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New treatment option for Non-small Cell Lung Cancer
Official title Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05168566
What this study is testing
What is Sutetinib Maleate Capsule?
Sutetinib Maleate Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as Sutetinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least one measurable lesion.
- ECOG score of 0, 1, or 2.
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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 people of childbearing potential to use acceptable methods of birth control.
- 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...
- 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...
- 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 treatment 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).
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Athens, Georgia, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Pinehurst, North Carolina, United States
- Houston, Texas, United States
- Bengbu, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Shengyang, Liaoning, China
- Linyi, Shangdong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Athens, Georgia, United States; Louisville, Kentucky, United States; Baltimore, Maryland, United States; Pinehurst, North Carolina, United States; Houston, Texas, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.