Evaluating Sutetinib for Advanced Lung Cancer

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)

This study is testing if a new drug called Sutetinib can help people with advanced lung cancer that has certain rare mutations feel better and improve their treatment outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Teligene US (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Sutetinib
• Locations: 26 sites (Glendale, California and 25 other locations)
• Trial ID: NCT05168566 on ClinicalTrials.gov

What this trial studies

This Phase 2b multicenter, open-label study aims to assess the safety and efficacy of Sutetinib Maleate Capsule in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring specific non-resistant uncommon EGFR mutations. The study will involve patients who have had limited prior chemotherapy and will evaluate the drug's effectiveness in inhibiting cancer cell growth associated with these mutations. Participants will receive Sutetinib and be monitored for treatment outcomes and side effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic NSCLC and specific non-resistant uncommon EGFR mutations.

Not a fit: Patients who have previously received EGFR-TKI therapy or have other types of EGFR mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with specific EGFR mutations in lung cancer.

How similar studies have performed: Other studies have shown promise with similar EGFR-targeted therapies, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years old and above, male or female.
2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC patients with ≤ 1 prior line of chemotherapy.
3. 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..
4. At least one measurable lesion.
5. ECOG score of 0, 1, or 2.
6. A minimum life expectancy of \> 3 months.
7. Adequate bone marrow reserve, hepatic, renal and coagulation function.
8. Willingness of all subjects of childbearing potential to use acceptable methods of birth control.

Exclusion Criteria:

1. Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment.
2. 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.
3. 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.
4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment.
5. Any unresolved toxicities from prior therapy greater than Grade 1 at the time of screening except alopecia.
6. Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption.
7. Active central nervous system metastases
8. 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.
9. Any active infection which has not been controlled at screening.
10. Any serious cardiovascular disease.
11. History of other serious systemic disease not suitable for clinical trial.
12. 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).
13. Known alcohol or drug dependence.
14. Mental disorders or poor compliance.
15. Previously received solid organ transplantation or hematopoietic stem cell transplantation.
16. Females who are pregnant or breastfeeding.
17. Known hypersensitivity to the active ingredients or excipients of the investigational product.
18. Have any other primary malignant tumors within 3 years (except some low- risk cancers).

Where this trial is running

Glendale, California and 25 other locations

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

Study contacts

• Study coordinator: Xiaoyang Xia

Conditions: Non-small Cell Lung Cancer, Malignant tumor, EGFR mutation, lung cancer