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Recruiting NCT06924710

Adaptive Therapy for Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD

No phase Interventional NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Therapy, Adaptive Therapy.
Who it may be relevant to
Registry conditions: NSCLC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Multicenter Randomized Controlled Study of Adaptive Therapy in Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD

Overview

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

  • Drug Standard 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.
  • Other Adaptive Therapy
    Patients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative.

Primary outcome measures

  • Two-years disease free survival rates [Time frame: 2 years]
Secondary outcome measures (3)
  • Use of adjuvant therapy [Time frame: 2 years]
  • Questionnaire on Quality of Life [Time frame: 2 years]
  • Five-years disease free survival rates [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Cancer Hospital & Institute — Beijing

Identifiers

NCT: NCT06924710 · 2024KT205 · ZLRK202524

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