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

Completed · Phase 3

Conditions studied: Non-squamous NSCLC, HER2 Exon 20 Mutation

In brief

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.

Key facts

Study ID

NCT04447118

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

151

Starts

2020-09-11

Expected to finish

2024-12-06

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• ECOG PS 0-1.
• 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.

You may not qualify if…

• 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.

Where it is running

• University of California (UC) Davis Comprehensive Cancer Center — Sacramento, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Florida Cancer Specialists South Divisio — Fort Myers, Florida, United States
• Florida Cancer Specialists North Divisio — St. Petersburg, Florida, United States
• University of Kansas Medical Center (KUMC) — Kansas City, Kansas, United States
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Summit Cancer Centers - North Spokane — Spokane, Washington, United States
• Royal North Shore Hospital — St Leonards, Saint Leonards, Australia
• Border Medical Oncology — Albury, Australia
• St Vincent's Hospital Melbourne — Fitzroy, Australia
• Sir Charles Gairdner Hospital — Nedlands, Australia
• Calvary North Adelaide Hospital — North Adelaide, Australia
• Antwerp University Hospital (UZA) — Edegem, Belgium
• University Hospital Gent — Ghent, Belgium
• University Hospital (UZ) Leuven — Leuven, Belgium
• the Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
• beijing chest hospital,Capital medical university — Beijing, Beijing Municipality, China
• Peking university Cancer Hospital — Beijing, Beijing Municipality, China
• The second affiliated hospital of ChongQing medical university — Chongqing, Chongqing Municipality, China
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, Guangdong, China
• Cangzhou Hospital of Integrated Tcm-Wm.Hebei — Cangzhou, Hebei, China
• University of California - Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

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