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Pyrotinib combined with thalidomide in advanced non-small-cell lung cancer patients harboring HER2 exon 20 insertions (PRIDE): protocol of an open-label, single-arm phase II trial.

Author: AiXinghao, ChenZhiwei, JianHong, LiZiming, LuShun, SongZhengbo, YuYongfeng, ZhouZhen

Clinical Trial ProtocolA plan for conducting a clinical trial. It describes in detail the purpose, design, methodology, and statistical considerations of the trial, ensuring the transparency and consistency of the trial.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Overview

Standard therapy for human epidermal growth factor receptor 2 (HER2)-mutant non-small-cell lung cancer (NSCLC) is lacking. This article discusses the limitations of current treatment options and explores the potential of emerging therapies, such as trastuzumab deruxtecan, pyrotinib, and thalidomide, for treating HER2-mutant NSCLC. The article also addresses the challenges of pyrotinib-related diarrhea and highlights the potential of thalidomide in mitigating gastrointestinal toxicity.
Paper Details　
Original Abstract of the Article :
Standard therapy for human epidermal growth factor receptor 2 (HER2)-mutant non-small-cell lung cancer (NSCLC) is lacking. The clinical benefits with pan-HER inhibitors (afatinib, neratinib, and dacomitinib), anti-HER2 antibody drug conjugate (ADC) trastuzumab emtansine, and an emerging irreversible...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8444597/

データ提供：米国国立医学図書館（NLM）

A Phase II Trial of Pyrotinib Combined with Thalidomide for HER2 Exon 20 Insertion-Positive NSCLC

This protocol outlines an open-label, single-arm phase II trial investigating the efficacy of pyrotinib combined with thalidomide in patients with advanced non-small-cell lung cancer (NSCLC) harboring HER2 exon 20 insertions. The trial aims to evaluate the safety, tolerability, and antitumor activity of this combination therapy.

Addressing the Need for Effective HER2-Mutant NSCLC Therapy

The current standard treatment for HER2-mutant NSCLC is lacking, with modest clinical benefits observed with available therapies. This trial aims to address the urgent need for effective treatment options for this specific patient population. The trial will investigate the efficacy of pyrotinib, a novel EGFR/HER2 dual tyrosine kinase inhibitor, combined with thalidomide, an antiangiogenic and immunomodulatory agent, in patients with HER2 exon 20 insertions. The combination therapy seeks to enhance antitumor activity while mitigating potential side effects.

Potential for a Novel Therapeutic Approach

This trial explores a novel combination therapy for HER2-mutant NSCLC, leveraging the complementary mechanisms of action of pyrotinib and thalidomide. The study holds the potential to significantly advance the treatment of this challenging cancer. It’s like exploring a new oasis in the desert of lung cancer research, potentially offering a refreshing source of hope for patients with HER2-mutant NSCLC.

Dr.Camel's Conclusion

This protocol outlines a promising phase II trial investigating a novel combination therapy for HER2-mutant NSCLC. The research aims to evaluate the efficacy and safety of pyrotinib combined with thalidomide, potentially leading to a significant breakthrough in the treatment of this challenging cancer. It’s like embarking on a new expedition in the desert of cancer research, seeking to uncover new therapeutic strategies and bring relief to patients in need.

Date :
  1. Date Completed 2021-10-15
  2. Date Revised 2021-10-15
Further Info :

Pubmed ID

34530760

DOI: Digital Object Identifier

PMC8444597

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SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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