected stage IB-IIIA non-small-cell lung cancer (NSCLC) by utilizing circulating tumor DNA (ctDNA) to identify minimal residual disease (MRD). After standard adjuvant chemotherapy, patients will be monitored for ctDNA levels to determine if they should receive additional toripalimab therapy. The study seeks to compare outcomes between patients with positive ctDNA who receive toripalimab and those with negative ctDNA who are observed without further treatment. This approach is based on emerging evidence that ctDNA can serve as a biomarker for predicting treatment benefit in NSCLC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects 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;
* Subjects 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 subjects 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.

Exclusion Criteria:

* Not R0 resection, or metastatic disease.
* Subjects with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous NSCLC;
* Previous treatment with systemic antitumor therapy for NSCLC;
* Severe allergic reaction to other monoclonal antibodies;
* Subjects 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 diabetes;
* 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 hepatitis C (defined as positive hepatitis C surface antibody in screening period and positive HCV-RNA);
* 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 arrhythmia requiring medication, hepatic, renal, or metabolic disease);
* 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 carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
* Women who are pregnant or nursing.
* Ingredients mixed with small cell lung cancer patients.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Si-Yu Wang, MD — Sun Yat-Sen University Cancer Center
• Study coordinator: Si-Yu Wang, MD
• Email: wangsy@sysucc.org.cn
• Phone: +86 20 87343439

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• SABR with Axitinib and Toripalimab for oligometastatic kidney cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.