Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

Detailed Description
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Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective Sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with non-resistant uncommon EGFR mutations

Official Title
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A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Sutetinib Maleate Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years old and above, male or female. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC patients with ≤ 1 prior line of chemotherapy. Confirmation that the tumor harbors a non-resistant uncommon EGFR mutation (tumor tissue biopsy), including one or more of L861Q, G719X and S768I mutations, excluding any other EGFR sensitive mutations and/or oncogenes.. At least one measurable lesion. ECOG score of 0, 1, or 2. A minimum life expectancy of > 3 months. Adequate bone marrow reserve, hepatic, renal and coagulation function. Willingness of all subjects of childbearing potential to use acceptable methods of birth control. Exclusion Criteria: Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment. Any systemic anti-tumor therapy such as chemotherapy, immunotherapy and radiation therapy used within 4 weeks prior to enrollment; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for tumor within 2 weeks prior to enrollment. Use or intake of drugs or foods containing potent inhibitor or inducer of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever was the longer, prior to enrollment. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment. Any unresolved toxicities from prior therapy greater than Grade 1 at the time of screening except alopecia. Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption. Active central nervous system metastases Previous or current interstitial lung disease, radiation pneumonitis which requires hormone therapy, or drug-related pneumonia, idiopathic interstitial pulmonary fibrosis identified in a baseline CT scan; uncontrolled massive pleural or pericardial effusion. Any active infection which has not been controlled at screening. Any serious cardiovascular disease. History of other serious systemic disease not suitable for clinical trial. Participation in other interventional clinical trial 4 weeks prior to enrollment or within 5 half-lives from the last dose of investigational product (whichever is longer). Known alcohol or drug dependence. Mental disorders or poor compliance. Previously received solid organ transplantation or hematopoietic stem cell transplantation. Females who are pregnant or breastfeeding. Known hypersensitivity to the active ingredients or excipients of the investigational product. Have any other primary malignant tumors within 3 years (except some low- risk cancers).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sutetinib Maleate Arm<br>Sutetinib capsules monotherapy | Drug: Sutetinib Maleate Capsule<br>* Study drug to be taken orally with or without food (with food preferred) for up to13 cycles<br>* Other names: Sutetinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Objective response rate (ORR) | Objective response rate (ORR) assessed by IRC | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Duration of response (DoR) |  | 2 Years | 
| Assessment of Disease control rate (DCR) |  | 2 Years | 
| Assessment of Progression free survival (PFS) |  | 2 Years | 
| Assessment of Time to progressive disease |  | 2 Years | 
| Assessment of Time to response |  | 2 Years | 
| Assessment of Time to treatment failure (TTF) |  | 2 Years | 
| Assessment of Overall survival (OS) |  | 2 Years | 
| Assessment of 1-year progression-free survival |  | 1 Year | 
| Assessment of 1-year survival |  | 1 Years | 
| Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). | Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs(SAEs) | 2 Years | 
| Assessment of Peak Plasma Concentration (Cmax) or Area under the plasma concentration versus time curve (AUC) |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant tumor, EGFR mutation, lung cancer