New pill combo shows promise against resistant lung cancer
NCT ID NCT05015608
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether combining two targeted drugs, savolitinib and osimertinib, works better than standard chemotherapy for people with advanced non-small cell lung cancer that has a specific genetic change (MET amplification) and has stopped responding to initial treatment. The trial enrolled 216 adults and measured how long the cancer stayed under control. The goal is to find a more effective, less toxic option for these patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Savolitinib and Osimertinib (oral drugs)
- What this could lead to
- If successful, this combination could offer a new targeted treatment option for people with a specific type of lung cancer that has stopped responding to initial therapy.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet widely known. The combination may not prove more effective than standard chemotherapy and could have side effects like nausea, fatigue, or liver issues.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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216 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Aug 2025
- 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 to 75 years
- 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. Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure; 2. Age ≥ 18 and ≤75 years; 3. In accordance with the 8th Edition of TNM staging for lung cancers by International Association for the Study of Lung Cancer and American Joint Committee on Cancer, patients with histologically or cytologically confirmed unresectable and non-suitable for radical concurrent chemoradiotherapy, locally advanced or metastatic (stage IIIB, IIIC or IV) NSCLC; 4. EGFR sensitive mutations prior to the first-line EGFR-TKI therapy; 5. Radiologically documented disease progression after the first-line EGFR-TKI; 6. MET amplification after disease progression following the first-line therapy; 7. Having measurable lesions (in accordance with RECIST 1. 1 criteria); 8. United States Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1; 9. Expected survival \>12 weeks; 10. Adequate bone marrow reserve or organ function 11. Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 4 weeks after discontinuation of the study drug; 12. Male subjects should be willing to agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. ; 13. Being able to take or swallow the drug orally. Exclusion Criteria: 1. Patients with positive T790M mutations; 2. Previous treatment for c-MET; 3. Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years.; 4. Previous use of systematic antitumor therapy other than EGFR-TKI for advanced NSCLC; 5. Currently having received antiangiogenic therapy or traditional Chinese medicine with antitumor indication、extensive radiotherapy 、palliative local radiotherapy, a major surgery,or participated in other drug clinical trials and received corresponding tudy drug etc; 6. Currently receiving the potent CYP3A4 inducers or potent CYP1A2 inhibitors within two weeks prior to the start of study treatment; 7. Having not been sufficiently recovered from the toxicity and/or complication resulting from any interventional measure prior to the start of treatment; 8. Clinically significant active infection, including but not limited to tuberculosis, human immunodeficiency virus (HIV) infection (positive HIV1/2 antibody); 9. Active hepatitis B, or active hepatitis C; 10. Acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack; 11. Known cancerous thrombus or deep vein thrombosis or uncontrollable hypertension despite the use of drugs; 12. Mean resting corrected QT interval (QTcF) or Any important abnormality in rhythm; 13. Presence of meningeal metastases, spinal cord compression or active brain metastases prior to the start of study treatment; 14. Active gastrointestinal disease or other conditions significantly affecting the absorption, distribution, metabolism or excretion of oral study drug; 15. Lack of compliance with participation in this clinical study or inability to comply with the limitations and requirements of the study, as judged by investigators; 16. Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib; 17. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis and any active interstitial lung disease; 18. Pregnant or breastfeeding women;
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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.
Contacts and locations
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 210000, China
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Other studies related to the condition(s) this trial covers.
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