BridgeMD
New treatment option for Small Cell Lung Cancer
Official title Serplulimab Combined With CCRT for LS-SCLC.
ClinicalTrials.gov ID: NCT06295926
What this study is testing
What is Serplulimab?
Serplulimab is an investigational medicine, being studied as a potential treatment for small cell lung cancer.
Also referred to as Concurrent radiotherapy Maintenance therapy, Etoposide.
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
- Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 15 months
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
- Aged 18 years or older
- Diagnosed with small cell lung cancer by histology or cytology, and staged as limited stage (stage II-III according to the 8th edition of AJCC Cancer...
- Treatment-naïve population, not having received any prior targeted therapy, chemotherapy, radiation therapy, or immunotherapy for anti-tumor treatment
- Measurable lesions based on RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. ECOG assessment should be conducted within 7 days prior to the first dose of...
You likely can't join if
- Patients with extensive-stage small cell lung cancer
- Cancer patients who have undergone surgery, radiotherapy, chemotherapy, or immunotherapy for small cell lung cancer
- LS-SCLC patients with stage I disease amenable to surgical resection
- Patients with active autoimmune diseases requiring systemic treatment (with disease-modifying agents, corticosteroids, or immunosuppressive drugs)...
- History of (non-infectious) pneumonia/interstitial lung disease requiring steroids or current active pneumonia/interstitial lung disease requiring...
- Previously diagnosed with immunodeficiency diseases such as immunoglobulin deficiency, aplastic anemia, etc.
See the full eligibility criteria
- Aged 18 years or older
- Diagnosed with small cell lung cancer by histology or cytology, and staged as limited stage (stage II-III according to the 8th edition of AJCC Cancer Staging)
- Treatment-naïve population, not having received any prior targeted therapy, chemotherapy, radiation therapy, or immunotherapy for anti-tumor treatment
- Measurable lesions based on RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. ECOG assessment should be conducted within 7 days prior to the first dose of the study intervention
- Baseline hematologic, blood biochemistry, and urine biochemistry tests confirming sufficient bone marrow and organ function
- Life expectancy of at least 6 months
- Male participants: Male participants must agree to use effective contraception during the study treatment and for at least 180 days after the last dose, and must not donate sperm during this period
- Female participants must not be pregnant or lactating, and must meet at least one of the following conditions:
- Women who are not capable of reproduction or
- Agree to use effective contraception during the treatment and for at least 180 days after the last dose
- Women capable of reproduction must undergo a serum or urine pregnancy test within 72 hours before starting the medication, and the result must be negative (minimum sensitivity 25 IU/L or equivalent units of HCG) (11)...
- Patients with extensive-stage small cell lung cancer
- Cancer patients who have undergone surgery, radiotherapy, chemotherapy, or immunotherapy for small cell lung cancer
- LS-SCLC patients with stage I disease amenable to surgical resection
- Patients with active autoimmune diseases requiring systemic treatment (with disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin...
- History of (non-infectious) pneumonia/interstitial lung disease requiring steroids or current active pneumonia/interstitial lung disease requiring steroids
- Previously diagnosed with immunodeficiency diseases such as immunoglobulin deficiency, aplastic anemia, etc.
- Known history of human immunodeficiency virus (HIV) infection
- Concurrent active hepatitis B (defined as HBV DNA \> 500 copies) and hepatitis C virus (defined as HCV RNA (+)) infection
- Known active tuberculosis history (tuberculin bacillus)
- Receipt of live vaccine or attenuated live vaccine within 30 days prior to the first study intervention. Use of inactivated vaccines is allowed. Live vaccines include, but are not limited to: measles, mumps, rubella...
- Known other malignancy within the past 1 year that is progressing or requires active treatment. Note: Excludes adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma (excluding in situ...
- Symptomatic central nervous system metastases and/or carcinomatous meningitis
- Severe hypersensitivity reaction (≥3 grade) to nivolumab/platinum/etoposide and/or any of their excipients
- Active infection requiring systemic therapy
- Any medical condition the investigator believes would pose excessive risk to the patient. For example, poorly controlled diabetes, active infection requiring parenteral anti-infective therapy, hepatic failure, any...
- Known psychiatric illness or substance abuse that would interfere with compliance with trial requirements
- Pregnancy, lactation, planned pregnancy, or intent to become pregnant or father children during the expected duration of the study (from screening visit through 180 days after the last dose of investigational drug)
- Prior allogeneic tissue/organ transplantation
- Patients unable to comply with study visits
- Currently participating in or has used other investigational drugs or devices
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 study runs about 15 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Beijing, Beijing 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.