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

NCT05807893 | Completed Phase 2

• 1 other identifier: HLX10IIT27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-small Cell Lung Cancer Stage II; Bevacizumab; Immunotherapy; Brain Metastases

Keywords

bevacizumab; Serplulimab; efficacy; non-small cell lung cancer; brain metastases

Outcome Measures

Primary Outcomes (1)

• iPFS

  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 Outcomes (3)

• PFS

  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,,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, through study completion, an average of 2 year.

Study Arms (1)

Serplulimab combined with bevacizumab and first-line chemotherapy

EXPERIMENTAL

Serplulimab combined with bevacizumab and first-line chemotherapy

Drug: Serplulimab combined with bevacizumab and first-line chemotherapy

Interventions

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Likun Chen

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 11, 2023
• Study Start: May 14, 2023
• Primary Completion: March 22, 2024
• Study Completion: May 15, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)