Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age28-75
SponsorGuangdong Association of Clinical Trials
About this trial
This is a multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after neoadjuvant immunotherapy combined with chemotherapy. The study is being conducted at the Third People's Hospital of Chengdu and the Guangdong Provincial People's Hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent prior to the initiation of any trial-related procedures.
Male or female aged ≥18 years and ≤75 years.
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy.
Disqualifiers
Diagnosis of any malignancy other than non-small cell lung cancer within 5 years prior to the first dose (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely resected).
Received adjuvant radiotherapy prior to dosing.
Patients who underwent pneumonectomy.
Currently participating in an interventional clinical study or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.
Trial design
Design model
Single group
Treatments tested in this trial
Sintilimab
DrugPatients who met the inclusion criteria were treated with adaptive adjuvant sintilimab therapy guided by MRD. Patients should test twice at postoperative days 3 to 7 and again at postoperative day 28 (±3 days). The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD tests or a single positive MRD test will be enrolled in the MRD+ treatment cycle：they will receive adjuvant treatment with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up visits will be conducted every 3 months, during which chest CT scans and MRD testing will be performed. If MRD becomes negative, treatment will be discontinued and the participant will be monitored. If MRD remains positive, treatment with sintilimab will continue. Participants with two consecutive negative MRD tests will be enrolled in the MRD- treatment cycle：they will undergo follow-up observation only. Follow-up visits will be conducted every 3 months
Treatment groups
115 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year EFS rate
Event-free survival (EFS) is defined as the time from the date of randomization (or the start of treatment) to the first occurrence of any of the following events: disease progression, local or distant recurrence, or death due to any cause. If a patient does not experience any of these events within 2 years, they are considered to have achieved 2-year EFS.
Time frame
2 year after treatment initiationSecondary outcomes
1
mEFS
The median Event-Free Survival (mEFS) is defined as the median time from the date of randomization or the initiation of treatment to the first occurrence of a prespecified event, such as disease progression, death, or change in treatment regimen.
Time frame
From enrollment to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)2
2-year OS rate
The 2-year Overall Survival (OS) rate is defined as the proportion of patients who remain alive at the specific time point of 2 years from the date of randomization or the initiation of treatment.
Time frame
24 months3
mOS
The median overall survival (mOS) is defined as from date of enrollment until the date of first documented date of death from any cause, whichever came first, assessed up to 40 months, at which the survival rate is 50%.
Time frame
OS is defined as the time from enrollment to death, regardless of disease recurrence, assessed up to 100 months4
AEs
Safety and tolerability will be assessed by the incidence of adverse events (AEs), serious adverse events (SAEs), immune-related adverse events (irAEs), deaths, and laboratory abnormalities.
Time frame
24 monthsOther outcomes
1
Analyze the proportion of the four types of pathological response (1%-5% irRVT vs. >5%-30% irRVT vs. >30%-80% irRVT vs. >80% irRVT) and their correlation with median event-free survival (mEFS).
Proportion of the four types of RVT results Assessment of the relationship between different RVT results and median event-free survival (mEFS)
Time frame
From enrollment to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangdong Association of Clinical Trials
Lead sponsor
Zunyi Medical College
Collaborator
Suining Central Hospital
Collaborator
Shenzhen Second People's Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov