A clinical research to evaluate the safety and efficacy of study drug Pyrotinib compare with Docetaxel for patients with advanced lung cancer
- Conditions
- non-small cell lung cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000951-11-IT
- Lead Sponsor
- Jiangsu Hengrui Medicine Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
1. 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.
2. Male or female, >=18 years old.
3. ECOG PS 0-1 (see APPENDIX 2 for ECOG PS criteria).
4. Have histologically or cytologically confirmed locally advanced (must have been evaluated by the investigator that are not amenable to curable surgery or radiotherapy) or metastatic non-squamous NSCLC disease (Stage IIIB – IV, according to the International Association for the Study of Lung Cancer (IASLC) cancer staging system, 8th edition [APPENDIX 3]).
5. 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. For examples of HER2 (ERBB2) exon 20 mutations see APPENDIX 4.
The tumor tissue samples should be: neutral buffered formalin fixed, paraffin-embedded [FFPE] blocks or at least 6-12 unstained (6-10 surgical biopsies, or at least 12 core needle biopsies) tumor tissue slices, fresh or archived (fresh samples are preferred). For patients who cannot provide the required biopsies, their enrollment can be discussed with the sponsor.
6. Must have measureable disease per RECIST v1.1. The definition of CT or MRI measurable lesion as the target lesion: according to RECIST v1.1, the long diameter of such lesion should be >=10 mm by the spiral CT scan or the short diameter of enlarged lymph nodes >=15 mm; lesions that have previously received local treatment can be used as target lesions after the confirmation of progress according to the RECIST v1.1 standard.
7. 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. Two scenarios of neoadjuvant/adjuvant therapy are allowed: a) subjects who received adjuvant or neoadjuvant platinum based chemotherapy and developed recurrent or metastatic disease within 6 months of completing therapy are eligible; b) subjects with recurrent disease > 6 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum based regimen given to treat the recurrence, are eligible.
8. The laboratory test values must meet the following standards to manifest that the functional level of important organs/systems meets the requirements:
• Hematology (not corrected by blood/blood products transfusion, or transfusion of hematopoietic stimulating factors such as G-CSF/TPO, etc. within 14 days before the test): ANC >=1.5 × 109/L; PLT >=100 × 109/L; Hb >=80 g/L;
• Blood biochemistry (liver function): TBIL <=1.0 × ULN; ALT and/or AST <=1.5 × ULN AND alkaline phosphatase (ALP) <=2.5×ULN.
• Blood biochemistry (renal function): Cr <=1.5 × ULN and CrCL >=50 mL/min (Cockcroft-Gault formula);
9. Female of childbearing potential must have a serum pregnancy test within 7 days before the first dose and the result is negative. Female patient of childbearing potential (WOCBP) and male patient whose partner is WOCBP must agree to use effective contraception method during the study period and within 8 weeks after the last dose (if receiving docetaxel treatment only, after the last dose, 3 months for male patient whose p
1. Target disease exclusion criteria
1) Malignant tumors with other pathological types, such as mixed cancer, double primary cancers;
2) Medical history of other active malignancies within last 5 years; Exceptions: skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, prostate cancer in situ, or cervical carcinoma in situ, for which by the date of the first dose of study drug, at least 2 years of complete remission and no other treatment is needed or expected during the study period.
3) Subjects with active CNS metastases are excluded. Subjects with history or evidence of current leptomeningeal metastases are excluded. Subjects are eligible if CNS metastases are adequately treated (surgery or radiotherapy) and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of <=10 mg daily prednisone (or equivalent).
4) Previously treated with targeted drugs for HER2 gene mutations (including but not limited to trastuzumab and its conjugated drugs, pertuzumab, lapatinib, pyrotinib, neratinib, afatinib, dacomitinib, poziotinib);
5) Previously treated with docetaxel;
6) By the date of first dose of study treatment, the washout period of previous drug treatment / medical intervention does not meet the following requirements:
• anti-tumor drugs such as platinum drugs, other chemotherapy drugs, immune checkpoint inhibitors, etc. (including the study drugs of the same classes in clinical study) >= weeks (or 5 half-lives of the drug, to whichever is shorter);
• anti-tumor traditional Chinese medicine treatment >=2 weeks;
• major surgery (requires hospitalization) >=2 weeks;
• minimally invasive surgery (puncture, biopsy, endoscope, etc.) >=1 week;
• with > 30 Gy non-thoracic radiotherapy >=4 weeks;
• with > 30 Gy thoracic radiotherapy >=24 weeks;
• with <=30 Gy palliative radiotherapy >=2 weeks.
Furthermore, it is required that the adverse event has resolved from the previous drug treatment/medical interventions (except for alopecia or fatigue within NCI-CTCAE v5.0 Grade 1)
2. Medical history exclusion criteria
1) Patients with active (not medically treated) CNS diseases, such as benign brain tumors, benign meningiomas, other leptomeningeal diseases, and poorly controlled (occurs within 6 months prior to the first dose of study treatment) cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, etc). Patients are eligible if the above-mentioned disease has been adequately treated and clinically stable prior to the first dose of study treatment (by radiological assessments [preferred enhanced MRI or CT] and maintained for at least 2 weeks, and the relevant symptoms have been resolved to NCI-CTCAE v5.0 Grade <=1 for at least 2 weeks);
2) Severe cardiac disease, including the following diseases that occur within 12 months prior to the first dose of study treatment: (1) myocardial infarction; (2) heart failure; and disease that occurs within 3 months prior to the first dose of study treatment: (1) severe/unstable angina pectoris; (2) ventricular arrhythmias requiring continuous medication; but controlled atrial arrhythmias after continuous medication is eligible; (3) Grade >=2 myocardial ischemia; (4) Grade >=2 cardiac insufficiency according to New York Heart Association (NYHA) Fun
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method