BridgeMD
New treatment option for SCLC, Limited Stage
Official title Study of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)
ClinicalTrials.gov ID: NCT06911606
What this study is testing
What is 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin?
4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin is an investigational medicine, being studied as a potential treatment for sclc, limited stage.
Also referred to as surgery.
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
- This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We aimed to evaluate the efficacy and safety of surgical resection or chemotherapy following serplulimab plus platinum-containing dual induction therapy for stage II-IIIB (N2) LS-SCLC
- 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 75
You may be able to join if
- Voluntarily participate in clinical research and sign written informed consent
- Male or female patients aged 18-75 years old (including the critical value)
- Histologically or cytologically confirmed SCLC
- Clinically diagnosed as IIB-IIIB ( N2) stage (AJCC 8th edition cancer staging)
- Patients who have not received systemic anti-tumor treatment or chest radiotherapy in the past
You likely can't join if
- Mixed SCLC confirmed by histology or cytology
- Previously received systemic anti-tumor treatment for small cell lung cancer, including but not limited to chemotherapy, immunotherapy, and...
- Other active malignant tumors within 5 years or at the same time. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell...
- Those who are planning to undergo or have received organs in the past or bone marrow transplant patients
- Pleural effusion, pericardial effusion or ascites requiring clinical intervention
- Myocardial infarction or poorly controlled arrhythmia (including men with QTc interval) within 6 months before the first administration of the study...
See the full eligibility criteria
Who can join
- Voluntarily participate in clinical research and sign written informed consent
- Male or female patients aged 18-75 years old (including the critical value)
- Histologically or cytologically confirmed SCLC
- Clinically diagnosed as IIB-IIIB ( N2) stage (AJCC 8th edition cancer staging)
- Patients who have not received systemic anti-tumor treatment or chest radiotherapy in the past
- By Surgeons evaluate patients who have no contraindications to surgery
- According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), there is at least one radiologically measurable lesion
- ECOG score 0-1
- Expected survival time \> 6 months
- Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), the hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \<2500 copies/mL or 500 IU/mL before inclusion...
- Laboratory tests within 7 days before the first use of the study drug confirm sufficient organ and bone marrow function, No serious hematopoietic abnormalities, cardiac, liver, renal dysfunction or immune deficiency (no...
- Female patients must meet one of the following conditions: a. Menopause (defined as the absence of menstruation for at least 1 year without other confirmed reasons other than menopause), or b. Have undergone surgical...
- Male patients must meet the following requirements: Agree to abstain from sex (avoid heterosexual intercourse) or take contraceptive measures, as follows: When the partner is a female of childbearing age or the partner...
- The end of previous non-systemic anti-tumor treatment must be ≥ 2 weeks from the start of medication, and according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0, treatment-related AEs reverted to grade...
What rules you out
- Mixed SCLC confirmed by histology or cytology
- Previously received systemic anti-tumor treatment for small cell lung cancer, including but not limited to chemotherapy, immunotherapy, and radiotherapy
- Other active malignant tumors within 5 years or at the same time. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of...
- Those who are planning to undergo or have received organs in the past or bone marrow transplant patients
- Pleural effusion, pericardial effusion or ascites requiring clinical intervention
- Myocardial infarction or poorly controlled arrhythmia (including men with QTc interval) within 6 months before the first administration of the study drug ≥450 ms, women ≥470 ms) (QTc interval is calculated by...
- The subject has uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or Corrected serum calcium \> ULN)
- The patient has grade ≥ 2 CTCAE peripheral neuropathy
- Human immunodeficiency virus (HIV) infection, HIV antibody test results are positive
- Suffering from active pulmonary tuberculosis
- Past and There are currently people with interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc. who are judged by the researcher to be likely to...
- Hepatitis B (HBsAg or HBcAb test is positive, and HBV-DNA test is positive), Hepatitis C (HCV antibody test is positive, and HCV-RNA test is positive). people with co-infection of hepatitis B and hepatitis C (positive...
- people have known active or suspected autoimmune diseases. people who are in stable condition and do not require systemic immunosuppressant treatment are allowed to enroll
- Those who have received live vaccine treatment within 28 days before the first dose. However, inactivated viral vaccines are allowed to treat seasonal influenza, but intranasal live attenuated influenza vaccines are not...
- Systemic corticosteroids (\> 10 mg/ people treated with prednisone effective doses) or other immunosuppressive drugs. However, the following conditions are allowed: in the absence of active autoimmune disease, people...
- Any active infection requiring systemic anti-infectious therapy within 14 days before study drug administration, or the subject has a positive RT-PCR test for SARS-CoV-2 infection at enrollment. people with a history of...
- Have undergone major surgery within 28 days before the first administration of the study drug. The definition of major surgery in this study: at least 3 weeks of recovery time are required after surgery before the...
- The subject has previously received other antibodies/drugs targeting immune checkpoints, such as PD-1, PD -L1, CTLA-4 and other treatments
- Are participating in other treatment clinical studies, or plan to start treatment in this study less than 28 days from the end of treatment in a previous treatment clinical study
- Known to have a risk for any monoclonal antibody History of severe allergies
- Known allergic reaction to carboplatin/cisplatin or etoposide components
- Pregnant or lactating women
- people known to have a history of psychotropic drug abuse or drug use
- According to the researcher's judgment, the subject has other factors that may cause the study to be terminated early.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.