A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harbouring EGFR Mutations

Sponsor
Yonsei University
Study ID
NCT04816838
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    \* Osimertinib 80mg once a day(QD) oral(PO) Neoadjuvant Period -If there is no disease progression or unacceptable toxicity, treatment is performed for 2cycles at 1 cycle (28 days) interval Adjuvant Period \- If there is no disease progression of unacceptable toxicity, treatment fis performed for 3years at intervals of 1cycle(28days)

Study Details

Osimertinib is a third-generation EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) for the management of NSCLC(non-small cell lung cancer) harbouring EGFR(Epidermal growth factor receptor) T790M mutation after acquired resistance to previous first-generation EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) therapy. Moreover, osimertinib was approved or the treatment of patients with EGFR(Epidermal growth factor receptor) mutant NSCLC (non small cell lung cancer) in the first-line setting based on the clinical trial. The clinical activity and favorable toxicity profile of osimertinib has led to broadly research into this drug as a strategy to inhibit and prevent drug resistance in EGFR(Epidermal growth factor receptor) mutant NSCLC (non small cell lung cancer). Evidences of benefit from EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) in EGFR(Epidermal growth factor receptor) mutant NSCLC (non small cell lung cancer) patients have been increasing in early stages as well as in advance stages. Therefore, adjuvant or neo adjuvant EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) in operable NSCLC(non small cell lung cancer) patients could improve survival in EGFR(Epidermal growth factor receptor) mutant NSCLC (non small cell lung cancer) patients. Acquired resistance by widespread clinical use has become a hot clinical problem. A variety of target therapies are being developed to overcome tolerance to osimertinib to improve this outcome. This is an approach that should improve the molecular and clinical understanding of the drug resistance. Specifically, we want to investigate innate drug resistance and tumor microenvironment to osimertinib by performing single-cell RNA sequencing (scRNA-seq). and single cell research is obviously needed to develop cancer therapeutic strategies.

Key Dates

Start date
May 10, 2021
Status verified
Aug 2021
Primary completion
Jul 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: N/A(Single Arm)

Primary Outcome Measure

Objective Response Rage (ORR) [ Time Frame: until 2 years ]

Central Contacts

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