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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Research on the Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via Digital Droplet PCR (ddPCR) From Peripheral Blood in NSCLC Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458726
• Other study ID #: NCC-005374
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2022
• Source: Peking Union Medical College
• Contact: Junling Li, Professor
• Phone: +8613801178891
• Email: lijunling[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR T790M
• Non-small Cell Lung Cancer

Intervention

Drug:
• Osimertinib
Osimertinib or chemotherapy

Locations

Country	Name	City	State
China	Junling Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause	up to 1 year
Secondary	ORR	the sum of CR and PR rates	up to 1 year
Secondary	DCR	the sum of CR ,PR and SD rates	up to 1 year