Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC

NCT06350162 | Recruiting Phase 2 DMC

• 1 other identifier: ASTRUM-LC12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer .

Conditions

Extensive Stage Lung Small Cell Cancer

Outcome Measures

Primary Outcomes (1)

• 1-year Progression-free survival rate

  PFS rate after 1 year after randomization

  up to 1year

Secondary Outcomes (4)

• Progression-free survival (PFS)

  up to 12 months after last patient randomized

• Overall survival (OS)

  up to 22 months after last patient randomized

• Duration of response (DOR)

  up to approximately 24 months

• Disease control rate (DCR)

  up to approximately 24 months

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  From baseline up to approximately 24 months

Study Arms (2)

Serplulimab+Radiation Therapy

EXPERIMENTAL

Patients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-3 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

Drug: Serplulimab; Radiation: Chest Radiation

Serplulimab

ACTIVE COMPARATOR

Patients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

Drug: Serplulimab

Interventions

Serplulimab DRUG

4.5mg/kg,IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days.

Also known as: HLX10

Serplulimab; Serplulimab+Radiation Therapy

Chest Radiation RADIATION

30Gy-45Gy/QD/3Gy

Serplulimab+Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in clinical studies; fully understand, be informed about the study and have signed the informed consent form (ICF).
• Male or female aged ≥ 18 and ≤ 75 years, at the time of signing the ICF.
• Willingness to follow and ability to complete all trial procedures.
• Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
• No prior systemic therapy for ES-SCLC；at the end of the combination chemotherapy with serplulimab, the efficacy evaluation is CR, PR, or SD.
• At least one measurable lesion as assessed according to RECIST 1.1 , lesions that have received radiation therapy in the past are only considered measurable if they show clear progression.
• An ECOG PS score of 0 or 1.
• An expected survival ≥ 3 months.
• Normal major organ functions
• For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative human immunodeficiency virus (HIV) test at screening
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Positive hepatitis B surface antibody (HBsAb) test at screening, and positive hepatitis B virus core antibody (HBcAb), no HBV-DNA test is required; or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.

You may not qualify if:

• Complete response or tumor progression occurred during the combination of serplulimab and chemotherapy treatment.
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.Patients with CNS lesions treated and Asymptomatic are eligible to participate in this study if they meet all of the following criteria: Measurable lesions exist outside of CNS that meet the definition of RECISTv1.1; The patient has no history of Intracranial hemorrhage or intracerebral hemorrhage; The patient did not receive stereotactic radiotherapy within 7 days before the start of the study treatment, whole brain radiotherapy within 14 days before the start of the study treatment, or Neurosurgery resection within 28 days before the start of the study treatment; Patients do not need to continue to receive Corticosteroid treatment for CNS diseases. Allowing stable doses of anticonvulsant drugs for treatment; Transfer is limited to the cerebellum or supratentorial area (i.e. not transferred to the midbrain, pons, medulla oblongata, or spinal cord); There is no evidence to suggest progress between the completion of CNS local treatment and the initiation of study treatment; New Asymptomatic patients with central nervous system metastasis found during screening are eligible to participate in this study after receiving radiotherapy and/or surgery
• History of leptomeningeal disease.
• The total number of liver metastases was ≥3 or a single liver metastases was greater than 3cm
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN).
• Known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll.
• Have a history of Idiopathic pulmonary fibrosis, organized pneumonia (such as Bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or chest computed tomography (CT) at screening shows evidence of active pneumonia.
• Active or latent pulmonary tuberculosis.
• Serious cardiovascular disease (such as heart disease, myocardial infarction or cerebrovascular accident of New York Heart Association Grade II or above), unstable arrhythmia or unstable angina pectoris occurred within 3 months before the start of the study treatment.
• Major surgical procedures other than diagnosis have been performed within 4 weeks prior to the start of the study treatment, or significant surgical procedures are expected to be required during the study period.
• Malignant tumors other than small cell lung cancer (SCLC) occurred within 5 years before the start of the study treatment, but the cancer under study and malignant tumors with negligible risk of metastasis or death (such as the 5-year overall survival rate\>90%) were excluded, such as fully treated cervical Carcinoma in situ, non Melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I Uterine cancer.
• Severe infection occurred within 4 weeks before the start of study treatment, including but not limited to hospitalization due to infection, Bloodstream infections, severe pneumonia or any active infection that may affect the safety of patients.
• Previously received allogeneic stem cell or solid organ transplantation.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, China

RECRUITING

Study Officials

• Yun Fan, PHD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Fan, PHD

CONTACT

0571-88122092; fanyun@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Chest Oncology Department

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 5, 2024
• Study Start: October 18, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)