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OpenTrials
Recruiting

NCT Number: NCT04144569

PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC

The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer

Recruiting

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Key information

Conditions

HER2 Insertion Mutation Positive Advanced NSCLC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Advanced non-small cell lung cancer confirmed by histology or cytology
  • HER2 insertion mutation-positive
  • Failure with first-line standard chemotherapy
  • with measurable lesions.

Exclusion criteria

  • no measurable tumor lesions
  • Patients received PD-1 or Pyrotinib before

Treatment and study plan

PD-1 Combined With Pyrotinib

Drug

PD-1 Combined With Pyrotinib

Primary outcomes

  1. PFS

    Time frame: Approximately 1 years

    Progression free survival

Secondary outcomes

  1. ORR

    Time frame: Approximately 1 years

    To measure the patients's overall response rate

  2. OS

    Time frame: Approximately 1 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangyu Zhang, PhD

CONTACT

[email protected]

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. +8613873123436

Sponsors and collaborators

Lead sponsor

Yongchang Zhang

Other

Registry information

Official study title

the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2019
Registry last updated
Sep 19, 2024

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.