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New treatment option for Elderly Patients (>65 Years)
Official title Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC
ClinicalTrials.gov ID: NCT07086300
What this study is testing
- What it's testing
- The goal of this clinical trial is to elucidate the clinical efficacy and safety of electroacupuncture combined with PD-1 inhibitor therapy in elderly patients with advanced non-small cell lung cancer (NSCLC) through a multicenter, randomized controlled clinical trial. The main question it aims to answer is: the combination of electroacupuncture and PD-1 inhibitor therapy has demonstrated significant improvements in both clinical efficacy and safety profiles among elderly patients with advanced NSCLC.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 100
You may be able to join if
- Patients with stage IIIB-IV non-small cell lung cancer (NSCLC) confirmed by histopathological or cytological diagnosis.
- Patients with negative driver gene mutations, as determined by genetic testing or other molecular biological methods, to exclude common driver...
- Patients aged ≥65 years, with consideration for the patients' overall physical condition. Additional assessments will be conducted if there are...
- PD-L1 tumor proportion score (TPS) ≥1%.
- Estimated survival time \>3 months, as determined by clinical evaluation based on the patient's overall condition, tumor progression, and response to...
You likely can't join if
- Patients with a history of or concurrent other malignancies within the past 5 years.
- Patients with severe organ dysfunction or other serious comorbidities, such as heart failure (NYHA Class III-IV), hepatic or renal insufficiency, as...
- Patients with untreated central nervous system metastases. Only those who have undergone at least one course of systemic or surgical treatment and...
- Patients with psychiatric disorders, including a history of severe mental illnesses (e.g., schizophrenia, bipolar disorder) that require...
- Patients with a history of multiple drug allergies or an allergic constitution, particularly those who have experienced severe allergic reactions...
- Patients with active autoimmune diseases or infectious diseases, including but not limited to active or chronic viral hepatitis, active pulmonary...
See the full eligibility criteria
- Patients with stage IIIB-IV non-small cell lung cancer (NSCLC) confirmed by histopathological or cytological diagnosis.
- Patients with negative driver gene mutations, as determined by genetic testing or other molecular biological methods, to exclude common driver mutations such as EGFR mutations and ALK rearrangements.
- Patients aged ≥65 years, with consideration for the patients' overall physical condition. Additional assessments will be conducted if there are comorbidities or other factors that may affect their physical status.
- PD-L1 tumor proportion score (TPS) ≥1%.
- Estimated survival time \>3 months, as determined by clinical evaluation based on the patient's overall condition, tumor progression, and response to treatment.
- ECOG performance status score of 0-2.
- Patients with good treatment compliance, who are willing to sign an informed consent form, indicating their understanding and agreement to adhere to the study protocol for treatment and follow-up.
- Patients with a history of or concurrent other malignancies within the past 5 years.
- Patients with severe organ dysfunction or other serious comorbidities, such as heart failure (NYHA Class III-IV), hepatic or renal insufficiency, as assessed by routine examinations including liver function tests, renal...
- Patients with untreated central nervous system metastases. Only those who have undergone at least one course of systemic or surgical treatment and have been confirmed to have stable disease by imaging studies will be...
- Patients with psychiatric disorders, including a history of severe mental illnesses (e.g., schizophrenia, bipolar disorder) that require pharmacological treatment for control.
- Patients with a history of multiple drug allergies or an allergic constitution, particularly those who have experienced severe allergic reactions such as anaphylactic shock or allergic rashes.
- Patients with active autoimmune diseases or infectious diseases, including but not limited to active or chronic viral hepatitis, active pulmonary tuberculosis, or other infectious or autoimmune conditions deemed by the...
- Patients who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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, 65 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin 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.