Non-small Cell Lung Cancer Stage IIPhase 2/3SUPER BRAINNCT05807893

Study to Evaluate the Safety and Efficacy of Serplulimab Plus Bevacizumab and Chemotherapy in NSCLC Patients With Brain Metastases

A Phase 2/3 study testing Serplulimab combined with bevacizumab and first-line chemotherapy in people with Non-small Cell Lung Cancer Stage II and Bevacizumab, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A multicenter, single-arm, open study to evaluate the safety and efficacy of Serplulimab in combination with bevacizumab and first-line chemotherapy in driver negative non-squamous NSCLC patients with brain metastases Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Non-small Cell Lung Cancer Stage II, Bevacizumab, Immunotherapy
What is being tested?: Serplulimab combined with bevacizumab and first-line chemotherapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 14 May 2023to 15 May 2024
Phase: Phase 2/3
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects with stage IV non-squamous non-small cell lung cancer (nsqNSCLC) with brain metastases confirmed by histopathology or cytology;
The patient should provide a gene test report within 3 months, and the gene report showed negative driver gene, that is, no EFGR sensitive gene mutation, no ALK or ROS1 gene fusion;
MRI confirmed brain parenchymal metastasis with ≥3 brain lesions; Or have 1-2 brain lesions but not suitable for local treatment or refuse local treatment patients. There must be at least 1 measurable lesion with a diameter ≥5mm in the brain; Patients with local meningeal metastases were allowed, but patients with extensive meningeal metastases were not included;
For asymptomatic BMS or BMS whose intracranial hypertension symptoms were controlled after dehydration treatment, medication could be continued at the time of enrollment or during the study period to keep symptoms stable;
There was at least one measurable target lesion as assessed by RECIST v1.1 within 4 weeks prior to initial medication;
The patient agrees to provide the genetic test results within 3 months; if not, the patient shall provide the tumor tissue that meets the requirements for genetic test;
ECOG PS score is 0-1; Good functioning of vital organs

Who cannot join

A known history of severe allergy to any monoclonal antibody (NCI-CTCAE 5.0 grade greater than 3); Or known hypersensitivity to carboplatin/pemetrexed components;
Any active infection requiring systemic anti-infective therapy occurs within 14 days prior to initial administration;
A history of myocardial infarction and poorly controlled arrhythmias (including QTc interval ≥450 ms in men and 470 ms in women) within 6 months prior to initial administration (QTc interval calculated by Fridericia formula); Or left ventricular ejection fraction according to NYHA standard for Grade III-IV cardiac insufficiency or color Doppler ultrasound \< 50%;
The subjects had ≥ grade 2 CTCAE peripheral neuropathy;
The subject has uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionic calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN);
Subjects with prior or screening history of interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function, which the investigators judged might interfere with the detection and management of suspected drug-related pulmonary toxicity;

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Hepatitis B patients [hepatitis B surface antigen (HBsAg) positive and detection of HBV-DNA suggests viral replication]; Or hepatitis C patients [hepatitis C virus (HCV) antibody positive and HCV-RNA test indicates viral replication]; Or syphilis screening positive (specific antibody test positive, non-specific antibody test negative and combined with clinical diagnosis confirmed as non-active infection); Or a known human immunodeficiency virus (HIV) positive history or HIV screening positive;
Subjects have known active or suspected autoimmune diseases. Subjects in stable state who did not require systemic immunosuppressive therapy were admitted;
Other active malignancies within 5 years or at the same time. Localized tumors that have been cured for more than 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ, can be included in the group.
Those who received live or attenuated vaccines within 28 days prior to the first dose or have plans to receive such vaccines during the study period; But inactivated virus vaccines for seasonal influenza are allowed.

Trial locations and contacts

1 site in 1 country.

China1 site

Likun Chen
Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Multicenter, Single-arm, Open Study to Evaluate the Safety and Efficacy of Serplulimab in Combination With Bevacizumab and First-line Chemotherapy in Driver Negative Non-squamous NSCLC Patients With Brain Metastases

Read the detailed description

This is a multicenter, single-arm, open study. Thirty patients with stage IV nsqNSCLC with BMs confirmed by histopathology or cytology and reported negative driver genes within three months were enrolled. To evaluate the safety, tolerability and efficacy of Serplulimab combined with bevacizumab and first-line chemotherapy in driver negative nsqNSCLC subjects with brain metastases.

Qualified subjects were selected and entered into the study in sequence. The trial was divided into combination chemotherapy period (C1-C4/C6) and maintenance treatment period (C5/C7-C32). In combination chemotherapy period, all subjects were treated with Serplulimab combined with bevacizumab and chemotherapy agents after entering the study, and in maintenance treatment period, Serplulimab combined with bevacizumab and pemetrexed. The efficacy was evaluated every 3 weeks (Q3W), every 2 cycles in combination chemotherapy and every 3 cycles in maintenance treatment. All subjects received treatment until subjects withdrew their informed consent, disease progression, intolerable toxicity, investigator judgment that medication must be discontinued, loss of follow-up, death, or 2 years of use of Serplulimab, whichever occurred first; At the end of treatment, patients were followed up for survival until death.

