A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

Study Overview
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Brief Summary
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The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).

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 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)

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 Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy) At least one measurable lesion Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 A minimum life expectancy of > 3 months Adequate bone marrow reserve, hepatic, renal, and coagulation function Other inclusion criteria apply for participating in the Study Exclusion Criteria: Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2) Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion >30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is 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 for 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 Any active infection which has not been controlled at screening. Other exclusion criteria apply for participating in the Study

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: Single arm, Open label<br>Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, 80 mg once daily, 28 days for a cycle. | Drug: Sutetinib Maleate Capsule<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | Pre-dose up to approximately 20 months post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response (DoR) |  | Pre-dose up to approximately 20 months post-dose | 
| Disease Control Rate (DCR) |  | Pre-dose up to approximately 20 months post-dose | 
| Progression Free Survival (PFS) |  | Pre-dose up to approximately 20 months post-dose | 
| Time to Tumor Progression (TTP) |  | Pre-dose up to approximately 20 months post-dose | 
| Time to Response (TTR) |  | Pre-dose up to approximately 20 months post-dose | 
| Time to Treatment Failure (TTF) |  | Pre-dose up to approximately 20 months post-dose | 
| Overall Survival (OS) |  | Pre-dose up to approximately 20 months post-dose | 
| 1-year Progression Free Survival | Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP. | Pre-dose up to 1 year post-dose | 
| 1-year Survival | Ratio of surviving participants 1 year after the first dose of IP. | Pre-dose up to 1 year post-dose | 
| Area Under The Curve (AUC) of Sutetinib Maleate Capsule |  | Pre-dose up to 24 hours post-dose | 
| Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule |  | Pre-dose up to 24 hours post-dose | 
| Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule |  | Pre-dose up to 24 hours post-dose | 
| Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule |  | Pre-dose up to 24 hours post-dose | 
| Sutetinib Maleate Capsule half-life (T1/2) |  | Pre-dose up to 24 hours post-dose | 
| Apparent Clearance (CL/f) of Sutetinib Maleate Capsule |  | Pre-dose up to 24 hours post-dose | 
| Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule |  | Pre-dose up to 24 hours post-dose | 
| Number of Participants Experiencing Adverse Events (AE) |  | Pre-dose up to approximately 20 months post-dose | 
| Number of Participants Experiencing Adverse Drug Reactions (ADR) |  | Pre-dose up to approximately 20 months post-dose | 
| Number of Participants Experiencing Serious Adverse Events (SAE) |  | Pre-dose up to approximately 20 months post-dose | 
| Number of Participants Experiencing Srious Adverse Reactions (SAR) |  | Pre-dose up to approximately 20 months post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology, Sutetinib Maleate Capsule, Teligene, Cancer