Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in NSCLC

Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Osimertinib; EGFR T790M; Non-small Cell Lung Cancer; ddPCR

Treatments: Drug: Osimertinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05458726

NCC-005374

Details and patient eligibility

About

Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations;
• progression from first or second-generation EGFR-TKI confirmed by radiographic imaging;
• received both NGS test and ddPCR from peripheral blood simultaneously.

Exclusion criteria

• progression from first- or second-generation EGFR-TKIs as adjuvant therapy;
• having received third-generation EGFR-TKIs prior to the gene tests;
• having received NGS test only or ddPCR test only.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Osimertinib

Experimental group

Description:

Osimertinib 80mg po daily

Treatment:

Drug: Osimertinib

Other treatments

Sham Comparator group

Description:

chemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents

Treatment:

Drug: Osimertinib