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Tests treatment safety and results for NSCLC
Official title 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
ClinicalTrials.gov ID: NCT06738160
What this study is testing
What is Narlumosbart?
Narlumosbart is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for nsclc.
Also referred to as chemotherapy, Stereotactic Body Radiation Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Signed written informed consent prior to the implementation of any trial-related procedures;
- Age ≥ 18 years old and ≤ 80 years old;
- Histologically or cytologically confirmed stage IV NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on...
- Histologically confirmed bone metastasis, which is assessed by the investigator to require local radiotherapy treatment;
- Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);
You likely can't join if
- The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
- The lesion is an isolated lesion and can be treated radically;
- Patients who need surgical treatment after the evaluation of the study are not allowed to enroll;
- The radiotherapy lesion to be treated has been treated with radiotherapy or the lesion to be treated cannot be treated with radiotherapy after...
- Presence of active brain metastases;
- Diagnosis of other malignant diseases other than NSCLC within 5 years before the first dose (excluding radically cured basal cell carcinoma of the...
See the full eligibility criteria
- Signed written informed consent prior to the implementation of any trial-related procedures;
- Age ≥ 18 years old and ≤ 80 years old;
- Histologically or cytologically confirmed stage IV NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Cancer Classification 9th Edition TNM Lung Cancer Staging);
- Histologically confirmed bone metastasis, which is assessed by the investigator to require local radiotherapy treatment;
- Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);
- Adenocarcinoma patients have been confirmed by tumour histology or cytology or haematology that the driver genes (EGFR, ALK, ROS-1) are all negative, and genetic testing is not required for squamous cell carcinoma...
- At least 1 evaluable lesion other than bone metastases (refer to RECIST1.1), and lymph nodes can be used as independent measurable lesions;
- Bone metastases other than the lesions to be radiotherapy do not require local treatment (surgery or radiotherapy) intervention after evaluation;
- ECOG score 0-1 points;
- Expected survival time \> 3 months;
- Adequate organ function, people need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) ≥ 1.5x109/L; 2) In...
- The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
- The lesion is an isolated lesion and can be treated radically;
- Patients who need surgical treatment after the evaluation of the study are not allowed to enroll;
- The radiotherapy lesion to be treated has been treated with radiotherapy or the lesion to be treated cannot be treated with radiotherapy after evaluation;
- Presence of active brain metastases;
- Diagnosis of other malignant diseases other than NSCLC within 5 years before the first dose (excluding radically cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in...
- Current participation in treatment clinical study treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks prior to the first dose;
- Prior treatment with the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137) or targeting RANKL...
- Active autoimmune disease requiring systemic therapy (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine...
- Presence of clinically uncontrollable pleural effusion/ascites effusion (people who do not need to drain the effusion or stop draining for 3 days without significant increase in effusion can be enrolled);
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Presence of active bone metabolism disease (Paget bone disease, Cushing's syndrome, and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper/hypothyroidism, hyperparathyroidism/hypoparathyroidism;
- Those who are known to be allergic to the active ingredients or excipients such as sintilimab, pemetrexed, nalusopaimab, carboplatin, cisplatin, paclitaxel, etc., of the drug in this study;
- Have not recovered adequately from toxicity and/or complications induced by any of the interventions (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected at the same time greater than the upper limit of normal in the laboratory department of the research center);
- Hypocalcemia cannot be improved after treatment;
- Previous or current osteomyelitis or osteonecrosis of the jaw; Dental surgery or oral surgery that does not heal; Acute dental or jaw disease requiring oral surgery; Those who plan to undergo invasive dental surgery...
- Use of any of the following anti-bone metabolizing agents within 6 months prior to enrollment: Parathyroid hormone (PTH) or derivatives; Calcitonin; Osteoprotein; Vaccination with a live vaccine within 30 days prior to...
- Pregnant or lactating women;
- Presence of any serious or uncontrollable systemic disease, such as:
- Resting ECG has major abnormalities in rhythm, conduction or morphology and severe symptoms that are difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia...
- unstable angina, congestive heart failure, New York Heart Association (NYHA) classification ≥ grade 2 chronic heart failure;
- myocardial infarction within 6 months prior to enrollment;
- unsatisfactory blood pressure control;
- History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or current presence of clinically active interstitial lung disease;
- active tuberculosis;
- Presence of active or uncontrolled infection requiring systemic therapy;
- Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- poorly controlled diabetes mellitus (fasting blood glucose (FBG) \>10mmol/L);
- Those whose urine routine showed a urine protein ≥++, and confirmed that the 24-hour urine protein was \> 1.0 g;
- people with mental disorders who are unable to cooperate with treatment; Medical history or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.