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

Phase 2

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

• Registration Number: NCT05458726
• Lead Sponsor: Peking Union Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-15
• Status Verified: 2022-07
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-10
• Study First Posted: 2022-07-14
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-26
• Primary Completion: 2022-07-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Osimertinib	Osimertinib	Osimertinib 80mg po daily
Other treatments	Osimertinib	chemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents

Primary Outcome Measures

Name	Time	Method
PFS	up to 1 year	Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
ORR	up to 1 year	the sum of CR and PR rates
DCR	up to 1 year	the sum of CR ,PR and SD rates

Trial Locations

Locations (1)

Junling Li; 🇨🇳 Beijing, Beijing, China