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NCT Number: NCT05457049

Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First People's Hospital of Foshan, Foshan, Guangdong, China

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About this study

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. Patients who confirm two-round landmark undetectable MRD will be enrolled to be under close MRD and imaging monitoring without any adjuvant therapy. Patients who are MRD positive during the two-round MRD screening period will receive treatment and follow-up in accordance with Clinical Practice Guidelines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Molecular residual disease test

Diagnostic Test

OncoMRD Lung

Primary outcomes

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

    Time frame: 2 year

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

Secondary outcomes

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

    Time frame: 2 year

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

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

    Time frame: 2 year

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

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

    Time frame: 2 year

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

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

    Time frame: 2 year

    The events are defined as disease recurrence or detectable MRD.

  5. Two-years disease free survival rates for patients who tested positive for MRD and failed screening during the two-round MRD tests.

    Time frame: 2 year

    The 2-year DFS rate of patients who tested positive for MRD and failed screening during the two-round MRD tests.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Guangdong Association of Clinical Trials

Other

Registry information

Official study title

Dynamic Observational Strategy for Stage IB-IIIA Non-Small Cell Lung Cancer Patients After Complete Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2022
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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