Conditions: Non-small Cell Lung Cancer Stage II, Bevacizumab, Immunotherapy, Brain Metastases
Being tested: Serplulimab combined with bevacizumab and first-line chemotherapy
Keywords: bevacizumab, Serplulimab, efficacy, non-small cell lung cancer, brain metastases
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

What participants receive

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

Serplulimab combined with bevacizumab and first-line chemotherapyDrug
Serplulimab combined with bevacizumab and first-line chemotherapy

Study groups in NCT05807893
Study group	Role	What they receive
Serplulimab combined with bevacizumab and first-line chemotherapy	Experimental	Serplulimab combined with bevacizumab and first-line chemotherapy Receives: Drug: Serplulimab combined with bevacizumab and first-line chemotherapy

What is being measured

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

iPFS
The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first,
Measured: The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first, assessed up to 60 months

Secondary outcomes (3)

PFS
The time from receipt of study treatment to PD or to death due to any cause,,whichever came first,
Measured: The time from receipt of study treatment to PD or to death due to any cause,whichever came first, assessed up to 60 months.
OS
The time interval between enrollment and death from any cause
Measured: The time interval between enrollment and death from any cause,,whichever came first, assessed up to 60 months.
iORR
The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment
Measured: The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment, through study completion, an average of 2 year.

Timeline

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

14 May 202315 May 2024

First posted11 Apr 2023
Study start14 May 2023
Primary completion22 Mar 2024
Study completion15 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung Cancer Stage IIStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05807893
Sponsor's protocol ID: HLX10IIT27
Acronym: SUPER BRAIN
Status last verified: Nov 2024
First submitted: 13 Mar 2023
Last updated: 13 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology

All Non-small Cell Lung Cancer Stage II trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single-arm, Open Study to Evaluate the Safety and Efficacy of Serplulimab in Combination With Bevacizumab and First-line Chemotherapy in Driver Negative Non-squamous NSCLC Patients With Brain Metastases
ClinicalTrials.gov ID: NCT05807893
Acronym / sponsor ID: SUPER BRAIN / HLX10IIT27
Conditions: Non-small Cell Lung Cancer Stage II, Bevacizumab, Immunotherapy, Brain Metastases
Keywords: bevacizumab, Serplulimab, efficacy, non-small cell lung cancer, brain metastases
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 14 May 2023 (actual)
Primary completion: 22 Mar 2024 (actual)
Study completion: 15 May 2024 (actual)
First posted: 11 Apr 2023 (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
Serplulimab combined with bevacizumab and first-line chemotherapy	Experimental	Drug: Serplulimab combined with bevacizumab and first-line chemotherapySerplulimab combined with bevacizumab and first-line chemotherapy

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects with stage IV non-squamous non-small cell lung cancer (nsqNSCLC) with brain metastases confirmed by histopathology or cytology;
The patient should provide a gene test report within 3 months, and the gene report showed negative driver gene, that is, no EFGR sensitive gene mutation, no ALK or ROS1 gene fusion;
MRI confirmed brain parenchymal metastasis with ≥3 brain lesions; Or have 1-2 brain lesions but not suitable for local treatment or refuse local treatment patients. There must be at least 1 measurable lesion with a diameter ≥5mm in the brain; Patients with local meningeal metastases were allowed, but patients with extensive meningeal metastases were not included;
For asymptomatic BMS or BMS whose intracranial hypertension symptoms were controlled after dehydration treatment, medication could be continued at the time of enrollment or during the study period to keep symptoms stable;
There was at least one measurable target lesion as assessed by RECIST v1.1 within 4 weeks prior to initial medication;

Key exclusion criteria (10 listed)

A known history of severe allergy to any monoclonal antibody (NCI-CTCAE 5.0 grade greater than 3); Or known hypersensitivity to carboplatin/pemetrexed components;
Any active infection requiring systemic anti-infective therapy occurs within 14 days prior to initial administration;
A history of myocardial infarction and poorly controlled arrhythmias (including QTc interval ≥450 ms in men and 470 ms in women) within 6 months prior to initial administration (QTc interval calculated by Fridericia formula); Or left ventricular ejection fraction according to NYHA standard for Grade III-IV cardiac insufficiency or color Doppler ultrasound \< 50%;
The subjects had ≥ grade 2 CTCAE peripheral neuropathy;
The subject has uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionic calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN);

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
Serplulimab combined with bevacizumab and first-line chemotherapySerplulimab combined with bevacizumab and first-line chemotherapy	Drug	Serplulimab combined with bevacizumab and first-line chemotherapy

Primary outcome

iPFS
Time frame: The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first, assessed up to 60 months
The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first,

3 secondary outcomes

PFS
Time frame: The time from receipt of study treatment to PD or to death due to any cause,whichever came first, assessed up to 60 months.
OS
Time frame: The time interval between enrollment and death from any cause,,whichever came first, assessed up to 60 months.
iORR
Time frame: The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment, through study completion, an average of 2 year.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
Individual participant dataSharing planned: No

Related trials for Non-small Cell Lung Cancer Stage II

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 13 Nov 2024. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

iPFS (time frame: The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first, assessed up to 60 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 NCT05807893.

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 13 Nov 2024.