NCT05536505

Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC

Recruiting now Phase 2 Last updated 14 September 2022

What this trial tests

Phase 2 trial testing Adjuvant treatment for MRD positivity in MRD in 180 participants. Currently enrolling.

Timeline

13 September 2022

Primary endpoint
1 October 2025

1 October 2030

Quick facts

Lead sponsor	Guangdong Association of Clinical Trials
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	180
Start date	13 September 2022
Primary completion	1 October 2025
Estimated completion	1 October 2030
Sites	16 locations across China

Drugs / interventions tested

• Adjuvant treatment for MRD positivity

Conditions studied

• MRD — all drugs for MRD →

Sponsor

Guangdong Association of Clinical Trials

Who can join

Adults 18 to 80, any sex, with MRD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ctDNA for the Evaluation and Management of EGFR-Mutant Non-Small Cell Lung Cancer.
   Desai A, Vázquez TA, Arce KM, Corassa M, et al · · 2024 · cited 22× · PMID 38473302 · DOI 10.3390/cancers16050940
2. A comprehensive overview of minimal residual disease in the management of early-stage and locally advanced non-small cell lung cancer.
   Boukouris AE, Michaelidou K, Joosse SA, Charpidou A, et al · · 2025 · cited 9× · PMID 40514443 · DOI 10.1038/s41698-025-00984-9
3. Circulating tumor DNA in clinical trials for solid tumors: Challenges and current applications.
   Parisi C, Tagliamento M, Belcaid L, Aldea M, et al · · 2023 · cited 8× · PMID 40027283 · DOI 10.1016/j.jlb.2023.100007
4. Management of Non-Metastatic Non-Small Cell Lung Cancer (NSCLC) with Driver Gene Alterations: An Evolving Scenario.
   Fuorivia V, Attili I, Corvaja C, Asnaghi R, et al · · 2024 · cited 7× · PMID 39330007 · DOI 10.3390/curroncol31090379
5. Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing.
   Kobayashi S, Nakamura Y, Hashimoto T, Bando H, et al · · 2025 · cited 6× · PMID 39920551 · DOI 10.1007/s10147-024-02683-0
6. Circulating tumor DNA (ctDNA)-based minimal residual disease in non-small cell lung cancer.
   Tang L, Li R, Wen H, Zhou Q, et al · · 2023 · cited 6× · PMID 39171282 · DOI 10.1016/j.pccm.2023.04.001
7. Monitoring of Circulating Tumor DNA and Indication of De-Escalation Adjuvant Targeted Therapy for <i>EGFR</i>-Mutated NSCLC After Complete Resection.
   Dong S, Yan B, Liu SY, Gao X, et al · · 2025 · cited 5× · PMID 39758595 · DOI 10.1016/j.jtocrr.2024.100758
8. Molecular minimal residual disease in resected non-small cell lung cancer (NSCLC): results of specifically designed interventional clinical trials eagerly awaited.
   Denis MG, Herbreteau G, Pons-Tostivint E. · · 2023 · cited 5× · PMID 36895928 · DOI 10.21037/tlcr-22-899