Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy in patients with non-small cell lung cancer (PREDICT-ddPCR) - a multicenter collaborative study- (WJOG13119L)

Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy in patients with non-small cell lung cancer (PREDICT-ddPCR) - a multicenter collaborative study- - Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy - a multicenter collaborative study-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040474

Enrollment

360

Registered

2020-05-25

Start date

2020-08-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed non-squamous non-small cell lung cancer 2) Confirmed EGFR mutations (exon 19 deletion, exon 21 L858R) in tumor tissue samples taken after April 2015 3) Confirmed EGFR exon20 T790M negative in pretreatment tumor tissue samples 4) Stage III or IV not suitable to radical radiation therapy. Recurrence after operation or chemoradiotherapy. 5) EGFR-TKI treatment naive, previous treatment with at least one chemotherapy regimen 6) Provision of archival tumor tissue obtained prior to EGFR-TKI treatment

Exclusion criteria

Exclusion criteria: 1) Confirmed EGFR exon19 deletion or exon21 L858R plus other EGFR gene mutations 2) Switching to another EGFR-TKI between different generations

Design outcomes

Primary

Measure	Time frame
Time to treatment failure of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups detected by dd-PCR methods.	—

Secondary

Measure	Time frame
Time to treatment failure between different generations of EGFR-TKIs in patients with or without pretreatment EGFR T790M detected by dd-PCR. Progression free survival of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups by dd-PCR methods. Examination of the appropriate cut-off value of EGFR T790M allele frequency for the efficacy of EGFR-TKIs. T790M mutation detection ability after acquired resistance between Cobas and dd-PCR methods. T790M mutation allele frequency by dd-PCR methods in pretreatment tumor tissue samples between T790M positive and negative groups by Cobas after acquired resistance.	—

Measure

Time frame

Time to treatment failure between different generations of EGFR-TKIs in patients with or without pretreatment EGFR T790M detected by dd-PCR. Progression free survival of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups by dd-PCR methods. Examination of the appropriate cut-off value of EGFR T790M allele frequency for the efficacy of EGFR-TKIs. T790M mutation detection ability after acquired resistance between Cobas and dd-PCR methods. T790M mutation allele frequency by dd-PCR methods in pretreatment tumor tissue samples between T790M positive and negative groups by Cobas after acquired resistance.

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Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results