Experimental drug combo targets Hard-to-Treat lung cancer

NCT ID NCT04922658

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jun 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

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

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

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095, China

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