Tests sutetinib capsule in lung cancer with uncommon EGFR gene changes
Tests sutetinib capsules in adults with advanced non-small cell lung cancer and uncommon EGFR mutations.
Plain-language title generated from the registry record
Registry title: Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
Key facts
- Where
- Birtinya, Subiaco, and Sydney, AustraliaSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced or metastatic non-small cell lung cancer whose tumor has an uncommon EGFR mutation (L861Q, G719X and/or S768I). They have had at most 1 earlier line of chemotherapy.
- Age
- 18 years and older
- Sex
- Men and women can join.
- Disease stage
- Locally advanced or metastatic non-small cell lung cancer, confirmed by tissue or cell examination, with at least one measurable lesion. ECOG score of 0, 1 or 2 and life expectancy of more than 3 months.
- Earlier treatment
- At most 1 earlier line of chemotherapy. No earlier EGFR-TKI treatment.
- Biomarker or test result
- Tumor with a non-resistant uncommon EGFR mutation: one or more of L861Q, G719X and S768I (tumor tissue biopsy). No other EGFR sensitive mutations and/or oncogenes.
Main reasons for not taking part
- Earlier treatment with an EGFR-TKI
- Active central nervous system metastases
- Past or current interstitial lung disease or radiation pneumonitis needing hormone therapy
- Pregnant or breastfeeding women
- Earlier solid organ or stem cell transplant
Read by machine on 9 November 2026.
Where in Australia
- Sunshine Coast Hospital and Health ServiceBirtinya, AustraliaTaking people
- St. John of God Subiaco HospitalSubiaco, AustraliaTaking people
- Macquarie University HospitalSydney, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Teligene US
- Trial code
- NCT05168566
- Record updated
- 27 October 2026
- Original description
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)Read full original descriptionShow less
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 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)
Inclusion: 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: 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 (including Chinese patent medicine) 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; 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; 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; Previously received solid organ transplantation or hematopoietic stem cell transplantation; Known hypersensitivity to the active ingredients or excipients of the investigational product; Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption; 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; Mental disorders or poor compliance; Have any other primary malignant tumors within 3 years (except some low- risk cancers); Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment; Active central nervous system metastases; Females who are pregnant or breastfeeding.