Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

Guangdong Association of Clinical Trials

Status: Enrolling

Conditions: Non Small Cell Lung Cancer

Treatments: Diagnostic Test: Molecular residual disease test

Study type: Observational

Funder types: Other

Identifiers

NCT05457049

CTONG 2201

Details and patient eligibility

About

Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.

Full description

Stage IB-IIIA resected NSCLC patients will undergo two-round MRD tests after operation, first in 3-7 days and second in 1 month after operation. And patients who confirm two-round landmark undetectable MRD will be enrolled. Enrolled patients will be under close MRD and imaging monitoring without any adjuvant therapy.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage IB-IIIA non-small cell cancer patients who after complete resection.
• ≥18 years.
• Two-round MRD tests confirm landmark undetectable MRD.
• Expected survival ≥12 weeks.
• Expected survival ≥12 weeks.
• ECOG PS 1-2.
• Willing to accept MRD monitoring every 3 months for a total of 2 years after operation.

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.).

Trial design

180 participants in 1 patient group

Undetectable MRD

Description:

Stage IB-IIIA NSCLC patients who after complete resection. And patients who maintain MRD negativity in two-round MRD landmark test (first in 3-7 days after surgery, second in 1 months ±7 days after surgery) will be enrolled. And patients will be under close dynamic monitoring at least two years.

Treatment:

Diagnostic Test: Molecular residual disease test