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

Efficacy and Safety of Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases From Non-small Cell Lung Cancer (NSCLC) : a Single-arm, Open-label, Phase II Clinical Trial

Cadonilimab Combined With Stereotactic Radiotherapy as Second-line Treatment for Brain Metastases (NCT06702826) is a Phase 2 interventional studying Non Small Cell Lung Cancer and Brain Metastases, sponsored by Rongrong Zhou. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Non Small Cell Lung Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 18 years old ≤ 75 years old; Both male and female; 2. ECOG 0-1; 3. diagnosed by tissue sample (biopsy-confirmed) non-small cell lung cancer; 4. Progression with brain metastasis after previous first-line anti-tumor therapy; 5. 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. 6. Response to previous checkpoint inhibitor therapy on the initial response assessment; 7. If a metastatic lesion of the head has been irradiated, the cumulative radiation dose does not exceed the tolerated dose to all structures. 8. For patients with measurable CNS lesions, the longest diameter on MRI images is ≥10mm, which is suitable for repeated and accurate measurement. 9. 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. 10. Subjects had to have a baseline brain MRI scan within 14 days before the first dose of medication. 11. Estimated survival time \> 12 weeks. 12. 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. 13. Patients who are not lactating. 14. Have definite and good organ functions: 15. Provide willing to sign a consent form voluntarily, and be willing and able to comply with the follow-up, treatment, laboratory testing, and other study requirements specified in the study schedule. Who Should NOT Join This Trial: Subjects who meet any of the following criteria are not eligible to participate in the study: 1. Experienced grade 3-4 intracranial toxicity (pituitary or central nervous system toxicity); 2. No measurable intracranial metastatic lesions without radiotherapy; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. 18 years old ≤ 75 years old; Both male and female; 2. ECOG 0-1; 3. Histologically or cytologically confirmed non-small cell lung cancer; 4. Progression with brain metastasis after previous first-line anti-tumor therapy; 5. 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. 6. Response to previous checkpoint inhibitor therapy on the initial response assessment; 7. If a metastatic lesion of the head has been irradiated, the cumulative radiation dose does not exceed the tolerated dose to all structures. 8. For patients with measurable CNS lesions, the longest diameter on MRI images is ≥10mm, which is suitable for repeated and accurate measurement. 9. 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. 10. Subjects had to have a baseline brain MRI scan within 14 days before the first dose of medication. 11. Estimated survival time \> 12 weeks. 12. 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. 13. Patients who are not lactating. 14. Have definite and good organ functions: 15. 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. Exclusion Criteria: Subjects who meet any of the following criteria are not eligible to participate in the study: 1. Experienced grade 3-4 intracranial toxicity (pituitary or central nervous system toxicity); 2. No measurable intracranial metastatic lesions without radiotherapy; 3. Meningeal metastasis; 4. 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; 5. Have significant autoimmune diseases 6. Prior treatment with a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor. 7. Previous (within 5 years) or concurrent other malignant tumors 8. History of anaphylaxis to any monoclonal antibody and/or study drug component. 9. A history of or current noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoids. 10. Serious infection within 4 weeks before the first dose. 11. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 12. Subjects required systemic treatment with corticosteroids (\>10mg prednisone equivalent per day) or other immunosuppressive drugs within 14 days before taking the study drug. 13. Patients with clinically significant cardiovascular disease 14. 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. 15. Received live vaccine within 30 days before the first dose, or planned to receive live vaccine during the study. 16. Known history of mental illness, substance abuse, alcohol or drug abuse. 17. Pregnant or lactating women. 18. The presence of any past or current medical conditions, treatments, or laboratory abnormalities may confound the results of the study, interfere with the full participation of the subject in the study, or may not be in the best interest of the subject to participate in the study.

Treatments Being Tested

DRUG

Cadonilimab combined with SRS

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Xiangya Hospital, Central South University

Changsha, Hunan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06702826), the sponsor (Rongrong Zhou), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06702826 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06702826?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06702826?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06702826. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06702826. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.