NSCLCPhase 2NCT06414915

Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

A Phase 2 study testing Surufatinib and Tislelizumab in people with NSCLC, run by National Cancer Center, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NSCLC
What is being tested?: Surufatinib and Tislelizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: No sites listed yet
Study dates: 1 Jun 2024to 1 Jun 2027
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn));
Have at least one measurable lesion according to RECIST v1.1;
ECOG performance status: 0-1;
Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy;
Urine protein < ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
Expected survival time > 3 months;

Who cannot join

Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma);
Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody;
Have uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
Patients with active ulcer, intestinal perforation and intestinal obstruction;
With active bleeding or bleeding tendency;
Severe history of cardiovascular and cerebrovascular diseases;
Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Puyuan Xing, Doctorate contact

+86-10-87787421

xingpuyuan@cicams.ac.cn

About this study

Official title: A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation

Read the detailed description

This is a single-arm, open, single-center, prospective and exploratory clinical study. We planned to enroll 29 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.

Conditions: NSCLC
Being tested: Surufatinib, Tislelizumab
Keywords: NSCLC, neuroendocrine differentiation, Surufatinib, Tislelizumab

What participants receive

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

SurufatinibDrug
250 mg, po, qd, q3w
TislelizumabDrug
200mg, iv, q3w

Study groups in NCT06414915
Study group	Role	What they receive
Surufatinib + tislelizumab	Experimental	Not described Receives: Drug: Surufatinib; Drug: Tislelizumab

What is being measured

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

Progression-Free Survival (PFS)
time from first-dose to the first documented disease progression or death
Measured: approximately 1 years

Secondary outcomes (2)

Objective response rate (ORR)
the proportion of patients with complete response or partial response, using RESIST v1.1
Measured: approximately 1 years
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1
Measured: approximately 1 years

Timeline

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

1 Jun 20241 Jun 2027

First posted16 May 2024
Study start1 Jun 2024 (estimated)
Primary completion1 Jun 2026 (estimated)
Study completion1 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLCStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06414915
Sponsor's protocol ID: HMPL-012-SPRING-NEN110
Status last verified: May 2024
First submitted: 10 May 2024
Last updated: 16 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation
ClinicalTrials.gov ID: NCT06414915
Acronym / sponsor ID: HMPL-012-SPRING-NEN110
Conditions: NSCLC
Keywords: NSCLC, neuroendocrine differentiation, Surufatinib, Tislelizumab
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 29 participants (estimated)
Lead sponsor: National Cancer Center, ChinaUniversity, hospital or other
Study start: 1 Jun 2024 (estimated)
Primary completion: 1 Jun 2026 (estimated)
Study completion: 1 Jun 2027 (estimated)
First posted: 16 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Surufatinib + tislelizumab	Experimental	Drug: Surufatinib, Drug: Tislelizumab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn));
Have at least one measurable lesion according to RECIST v1.1;
ECOG performance status: 0-1;
Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy;
Urine protein < ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;

Key exclusion criteria (7 listed)

Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma);
Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody;
Have uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
Patients with active ulcer, intestinal perforation and intestinal obstruction;
With active bleeding or bleeding tendency;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Surufatinib250 mg, po, qd, q3w	Drug	Surufatinib + tislelizumab
Tislelizumab200mg, iv, q3w	Drug	Surufatinib + tislelizumab

Primary outcome

Progression-Free Survival (PFS)
Time frame: approximately 1 years
time from first-dose to the first documented disease progression or death

2 secondary outcomes

Objective response rate (ORR)
Time frame: approximately 1 years
Disease Control Rate (DCR)
Time frame: approximately 1 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Puyuan Xing, Doctorate contact

+86-10-87787421

xingpuyuan@cicams.ac.cn

Puyuan Xing, Doctorate principal investigator

Department of Medical Oncology, National Cancer Center, China

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib and Tislelizumab in people with NSCLC, run by National Cancer Center, 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Puyuan Xing, Doctorate (+86-10-87787421, xingpuyuan@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: approximately 1 years). 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 NCT06414915.

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 16 May 2024.