The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases. Methods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR/PR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR/PR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%. Wangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-80 lat
- •Zaawansowany rak płuca (stadium IV) potwierdzona biopsją lub cytologią
- •Przerzuty do kości wymagające napromieniania
- •Bez wcześniejszego leczenia systemowego (chemioterapia, immunoterapia lub terapia celowana)
- •Geny opornościowe (EGFR, ALK, ROS-1) ujemne u pacjentów z rakiem gruczołowym
- •Przynajmniej jeden mierzalny guz poza kośćmi
- •Ogólny stan zdrowia pozwalający na leczenie (wynik ECOG 0-1)
- •Spodziewana długość przeżycia powyżej 3 miesięcy
✗ Disqualifies
- •Drobnokomórkowy rak płuca lub mieszany typ z drobnokomórkowym
- •Pojedynczy guz możliwy do wyleczenia chirurgicznie lub napromienianiem
- •Aktywne przerzuty do mózgu
- •Poprzednia radioterapia lub niemożliwość napromieniania guza przeznaczonego do leczenia
- •Inne nowotwory w ciągu ostatnich 5 lat (poza rakiem skóry lub zmianami przedrakującymi)
- •Ciężkie uszkodzenie funkcji wątroby, nerek lub serca
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- July 23, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China
Trial contact
Zhengfei Zhu
Wangjun Yan
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/24/2026.
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