ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC
China80 participantsStarted 2024-12-01
Plain-language summary
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. Toripalimab was approved as a consolidation treatment after perioperative therapy in combination with chemotherapy for resectable stage III NSCLC.
Who can participate
Age range18 Years – 75 Years
SexALL
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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;
* Subje…
What they're measuring
1
The 2-year DFS rate of ctDNA-MRD guided consolidation toripalimab