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

Recruiting now · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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)

Key facts

Study ID

NCT05168566

Run by

Teligene US

People needed

99

Starts

2022-09-01

Expected to finish

2028-12-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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.

You may not qualify 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 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).

Where it is running

• FirstHealth Cancer Center — Pinehurst, North Carolina, United States (enrolling)
• University Cancer & Blood Center — Athens, Georgia, United States (enrolling)
• University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
• OPN Healthcare, Inc. — Glendale, California, United States (enrolling)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• Beijing Chest Hospital — Beijing, Beijing Municipality, China
• The Affiliated Cancer Hospital of Chongqin University — Chongqing, Chongqing Municipality, China
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Wuhan Union Hospital of China — Wuhan, Hubei, China
• Hunan Cancer Hospital — Changsha, Hunan, China
• Jiangsu Province Hospital — Nanjing, Jiangsu, China
• Jilin Cancer Hospital — Changchun, Jilin, China
• The First Affiliated Hospital of China Medical University — Shengyang, Liaoning, China
• Linyi Cancer Hospital — Linyi, Shangdong, China
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China
• Sichuan Cancer Hospital — Chengdu, Sichuan, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
• Baptist Health — Louisville, Kentucky, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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