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

November 10, 2024 updated by: Li-kun Chen, Sun Yat-sen University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Likun Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serplulimab combined with bevacizumab and first-line chemotherapy
Drug: Serplulimab combined with bevacizumab and first-line chemotherapy
Serplulimab combined with bevacizumab and first-line chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The time from receipt of study treatment to PD or to death due to any cause,,whichever came first,
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.
The time interval between enrollment and death from any cause
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.
The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2023

Primary Completion (Actual)

March 22, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX10IIT27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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