NSCLC
Conditions
Keywords
MRD, ctDNA
Brief summary
It is a prospective, multicenter, randomized controlled trial to investigate the predictive value of MRD on adjuvant therapy. Stage IA2-II resected NSCLC patients will undergo two-round MRD tests after surgery, first in 3-7 days and second in 1 month after surgery. And patients who confirm two-round landmark undetectable MRD will be enrolled and randomly assigned to the conventional treatment group or the adaptive therapy group . Patients in the the adaptive therapy group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.
Interventions
DRUGStandard Therapy
For patients with negative EGFR/ALK mutation, adjuvant chemotherapy or adjuvant chemotherapy combined with immunotherapy was administered, for patients with positive EGFR/ALK mutation, targeted therapy was administered.
OTHERAdaptive Therapy
Patients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative.
Sponsors
Tianjin Chest Hospital
Peking University First Hospital
Bethune First Hospital of Jilin University
Beijing Friendship Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Liaoning Cancer Hospital & Institute
Geneplus-Beijing Co. Ltd.
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage IA2-II non-small cell cancer patients who after complete resection. * Two-round MRD tests confirm landmark undetectable MRD * Expected survival ≥24 months * ECOG PS 0-1 * Willing to accept MRD monitoring every 3 months for a total of 2 years after surgery
Exclusion criteria
* Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy * Patients with a history of other malignancies in the past 5 years * Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.) or other conditions that investigators considered would limit the ability of the patient to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-years disease free survival rates | 2 years | The 2-year DFS rate of patients in both arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of adjuvant therapy | 2 years | Differences in adjuvant therapy use between the Adaptive Therapy group (no adjuvant therapy if MRD persistently negative and initiation of adjuvant therapy if MRD positive) and the Standard Treatment Group |
| Questionnaire on Quality of Life | 2 years | Differences in the Quality of Life between the Adaptive Therapy group (no adjuvant therapy if MRD persistently negative and initiation of adjuvant therapy if MRD positive) and the Standard Treatment Group, by using Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, V3) |
| Five-years disease free survival rates | 5 years | The 5-year DFS rate of patients in both arms |
Countries
China
Contacts
Primary ContactLuyan Shen, Ph.D.
Outcome results
None listed