Lung Cancer Clinical Trial
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
Summary
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.
Full Description
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).
Eligibility Criteria
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.
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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 11 Locations for this study
Orange California, 92868, United States More Info
Principal Investigator
Sacramento California, 95817, United States More Info
Principal Investigator
New York New York, 10021, United States More Info
Principal Investigator
Canton Ohio, 44718, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
Spokane Washington, 99208, United States More Info
Principal Investigator
St Leonards Saint Leonards, , Australia More Info
Principal Investigator
Fitzroy , , Australia More Info
Principal Investigator
North Adelaide , , Australia More Info
Principal Investigator
Edegem , , Belgium More Info
Principal Investigator
Leuven , , Belgium More Info
Principal Investigator
Hefei Anhui, , China More Info
Principal Investigator
Beijing Beijing, , China More Info
Principal Investigator
Beijing Beijing, , China More Info
Principal Investigator
Beijing Beijing, , China More Info
Principal Investigator
Chongqing Chongqing, , China More Info
Principal Investigator
Guangzhou Guangdong, , China More Info
Principal Investigator
Cangzhou Hebei, , China More Info
Principal Investigator
Ha'erbin Heilongjiang, , China More Info
Principal Investigator
Zhengzhou Henan, , China More Info
Principal Investigator
Changsha Hunan, , China More Info
Principal Investigator
Yangzhou Jiangsu, , China More Info
Principal Investigator
Nanchang Jiangxi, , China More Info
Principal Investigator
Hohhot Neimenggu, , China More Info
Principal Investigator
Jinan Shandong, , China More Info
Principal Investigator
Shanghai Shanghai, , China More Info
Principal Investigator
Shanghai Shanghai, , China More Info
Principal Investigator
Chengdu Sichuan, , China More Info
Principal Investigator
Yibin Sichuan, , China More Info
Principal Investigator
Tianjin Tianjin, , China More Info
Principal Investigator
Kunming Yunnan, , China More Info
Principal Investigator
Hangzhou Zhejiang, , China More Info
Principal Investigator
Hangzhou Zhejiang, , China More Info
Principal Investigator
Taizhou Zhejiang, , China More Info
Principal Investigator
Creteil , , France More Info
Principal Investigator
Marseille cedex 20 , , France More Info
Principal Investigator
Paris , , France More Info
Principal Investigator
Dresden , , Germany More Info
Principal Investigator
Kempten , , Germany More Info
Principal Investigator
Oldenburg , , Germany More Info
Principal Investigator
Aviano , , Italy More Info
Principal Investigator
Catania , , Italy More Info
Principal Investigator
Meldola (fc) , , Italy More Info
Sub-Investigator
Varese , , Italy More Info
Principal Investigator
Seoul Bundang, , Korea, Republic of More Info
Principal Investigator
Gyeonggi-do , , Korea, Republic of More Info
Principal Investigator
Seoul , , Korea, Republic of More Info
Principal Investigator
Seoul , , Korea, Republic of More Info
Principal Investigator
Seoul , , Korea, Republic of More Info
Principal Investigator
Lublin , , Poland More Info
Principal Investigator
St. Petersburg Saint Petersburg, , Russian Federation More Info
Principal Investigator
Arkhangelsk , , Russian Federation More Info
Principal Investigator
Moscow , , Russian Federation More Info
Principal Investigator
Saint Petersburg , , Russian Federation More Info
Principal Investigator
Saint Petersburg , , Russian Federation More Info
Principal Investigator
Saint Petersburg , , Russian Federation More Info
Principal Investigator
Barcelona Badalona, , Spain More Info
Principal Investigator
Barcelona Badalona, , Spain More Info
Principal Investigator
Madrid , , Spain More Info
Principal Investigator
Madrid , , Spain More Info
Principal Investigator
Malaga , , Spain More Info
Principal Investigator
Sevilla , , Spain More Info
Principal Investigator
Valencia , , Spain More Info
Principal Investigator
Taoyuan City , , Taiwan More Info
Principal Investigator
Adana , , Turkey More Info
Principal Investigator
Istanbul , , Turkey More Info
Principal Investigator
Keçiören , , Turkey More Info
Principal Investigator
Konya , , Turkey More Info
Principal Investigator
How clear is this clinincal trial information?