Experimental drug combo targets Hard-to-Treat lung cancer
NCT ID NCT04922658
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This phase II trial tests the drug surufatinib, either alone or combined with the chemotherapy vinorelbine, in people with advanced non-small cell lung cancer who have already tried at least two prior treatments. The goal is to see if these treatments can slow tumor growth or shrink tumors. Participants take the drugs by mouth daily, and the study measures how long they live without the cancer getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surufatinib, an oral drug that blocks blood vessel growth to tumors, sometimes combined with vinorelbine, a chemotherapy drug
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced lung cancer who have run out of standard therapies.
- What could go wrong
- This is a small, early-phase study without a comparison group, so results may not confirm real benefit. Side effects from the drug combination could be significant.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
76 people
The number who actually took part.
- Started
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Jun 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 80 years
- Sex
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Anyone
- Healthy volunteers
-
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. Provision of written Informed Consent Form (ICF) prior to any study specific procedures 2. Age ≥ 18 years, ≤80 years 3. Histologically or cytologically confirmed advanced NSCLC 4. At least two or more systemic therapies prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities 5. ECOG 0-2 6. Patients must have measurable lesions 7. Expected overall survival ≥6 months 8. AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN),Serum bilirubin ≤ 1.5 x ULN,creatinine\<ULN 9. Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN 10. Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment Exclusion Criteria: 1. Patients have received Surufatinib treatment 2. Patients with small cell lung cancer (including mixed small cell lung cancer and non-small cell lung cancer) 3. EGFR mutation /ALK rearrangement positive but not using relevant targeted drugs 4. Central squamous cell carcinoma with cavity or non-small cell lung cancer with hemoptysis (\> 50 ml / D) 5. Have received other systemic anti-tumor therapies within 2 weeks before recruited(eg.chemotherapy or radiotherapy, immunotherapy, biological or hormonal therapy, or any VEGFR inhibitor treatment) 6. Participated in the clinical trials of other drugs that have not been approved or marketed in China and received the corresponding experimental drug treatment within 2 weeks before enrollment 7. systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs 8. Clinically significant electrolyte abnormality 9. Proteinuria ≥ 2+ (1.0g/24hr) 10. Patients have untreated central nervous system metastasis 11. Received any operation or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment 12. Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE v5.0) Grade of 0 or 1, except for alopecia and oxaliplatin induced neurotoxicity ≤ 2 , and the previous surgery did not recover completely 13. Dysphagia or known malabsorption of drugs 14. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI 15. Have evidence or history of bleeding tendency within 2 months after enrollment, the researcher assessed that moderate or severe bleeding tendency was not suitable for enrollment 16. Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ); 17. Pregnant or lactating women 18. Allergic to Surufatinib/Vinorelbine 19. History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation 20. Patients with acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before admission; Or a history of arterial thrombosis or deep venous thrombosis 21. There are concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect the completion of the study, or any laboratory abnormalities that are not suitable for participating in the clinical trial according to the judgment of the researcher 22. Serious psychological or mental disorders that may affect the compliance 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.
Contacts and locations
Locations
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Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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