Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy
(PYRAMID-1 Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing pyrotinib, an oral medication, in patients with advanced non-squamous NSCLC who have a HER2 exon 20 mutation and did not respond to previous chemotherapy. Pyrotinib aims to block proteins that help cancer cells grow. It was approved in China for HER2-positive breast cancer and has shown promising antitumor activity against HER2-mutant NSCLC.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs that affect how the study drugs work, like strong CYP3A4 inducers or inhibitors, P-gp inhibitors, or medications that cause QT/QTc prolongation.
What data supports the effectiveness of the drug Docetaxel?
Docetaxel has shown impressive results in treating various cancers, including breast, lung, ovarian, prostate, head and neck, gastric, and bladder cancers. It has been found to be as effective or superior to standard treatments, often with a better safety profile, and has demonstrated a survival benefit in several settings.12345
What safety data exists for Docetaxel (Taxotere) in humans?
Docetaxel, also known as Taxotere, has been studied for safety in various cancers. Common side effects include neutropenia (low white blood cell count), hair loss, skin reactions, and fluid retention. In some cases, it has been associated with scleroderma-like illness, a condition affecting the skin and connective tissues.16789
What makes the drug combination of Docetaxel and Pyrotinib unique?
The combination of Docetaxel and Pyrotinib is unique because Docetaxel is a well-known chemotherapy drug that stabilizes microtubules to prevent cancer cell division, while Pyrotinib is a newer drug that targets specific proteins involved in cancer growth. This combination may offer a novel approach by attacking cancer cells through different mechanisms, potentially improving treatment effectiveness.46101112
Research Team
Wei Shi, MD,PhD
Principal Investigator
Jiangsu Hengrui Pharmaceuticals Co.,Ltd
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either pyrotinib or docetaxel monotherapy in 21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Survival Follow-up
Participants are followed for survival every 56 days until death or study termination
Treatment Details
Interventions
- Docetaxel
- Pyrotinib
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jiangsu HengRui Medicine Co., Ltd.
Lead Sponsor