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

  • End date
    Oct 31, 2023
  • participants needed
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 24 October 2021


This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy.


150 eligible subjects will be randomized in a 2:1 ratio (Study treatment Arm: Control Arm = 100 : 50 subjects) to receive pyrotinib or docetaxel monotherapy.

Each treatment cycle is defined as 21 days for subjects in both arms. Treatment regimen of pyrotinib (Study treatment Arm): 400 mg/d (QD) oral pyrotinib will be administered within 30 minutes after completion of a meal.

Treatment regimen of docetaxel (Control Arm): 75 mg/m2 (Q3W) of docetaxel will be administered via intravenous infusion.

In this study, crossover treatment is allowed for subjects in Control Arm. Within the specified time window of each cycle, subjects should complete physical examinations, laboratory tests, quality of life questionnaires and other tests to assess the safety and quality of life of the subjects.

During study treatment, tumor radiological assessments will be performed every 6 weeks (42 7 days) in the first 52 weeks and every 12 weeks (84 7 days) thereafter.

After the end of treatment and safety follow-up, all subjects will be followed for survival (every 56 7 days) until death, withdrawal of informed consent, lost to follow-up, or termination of the study (whichever occurs first).

Condition Non-squamous NSCLC, HER2 Exon 20 Mutation, Non-squamous NSCLC, Non-squamous NSCLC, Non-squamous NSCLC, Non-squamous NSCLC, Non-squamous NSCLC, Non-squamous NSCLC, Non-squamous NSCLC
Treatment docetaxel, Pyrotinib
Clinical Study IdentifierNCT04447118
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on24 October 2021


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Inclusion Criteria

Signed and dated written informed consent which is approved by IRB/EC, willing and able to comply with scheduled treatment, all examinations at study visits, and other study procedures
Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC disease
Before enrollment, a documented confirmed presence of activating mutations in exon 20 of the HER2 gene must be provided. Sufficient tumor tissue samples should be provided to retrospectively confirm the mutation status of the HER2 gene
Must have measureable disease per RECIST v1.1
For advanced NSCLC, patients must have had progressive disease on or after a platinum based chemotherapy, with or without immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) and/or anti-angiogenic drugs. No more than 2 prior lines of systemic therapy are allowed
The laboratory test values must meet the following standards to manifest that the functional level of important organs/systems meets the requirements
Female patient of childbearing potential (WOCBP) and male patient whose - partner is WOCBP must agree to use effective contraception method during the study period

Exclusion Criteria

Malignant tumors with other pathological types
Medical history of other active malignancies within last 5 years
Subjects with active CNS metastases
Previously treated with targeted drugs for HER2 gene mutations,or previously treated with docetaxel
Prior to the first dose of study treatment, patients with severe effusions with clinical symptoms, severe cardiac disease, or severe infection
Prior to the first dose of study treatment, patients with diseases or special conditions that affect drug administration and absorption
Congenital or acquired immunodeficiency
History of allergy to the study drugs or components
Prior to the first dose of study treatment, or during the study period, patients receive or are anticipated to receive continuous strong CYP3A4 inducers or inhibitors, P-gp inhibitors, or medications that are known to cause QT/QTc prolongation
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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