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New treatment option for NSCLC Stage IV
Official title Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Active Brain Metastasis
ClinicalTrials.gov ID: NCT06501378
What this study is testing
What is PD-1/PD-L1 inhibitor plus chemotherapy?
PD-1/PD-L1 inhibitor plus chemotherapy is an investigational medicine, being studied as a potential treatment for nsclc stage iv.
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
- Non-small cell lung cancer (NSCLC), the most prevalent form of lung cancer, has a significant risk of brain metastasis (BM). Historically, the median overall survival for advanced NSCLC patients with BM was under six months with traditional chemotherapy.
- 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 and older
You may be able to join if
- Age ≥ 18 years;
- KPS score ≥ 70;
- Negative genetic testing for common driver genes including EGFR, ALK, ROS-1;
- Pathologically confirmed non-small cell lung cancer;
- Clinical stage IV (AJCC, 8th edition, 2017);
You likely can't join if
- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or...
- Severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma...
- Patients judged by the researcher as unsuitable for brain MRI or stereotactic brain radiotherapy;
- EGFR, ALK, or ROS1 gene mutations;
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the...
- Symptomatic interstitial lung disease or active infection/non-infectious pneumonia;
See the full eligibility criteria
- Age ≥ 18 years;
- KPS score ≥ 70;
- Negative genetic testing for common driver genes including EGFR, ALK, ROS-1;
- Pathologically confirmed non-small cell lung cancer;
- Clinical stage IV (AJCC, 8th edition, 2017);
- Diagnosed with brain metastasis at the time of diagnosis, with at least one lesion in the brain with a diameter greater than 5mm on thin-section brain MRI;
- Active BMs that could not be controlled by symptomatic treatment, such as mannitol and dexamethasone
- Complete baseline assessment of systemic lesions before treatment, including enhanced brain MRI;
- Informed consent from the patient.
- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- Severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's...
- Patients judged by the researcher as unsuitable for brain MRI or stereotactic brain radiotherapy;
- EGFR, ALK, or ROS1 gene mutations;
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance;
- Symptomatic interstitial lung disease or active infection/non-infectious pneumonia;
- Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;
- Patients with active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable arrhythmia;
- Other uncontrollable diseases or findings from physical examination or clinical experiments judged by the researcher to potentially interfere with the results or increase the risk of treatment complications for the...
- Mixed with small cell lung cancer components;
- Pregnant or lactating women;
- Congenital or acquired immunodeficiency diseases including HIV, or history of organ transplantation, allogeneic stem cell transplantation;
- Known HBV, HCV, active pulmonary tuberculosis infection;
- Patients who have received tumor vaccines, or have been vaccinated with other vaccines within 4 weeks before starting treatment (Note: Seasonal influenza vaccines are usually inactivated vaccines and are allowed, while...
- Concurrent use of other immunomodulators, chemotherapy drugs, drugs in other clinical studies, and long-term use of corticosteroid treatment are not eligible for inclusion;
- Patients allergic or contraindicated to PD-1/PD-L1 inhibitors or chemotherapy drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.