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OpenTrials
Completed

NCT Number: NCT02575560

Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.

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Key information

Conditions

EGFR-TKI Resistant Mutation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

About this study

1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.

Exclusion criteria

  • liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.

Treatment and study plan

history data

Other

history data of PFS after 1st line or second line theray

Primary outcomes

  1. Progression Free Survival Time (PFS)

    Time frame: an average 1 year

Secondary outcomes

  1. Overall Response Rate(ORR)

    Time frame: an average half year

  2. Overall Survival Time (OS)

    Time frame: an average 2 year

Sponsors and collaborators

Lead sponsor

Qingdao Central Hospital

Other

Registry information

Official study title

High Dose Weekly Use First-generation EGFR-TKI Instead of Daily Regular Dose in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2015
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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