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Advanced Non-Small Cell Lung CancerPhase 2NCT04922658

Surufatinib or Surufatinib Combined With Vinorelbine for Non-Small Cell Lung Cancer

A Phase 2 study testing Surufatinib and Surufatinib Plus Vinorelbine in people with Advanced Non-Small Cell Lung Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A phase II study to assess the efficacy and safety of Surufatinib or Surufatinib combined with Vinorelbine as third-line and posterior line treatment in patients with NSCLC Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
Surufatinib and Surufatinib Plus Vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteChina
Study dates
3 Jun 2020to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of written Informed Consent Form (ICF) prior to any study specific procedures
  • Age ≥ 18 years, ≤80 years
  • Histologically or cytologically confirmed advanced NSCLC
  • At least two or more systemic therapies prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities
  • ECOG 0-2
  • Patients must have measurable lesions
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  • Expected overall survival ≥6 months
  • AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN
  • Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
  • Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment

Who cannot join

  • Patients have received Surufatinib treatment
  • Patients with small cell lung cancer (including mixed small cell lung cancer and non-small cell lung cancer)
  • EGFR mutation /ALK rearrangement positive but not using relevant targeted drugs
  • Central squamous cell carcinoma with cavity or non-small cell lung cancer with hemoptysis (> 50 ml / D)
  • 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)
  • 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
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  • systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs
  • Clinically significant electrolyte abnormality
  • Proteinuria ≥ 2+ (1.0g/24hr)
  • Patients have untreated central nervous system metastasis
  • Received any operation or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment
  • 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
  • Dysphagia or known malabsorption of drugs
  • Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI
  • 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
  • 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);
  • Pregnant or lactating women
  • Allergic to Surufatinib/Vinorelbine
  • History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation
  • 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
  • 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
  • Serious psychological or mental disorders that may affect the compliance study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

Other trials in China

About this study

Official title: A Phase II, Single-arm, Two-cohorts, Open-label, Single Center Study of Surufatinib or Surufatinib Combined With Vinorelbine as Third-line and Posterior Line Treatment in Patients With Non-Small Cell Lung Cancer

A phase II study to assess the efficacy and safety of Surufatinib or Surufatinib combined with Vinorelbine as third-line and posterior line treatment in patients with NSCLC

Being tested
Surufatinib, Surufatinib Plus Vinorelbine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurufatinibDrug

    Surufatinib,300mg, qd, po, 21 days for a cycle; continuous administration until PD, death or intolerable toxicity.

  • Surufatinib Plus VinorelbineDrug

    Surufatinib, 250mg, qd, po; Plus Vinorelbine, 20 mg, every 2 days; 21days for a cycle; continuous administration until PD, death or intolerable toxicity.

Study groups in NCT04922658
Study groupRoleWhat they receive
SurufatinibExperimentalNot described
Receives: Drug: Surufatinib
Surufatinib plus VinorelbineExperimentalNot described
Receives: Drug: Surufatinib Plus Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    To assess the efficacy of Surufatinib or Surufatinib Combined With Vinorelbine for NSCLC , patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: up to 12 months

Secondary outcomes (3)

  1. Objective response rate (ORR)

    CR + PR rate according to the RECIST version 1.1 guidelines.

    Measured: up to 12 months

  2. Disease control rate (DCR)

    CR + PR + SD rate according to the RECIST version 1.1 guidelines.

    Measured: up to 12 months

  3. Overall survival (OS)

    The time interval between the start date of study drug and the date of death (any cause)

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start3 Jun 2020
  3. Primary completion1 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04922658
Sponsor's protocol ID
HMPL-012-SPRING-L106
Status last verified
Jul 2026
First submitted
6 Jun 2021
Last updated
15 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib and Surufatinib Plus Vinorelbine in people with Advanced Non-Small Cell Lung Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04922658.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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