ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC
ConditionLung Cancer, Nonsmall Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Toripalimab+Chemotherapy
- Toripalimab+Chemotherapy followed by consolidation toripalimab
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov