Non-small Cell Lung Cancer
Conditions
Interventions
Experimental group1:denosumab
Experimental group2:PD-1 inhibitor
Sponsors
National Cancer Center / National Cancer Clinical Medicine Research Center / Cancer Hospital of Peking Union Medical College, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Cytologically or histologically confirmed stage IV NSCLC; 3. No progression by imaging assessment after 4-6 cycles of first-line PD-1 inhibitor combined with chemotherapy; 4. With or without bone metastases; 5. At least 1 measurable target lesion according to RECIST criteria (v1.1); 6. The presence of NGS-confirmed KRAS mutation without classical driver gene alterations (EGFR activating mutation, ALK rearrangement, ROS-1 translocation, BRAF mutation, etc.); 7. ECOG score 0-2 points; 8. Estimated life expectancy >= 12 weeks; 9. No previous malignant tumor within the previous 5 years, except for cervical carcinoma in situ or skin basal cell carcinoma or squamous cell carcinoma who have been fully treated; 10. Normal organ function confirmed by laboratory analysis within 7 days before enrollment; (1) Normal liver function: bilirubin =45 mL/min); (3) Hematological function: absolute number of neutrophils >=1.5x10^9/L and (or) platelets >=100x10^9/L, hemoglobin >=80g/L; 11. Women of childbearing age must use effective contraceptive methods and mechanical contraception during treatment and within 6 months after treatment. Men must use effective contraception during treatment and for 6 months after treatment ends; 12. Patients with asymptomatic brain metastases (regardless of treatment or not) or symptomatic brain metastases that have been adequately treated and controlled at the time of enrollment (without or with cortical therapy <=10 mg/day); 13. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Untreated and uncontrolled patients with symptomatic brain metastases; 2. Patients with meningeal metastases; 3. Contraindications for the use of PD-1 inhibitors: (1) Previous autoimmune disease, defined as a disease that required systemic treatment in the past (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy; (2) previous diffuse interstitial lung disease; (3) Systemic immunosuppressive therapy; defined as steroid drug therapy, with a dose greater than 10 mg/day of prednisone or an equivalent dose. For patients with mismatch repair-deficient high-grade gliomas, steroids should be used at a dose greater than 20 mg/day of prednisone or equivalent. 4. Contraindications for the use of denosumab: (1) The teeth are in poor condition and require immediate special treatment, such as oral surgery; (2) Previous or current symptoms of mandibular osteonecrosis/osteomyelitis; (3) Invasive dental interventions during the study period or before the study but not healed; (4) Patients known to be sensitive to any product administered during the study. 5. Concomitant use of bisphosphonates; 6. Hypocalcemia or uncorrected severe hypercalcemia; 7. pregnant or breastfeeding women; 8. Include drug abuse, medical, psychological or social conditions that make the patient unsuitable to participate in the trial or any condition that may interfere with the patient's participation in the study in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Safety; | — |
Countries
China
Contacts
Public ContactWang Yan
National Cancer Center / National Cancer Clinical Medicine Research Center / Cancer Hospital of Peking Union Medical College, Chinese Academy of Medical Sciences
Outcome results
None listed