Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuangdong Association of Clinical Trials

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Stage IB-IIIA NSCLC patients who after complete resection and undetectable landmark MRD.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Molecular residual disease test

    Diagnostic test

    OncoMRD Lung

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Undetectable MRD1 intervention

Trial outcomes

Primary outcomes

1

Two-years disease free survival rates for patients with longitudinal undetectable MRD

The 2-year DFS rate of patients who maintain 2-years undetectable MRD.

Time frame
2 year

Secondary outcomes

1

Two-years disease free survival rates for patients with six months longitudinal undetectable MRD

The 2-year DFS rate of patients who maintain 6-months undetectable MRD.

Time frame
2 year
2

Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD

The 2-year DFS rate of patients who maintain 12-months undetectable MRD.

Time frame
2 year
3

Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD

The 2-year DFS rate of patients who maintain 18-months undetectable MRD.

Time frame
2 year
4

Two-years event-free survival rates for enrolled patients in two years

The events are defined as disease recurrence or detectable MRD.

Time frame
2 year

Other outcomes

Sponsors and contacts

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