New pill shows promise for rare lung cancer mutations
NCT ID NCT05168566
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called sutetinib in people with advanced non-small cell lung cancer that has certain uncommon EGFR mutations (L861Q, G719X, or S768I). About 99 participants will take the drug by mouth to see if it shrinks tumors and how safe it is. The goal is to find a better treatment option for this specific group of patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sutetinib maleate capsule
- What this could lead to
- If successful, this could provide a new targeted treatment option for people with non-small cell lung cancer that has certain uncommon EGFR mutations.
- What could go wrong
- This is an early-phase (2b) study with only 99 participants, so results may not apply broadly. The drug may not work as hoped or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baptist Health
WITHDRAWNLouisville, Kentucky, 40223, United States
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Beijing Cancer Hospital
ACTIVE_NOT_RECRUITINGBeijing, Beijing Municipality, 100142, China
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Beijing Chest Hospital
ACTIVE_NOT_RECRUITINGBeijing, Beijing Municipality, 101125, China
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Cancer Hospital Chinese Academy of Medical Sciences
ACTIVE_NOT_RECRUITINGBeijing, Beijing Municipality, 100021, China
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FirstHealth Cancer Center
RECRUITINGPinehurst, North Carolina, 28374, United States
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Harbin Medical University Cancer Hospital
ACTIVE_NOT_RECRUITINGHarbin, Heilongjiang, 150086, China
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Henan Cancer Hospital
ACTIVE_NOT_RECRUITINGZhengzhou, Henan, 450003, China
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Hunan Cancer Hospital
ACTIVE_NOT_RECRUITINGChangsha, Hunan, 410006, China
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Jiangsu Province Hospital
ACTIVE_NOT_RECRUITINGNanjing, Jiangsu, 210029, China
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Jilin Cancer Hospital
ACTIVE_NOT_RECRUITINGChangchun, Jilin, 130012, China
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Linyi Cancer Hospital
ACTIVE_NOT_RECRUITINGLinyi, Shangdong, 276001, China
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OPN Healthcare, Inc.
RECRUITINGGlendale, California, 91203, United States
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Peking Union Medical College Hospital
ACTIVE_NOT_RECRUITINGBeijing, Beijing Municipality, 100730, China
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Shanghai Chest Hospital
ACTIVE_NOT_RECRUITINGShanghai, Shanghai Municipality, 200052, China
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Shanghai Pulmonary Hospital
ACTIVE_NOT_RECRUITINGShanghai, Shanghai Municipality, 200437, China
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Sichuan Cancer Hospital
ACTIVE_NOT_RECRUITINGChengdu, Sichuan, 610044, China
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The Affiliated Cancer Hospital of Chongqin University
ACTIVE_NOT_RECRUITINGChongqing, Chongqing Municipality, 400044, China
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The First Affiliated Hospital of Bengbu Medical College
ACTIVE_NOT_RECRUITINGBengbu, Anhui, 230000, China
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The First Affiliated Hospital of China Medical University
ACTIVE_NOT_RECRUITINGShengyang, Liaoning, 830000, China
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The First Affiliated Hospital of Guangzhou Medical University
ACTIVE_NOT_RECRUITINGGuangzhou, Guangdong, 510230, China
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The First Affiliated Hospital of Zhengzhou University
ACTIVE_NOT_RECRUITINGZhengzhou, Henan, 450052, China
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University Cancer & Blood Center
RECRUITINGAthens, Georgia, 30607, United States
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University of Maryland Medical Center
RECRUITINGBaltimore, Maryland, 21201, United States
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University of Texas MD Anderson Cancer Center
ACTIVE_NOT_RECRUITINGHouston, Texas, 77030, United States
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Wuhan Union Hospital of China
ACTIVE_NOT_RECRUITINGWuhan, Hubei, 430000, China
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Zhejiang Cancer Hospital
ACTIVE_NOT_RECRUITINGHangzhou, Zhejiang, 310022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?