Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases

NCT06702826 | Recruiting Phase 2

• 1 other identifier: 202410188
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Cadonilimab combined with stereotactic radiation therapy in the second-line treatment of brain metastases from non-small cell lung cancer (NSCLC). The main questions it aims to answer are:

• Does Cadonilimab combined with SRT in the second-line treatment of brain metastases provide better results?
• Is the toxicity of Cadonilimab combined with SRT manageable in second-line treatment of brain metastases? Researchers will compare evaluate the efficacy and safety of Cadonilimab combined with SRT as a second-line treatment for patients with advanced NSCLC：
• Receive Cadonilimab combined with SRT for brain lesions.
• Visit the hospital regularly once every 12 weeks for checkups and tests

Conditions

Non Small Cell Lung Cancer; Brain Metastases; Stereotactic Radiation; Immunotherapy

Keywords

non small cell lung cancer; brain metastases; SRS; immunotherapy

Outcome Measures

Primary Outcomes (1)

• iORR

  Intracranial objective response rate (iORR) was defined as the proportion of patients who achieved a prespecified reduction in tumor volume and maintained the minimum time requirement, including CR and PR cases.

  From date of enrollment until the date of first documented intracranial progression, assessed up to 2 years.

Secondary Outcomes (3)

• PFS

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

• iPFS

  From date of enrollment until the date of first documented intracranial progression or date of death from any cause, whichever came first, assessed up to 2 years

• OS

  From date of enrollment until the date of death from any cause, whichever came first, assessed up to 2 years

Study Arms (1)

Cadonilimab combined with SRS

EXPERIMENTAL

Eligible subjects were treated with stereotactic radiotherapy for brain metastases plus Cadonilimab followed by maintenance therapy with Cadonilimab alone

Drug: Cadonilimab combined with SRS

Interventions

Cadonilimab combined with SRS DRUG

Eligible subjects were treated with stereotactic radiotherapy for brain metastases plus Cadonilimab followed by maintenance therapy with Cadonilimab alone

Cadonilimab combined with SRS

Eligibility Criteria

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

You may qualify if:

• years old ≤ 75 years old; Both male and female;
• ECOG 0-1;
• Histologically or cytologically confirmed non-small cell lung cancer;
• Progression with brain metastasis after previous first-line anti-tumor therapy;
• Requirements for brain metastases: ① measurable brain metastases without radiotherapy; ②SRS/FSRT: the maximum tumor volume of brain metastases was less than 10cm3, the single diameter was less than 3cm, and the total volume of brain metastases involved was less than 15 cm3.
• Response to previous checkpoint inhibitor therapy on the initial response assessment;
• If a metastatic lesion of the head has been irradiated, the cumulative radiation dose does not exceed the tolerated dose to all structures.
• For patients with measurable CNS lesions, the longest diameter on MRI images is ≥10mm, which is suitable for repeated and accurate measurement.
• Subjects were evaluated for all extracranial disease sites (e.g., by computed tomography (CT) scan and bone scan or positron emission tomography (PET-CT) within 14 days before the first dose.
• Subjects had to have a baseline brain MRI scan within 14 days before the first dose of medication.
• Estimated survival time \> 12 weeks.
• Participants of childbearing age must agree to use effective contraception during the trial; In women of childbearing age, a serum or urine pregnancy test must be negative.
• Patients who are not lactating.
• Have definite and good organ functions:
• Provide informed consent voluntarily, and be willing and able to comply with the follow-up, treatment, laboratory testing, and other study requirements specified in the study schedule.

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible to participate in the study:
• Experienced grade 3-4 intracranial toxicity (pituitary or central nervous system toxicity);
• No measurable intracranial metastatic lesions without radiotherapy;
• Meningeal metastasis;
• If receiving chemotherapy or targeted therapy, the washout period should not exceed 3 weeks; if receiving brain metastasis resection, the washout period should not exceed 2 weeks;
• Have significant autoimmune diseases
• Prior treatment with a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor.
• Previous (within 5 years) or concurrent other malignant tumors
• History of anaphylaxis to any monoclonal antibody and/or study drug component.
• A history of or current noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoids.
• Serious infection within 4 weeks before the first dose.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Subjects required systemic treatment with corticosteroids (\>10mg prednisone equivalent per day) or other immunosuppressive drugs within 14 days before taking the study drug.
• Patients with clinically significant cardiovascular disease
• Enroll in another clinical study at the same time, unless it is an observational, noninterventional clinical study or a follow-up of an interventional study.

Sponsors & Collaborators

• Rongrong Zhou: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Spermine Synthase

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)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Central Study Contacts

Rongrong Zhou, MD, PHD

CONTACT

+8613875898127; zhourr@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Department of Oncology

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 25, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CN (1)