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New treatment option for Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Official title Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07061535
What this study is testing
What is Tafolecimab?
Tafolecimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for extensive-stage small cell lung cancer (es-sclc).
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 is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-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 and older
You may be able to join if
- Age ≥18 years, ECOG performance status 0-1;
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group...
- Previously not receiving systemic treatment for ES-SCLC;
- Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;
- Expected survival \>= 12 weeks;
You likely can't join if
- Previously receiving systemic anti-tumor therapy for ES-SCLC;
- Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;
- Receiving other investigational drugs or participated in other treatment clinical studies within 4 weeks before signing the informed consent form;
- Receiving systemic immunostimulant treatment within 4 weeks before enrollment;
- Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);
- Severe cardiovascular disease;
See the full eligibility criteria
- Age ≥18 years, ECOG performance status 0-1;
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria;
- Previously not receiving systemic treatment for ES-SCLC;
- Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;
- Expected survival \>= 12 weeks;
- Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing). Key
- Previously receiving systemic anti-tumor therapy for ES-SCLC;
- Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;
- Receiving other investigational drugs or participated in other treatment clinical studies within 4 weeks before signing the informed consent form;
- Receiving systemic immunostimulant treatment within 4 weeks before enrollment;
- Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);
- Severe cardiovascular disease;
- Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;
- Active hepatitis B virus (HBV)/ hepatitis C virus (HCV)/ human immunodeficiency virus (HIV) infection;
- Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases;
- Pregnancy or lactation;
- Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;
- Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion;
- Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;
- Known to be allergic to Sintilimab or Tafolecimab or its excipients, having a history of severe allergic reaction to any monoclonal antibody, or having a history of allergy to cisplatin, carboplatin or etoposide;
- Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;
- Creatinine clearance rate \< 60 mL/min (cisplatin) or \< 45 mL/min (carboplatin)
- Uncontrolled or symptomatic hypercalcemia.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Jinan, Shandong, China
- Hangzhou, Zhejiang, 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 Changsha, Hunan, China; Jinan, Shandong, China; Hangzhou, Zhejiang, 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.