New drug combo aims to fight resistant lung cancer
NCT ID NCT05009836
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This phase 3 trial tests whether adding savolitinib to the standard drug osimertinib helps people with a specific type of advanced lung cancer (EGFR-mutant, MET-positive non-small cell lung cancer). About 412 participants will receive either the combination or a placebo plus osimertinib. The study measures how long the cancer stays under control and checks for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- savolitinib combined with osimertinib
- What this could lead to
- If successful, this combination could become a new first-line treatment option for people with a specific type of lung cancer, potentially delaying disease progression.
- What could go wrong
- This is a phase 3 trial, but results are not yet available. The combination may not improve outcomes over standard care and could cause additional 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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 412 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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May 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. Fully aware of this study and voluntary to sign the informed consent form, and being willing and able to comply with the study procedure; 2. Age ≥ 18 3. In accordance with the Eighth Edition of TNM Staging of Lung Cancer by the International Association for the Study of Lung Cancer and American Joint Committee on Cancer, and patients with histologically or cytologically confirmed unresectable locally advanced (stage ⅢB/ⅢC), metastatic or recurrent (stage IV) NSCLC who are not suitable for radical concurrent chemoradiotherapy; 4. Carrying two common EGFR mutations clearly related with the sensitivity to EGFR-TKI (i.e., exon 19 deletion, and L858R) and c-MET overexpression 5. Having measurable lesions (in accordance with RECIST 1.1 criteria); 6. ECOG Performance Status score 0 or 1, or Karnofsky score ≥80; 7. Survival is expected to exceed 12 weeks; 8. No any previous systematic antitumor therapy for advanced/metastatic disease; 9. adequate bone marrow reserve or organ function 10. Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 6 weeks after discontinuation of the study drug , and agree not to donate ova (oocytes) for reproductive purposes during this period; 11. Male patients whose sexual partners are women of childbearing potential must use condoms during sexual intercourse during the study and within 6 months after discontinuation of study drug 12. Being able to take or swallow the drug orally. Exclusion Criteria: 1. Previous treatment with EGFR inhibitors or MET inhibitors; 2. Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years; 3. Antitumor therapy within 2 weeks prior to the start of study treatment, including hormone therapy, biotherapy, immunotherapy or the traditional Chinese medicine for antitumor indication; 4. Having received extensive radiotherapy (including radionuclide therapy, e.g., Sr-89) within 4 weeks prior to the start of study treatment or palliative local radiotherapy within one week prior to the start of study treatment, or the above adverse reactions of radiotherapy did not recover; 5. Having received a major surgery within 4 weeks prior to the start of study treatment or a minor surgery (except biopsy, and venous catheterization) within one week prior to the start of study treatment; 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. Uncontrollable hypertension despite the use of drugs, 12. Mean resting corrected QT interval (QTcF) or Any important abnormality in rhythm; 13. Patients whose known cancerous thrombus or deep vein thrombosis are stable for ≥2 weeks after receiving treatment with low molecular weight heparin (LMWH) or analogues with similar efficacy can be enrolled; 14. Any important abnormality in rhythm 15. Presence of meningeal metastasis, spinal cord compression or active brain metastasis prior to the start of study treatment. 16. Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib; 17. 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; 18. Having participated in other drug clinical trials and received the study drug within 3 weeks prior to the start of study treatment; 19. Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib; 20. Previous history of interstitial lung diseases, drug-induced interstitial lung diseases, radiation pneumonitis requiring glucocorticoid therapy and any active interstitial lung diseases; 21. Pregnant and lactating women; 22. Any other disease, metabolic abnormality, physical examination abnormality or laboratory examination abnormality, certain disease or state, based on which there is a reason to suspect that the subject is not suitable for the study drug, or one condition that will affect intepretaton of the study results or put the subject at high risk. 23. History of cirrhosis of any etiology and clinical stage; or other severe liver disease or chronic disease with severe liver involvement.
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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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Guangdong General Hospital
Guangzhou, China
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