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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Toripalimab+Chemotherapy
DrugAfter surgical resection, patients received 4 cycle of toripalimab (240 mg) in combination with platinum-based adjuvant treatment. Administration of standard postoperative adjuvant chemotherapy for stage IB disease was not mandatory; decisions about whether patients with IB disease would receive adjuvant chemotherapy were made by the physicians.
Toripalimab+Chemotherapy followed by consolidation toripalimab
DrugAfter surgical resection, patients received 4 cycle of toripalimab (240 mg) in combination with platinum-based adjuvant treatment, and then maintenance treatment with single-agent toripalimab (240 mg) once every 3 weeks for up to 13 cycles. Administration of standard postoperative adjuvant chemotherapy for stage IB disease was not mandatory; decisions about whether patients with IB disease would receive adjuvant chemotherapy were made by the physicians.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Observation for undetectable ctDNA after adjuvant therapyExperimental treatment 1 intervention
Group B: Consolidation toripalimab for detectable ctDNA after adjuvant therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The 2-year DFS rate of ctDNA-MRD guided consolidation toripalimab
Determine if ctDNA-MRD guided consolidation toripalimab has a non-inferior 2-year DFS to direct 13 cycles of consolidation toripalimab therapy. 2-year DFS was defined as the proportion of patients who were disease free at 2 years.
Time frame
Baseline to 24 monthsSecondary outcomes
1
The 2-year OS rate of ctDNA-MRD guided consolidation toripalimab
Determine if ctDNA-MRD guided consolidation toripalimab has a non-inferior 2-year OS to direct 13 cycles of consolidation toripalimab therapy. 2-year OS was defined as the proportion of patients who were alive at 2 years.
Time frame
Baseline to 24 months2
The 2-year DFS in patients with persistently detectable ctDNA
Estimate the 2-year DFS in patients with persistently detectable ctDNA after receiving ≥6 months of consolidation toripalimab.
Time frame
Baseline to 24 months3
Percentage of patients with undetectable ctDNA after consolidation toripalimab.
Percentage of patients with undetectable ctDNA after consolidation toripalimab of 13 cycles.
Time frame
Baseline to 15 months4
Percentage of patients with detectable ctDNA after adjuvant chemotherapy plus toripalimab.
Percentage of patients with detectable ctDNA after 4 cycles of adjuvant chemotherapy plus toripalimab.
Time frame
Baseline to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov