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New treatment option for Perioperative Immunotherapy
Official title Perioperative Immunotherapy for Resectable Limited-Stage SCLC
ClinicalTrials.gov ID: NCT07109401
What this study is testing
What is Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)?
Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide) is an investigational medicine, being studied as a potential treatment for perioperative immunotherapy.
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
- For limited-stage small cell lung cancer (SCLC), surgical treatment is recommended for patients with T1-2N0M0 (I-IIA) by guidelines. However, whether perioperative immunotherapy extends radical surgery to stage IIB-IIIB patients with improved survival remains elusive.
- 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
- Able to provide written informed consent and understand and agree to comply with the study requirements and assessment schedule;
- Aged 18-75 years at the time of signing the informed consent form;
- Pathologically (histologically or cytologically) confirmed diagnosis of small cell lung cancer;
- Limited-stage disease (stage IIB-IIIB according to AJCC 8th edition) assessed by bronchoscopy, PET-CT, endobronchial ultrasound (EBUS)...
- No prior radiotherapy, chemotherapy, immunotherapy, surgery or other systemic treatments;
You likely can't join if
- Tumor histopathology indicates non-small cell lung cancer (NSCLC);
- Presence of clinically inactive or active brain metastases;
- Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), current ILD, or suspicion of such diseases...
- Receiving systemic corticosteroid therapy within 14 days prior to the first dose of study drug;
- Previous radiotherapy, chemotherapy, immunotherapy, surgery, or other systemic treatments;
- Any active malignancy within 2 years prior to enrollment;
See the full eligibility criteria
- Able to provide written informed consent and understand and agree to comply with the study requirements and assessment schedule;
- Aged 18-75 years at the time of signing the informed consent form;
- Pathologically (histologically or cytologically) confirmed diagnosis of small cell lung cancer;
- Limited-stage disease (stage IIB-IIIB according to AJCC 8th edition) assessed by bronchoscopy, PET-CT, endobronchial ultrasound (EBUS), mediastinoscopy, or percutaneous biopsy, deemed resectable with curative intent (R0...
- No prior radiotherapy, chemotherapy, immunotherapy, surgery or other systemic treatments;
- ECOG PS score of 0-1;
- Expected survival must be \>3 months;
- Adequate bone marrow reserve and organ function within 30 days prior to enrollment meeting criteria for receiving platinum-based doublet chemotherapy;
- No contraindications for immunotherapy.
- Tumor histopathology indicates non-small cell lung cancer (NSCLC);
- Presence of clinically inactive or active brain metastases;
- Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), current ILD, or suspicion of such diseases based on imaging during screening;
- Receiving systemic corticosteroid therapy within 14 days prior to the first dose of study drug;
- Previous radiotherapy, chemotherapy, immunotherapy, surgery, or other systemic treatments;
- Any active malignancy within 2 years prior to enrollment;
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Uncontrolled or significant cardiovascular disease at the time of enrollment;
- Active or previously recorded autoimmune or inflammatory diseases before enrollment;
- History of active primary immunodeficiency disorders;
- Presence of active infections;
- Active bleeding disorders within ≤6 months prior to administration of the study drug, including gastrointestinal bleeding evidenced by hematemesis, severe hemoptysis, or melena;
- Non-healing wounds, active peptic ulcers, or fractures;
- Any condition that the investigator deems makes the patient unsuitable for participation in the study.
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 to 75 years. 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.