Clinical Trials Logo

Clinical Trial Summary

This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients.


Clinical Trial Description

This study aimed to prospectively enroll approximately 300 resectable stage II-IIIB (T1-4N0-2M0, excluding T4 with invasion of vital structures and bulky or infiltrative N2) NSCLC patients with histologically confirmed EGFR 19del or L858R mutations. Peripheral blood samples will be collected at baseline before neoadjuvant 3rd-generationEGFR TKI therapy, and ctDNA levels will be quantitatively assessed. For patients with positive baseline ctDNA, peripheral blood will be collected again after 3 weeks of neoadjuvant TKI therapy to assess if ctDNA has turned negative, and HRCT will be performed to evaluate the treatment efficiency simultaneously. In patients with positive baseline ctDNA, for ctDNA-negative patients after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks (Group A). For ctDNA-positive patients after 3 weeks of neoadjuvant TKI treatment, in combination with imaging changes in the lesions, a multidisciplinary team (MDT) evaluation will be conducted. After discussion between the attending physicians and the patient, the subsequent treatment will either continue TKI treatment for 9-12 weeks (Group B), undergo 3 cycles of TKI plus chemotherapy (Group C), or undergo sequential neoadjuvant immunotherapy plus chemotherapy for 3 cycles (Group D) before radical resection surgery.The study intends to evaluate the correlation between the rate of major pathological response (MPR) and ctDNA levels at 3 weeks after TKI treatment, to compare the difference in pathological response between ctDNA-negative and ctDNA-positive groups after 3 weeks of neoadjuvant TKI treatment and to evaluate the guiding value of dynamic ctDNA monitoring during neoadjuvant therapy for optimizing subsequent treatments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06287593
Study type Interventional
Source Zhejiang University
Contact Xuqi Sun, MD
Phone +86-18767186629
Email sunxq@zju.edu.cn
Status Not yet recruiting
Phase N/A
Start date April 15, 2024
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT04989322 - Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC Phase 2
Recruiting NCT03349203 - Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer Phase 2
Not yet recruiting NCT05998993 - Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO) N/A
Recruiting NCT05033691 - A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases N/A
Recruiting NCT05256290 - Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations Phase 1/Phase 2
Withdrawn NCT04464967 - Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers Phase 1/Phase 2
Completed NCT04640870 - The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib
Active, not recruiting NCT04862780 - (SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC Phase 1/Phase 2
Not yet recruiting NCT05110950 - Endobronchial Ultrasound Needle Aspiration With and Without Suction N/A
Completed NCT04965701 - First Line Osimertinib in the Real World: an Inter-regional Prospective Study
Recruiting NCT06352502 - An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis
Terminated NCT05153408 - (HARMONY) Study of BLU-701 in EGFR-mutant NSCLC Phase 1
Not yet recruiting NCT05132985 - Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma Phase 2
Recruiting NCT04504071 - Dacomitinib in Lung Cancer With Uncommon EGFR Mutations Phase 2
Recruiting NCT06109558 - The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC Phase 1/Phase 2
Recruiting NCT05165355 - Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma Phase 2
Recruiting NCT06207292 - Stereotactic Ablative Radiotherapy in Synchronous and Metachronous Oligo-Metastatic Non Small Cell Lung Cancer N/A
Recruiting NCT05573373 - Pamiparib (BGB-290) Was Used in EGFR-TkIs Resistant Non-small Cell Lung Cancer Phase 1
Recruiting NCT03749213 - Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer Phase 2
Recruiting NCT05263947 - Bevacizumab Combined With Double Dose Icotinib in Patients With EGFR Exon 21-L858R Mutation Phase 2