2024-515765-34-00招募中3 期
A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- BioNTech SE
- 入组人数
- 58
- 试验地点
- 27
- 主要终点
- Overall survival (OS) defined as the time from randomization to death from any cause.
研究概览
简要总结
To assess the efficacy of BNT327 in combination with chemotherapy (etoposide plus carboplatin) followed by any subsequent therapy compared to atezolizumab in combination with chemotherapy (etoposide plus carboplatin) followed by any subsequent therapy in terms of a hazard ratio for overall survival (OS) in the intent-to-treat set (ITT Set).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures.
- •Are participants of child-bearing potential (POCBP) who have a negative serum beta-human chorionic gonadotropin test at screening within 7 days of the first investigational medicinal product (IMP) dose.
- •Are POCBP who agree to practice a highly effective form of contraception starting at the Screening Visit and continuously until 6 months after receiving the last dose of trial treatment or 7 months after the last dose of cisplatin, whichever is later, if cisplatin is received at any point during the induction period.
- •Men who are sexually active with a partner born female and have not had a vasectomy who agree to use condoms and to ask their sexual partners, to practice a highly effective form of contraception during the trial, starting at the Screening Visit and continuously until 6 months after receiving the last dose of trial treatment or 7 months after the last dose of cisplatin, whichever is later, if cisplatin is received at any point during the induction period.
- •Agree not to donate and/or cryopreserve germ cells (sperm, oocytes, ova) for the purposes of assisted reproduction during trial, starting at screening and continuously until 6 months after the last dose of trial treatment or 7 months after the last dose of cisplatin, whichever is later, if cisplatin is received at any point during the induction period.
- •Are willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, lifestyle restrictions, and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions.
- •Are 18 years of age or older at the time of giving informed consent.
- •Have histologically or cytologically confirmed extensive-stage small-cell lung cancer (ES-SCLC).
- •Have not had prior systemic therapy for ES-SCLC.
- •Have at least one measurable lesion as the targeted lesion based on RECIST v1.
- •ECOG performance status of 0 or
- •Have a body weight of at least 40 kg.
- •Have adequate hematologic (coagulation) and organ function (liver, kidney).
排除标准
- •Are pregnant or breastfeeding or are planning pregnancy or to father children during the trial or within 6 months after the last dose of IMP.
- •Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen test result at screening).
- •Have an active hepatitis C virus infection.
- •Have any of the heart conditions within 6 months prior to the trial treatment as specified in the study protocol.
- •Have hypertension or diabetic conditions prior to trial treatment as specified in the study protocol.
- •Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol-described requirements.
- •Have histologically or cytologically confirmed small-cell lung cancer (SCLC) with combined histologies.
- •Have received any of the therapies or drugs within the time intervals prior to trial treatment as per study protocol.
- •Have undergone major organ surgery, have significant trauma, or invasive dental procedures within 21 days prior to the trial treatment or plan to undergo elective surgery during the trial.
- •Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •Have any of the central nervous system metastases as described in the study protocol.
- •Have active autoimmune disease or history of autoimmune diseases with anticipated relapse, except for clinically stable autoimmune thyroid disease or Type-1 diabetes, or skin disorders including psoriasis, vitiligo, or alopecia.
- •Have adverse events (AEs) from prior antitumor therapy whose AE(s) have not returned to Grade 1 (graded by CTCAE 5.0 criteria) or below.
- •Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.
- •Have active, or a history of, pneumonitis requiring treatment with steroids, or has active, or a history of, interstitial lung disease.
- •Have active tuberculosis or have active syphilis infection.
- •Have an underlying condition that may increase the risk of the combination treatment or complicate the interpretation of AEs, as judged by the investigator, or other scenarios that the investigators consider the participant is not eligible for the trial.
- •Are vulnerable individuals as per ICH E6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
- •Have had other malignant tumors within 3 years prior to the trial treatment.
- •Have serious non-healing wounds or serious bone fractures.
- •Have significant risks of hemorrhage as defined in the study protocol.
- •Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Have a history of serious Grade 3 or higher immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy.
- •Have a known or suspected hypersensitivity to the trial treatments including any active ingredient or excipients thereof.
- •Have a known human immunodeficiency virus infection or known acquired immunodeficiency syndrome.
结局指标
主要结局
Overall survival (OS) defined as the time from randomization to death from any cause.
Overall survival (OS) defined as the time from randomization to death from any cause.
次要结局
- Occurrence of dose delay, infusion interruption, and discontinuation of study treatment due to TEAEs (including related TEAEs)
- Change from baseline in EORTC QLQ-C30 Global Health status / Quality-of-Life score (Items 29 and 30).
- Change from baseline in EORTC QLQ-C30 physical functioning
- Change from baseline in coughing scale of the EORTC quality-of-life-Lung cancer 29 questionnaire (QLQ-LC29).
- Change from baseline in shortness of breath scale of the EORTC QLQ-LC29.
- Change from baseline in "coughed up blood item" of the EORTC QLQ-LC29
- Change from baseline in the Functional Assessment of Cancer Therapy overall bother item (FACT-GP5).
- Progression-free survival (PFS) defined as the time from randomization to first objective tumor progression, or death from any cause, whichever occurs first.
- Objective response rate (ORR) defined as the proportion of participants in whom a complete response (CR) or partial response (PR) is observed as best overall response with confirmation.
- Duration of response (DOR) defined as the time from onset of objective response (confirmed CR or PR based on investigator’s assessment) to first occurrence of objective tumor progression (progressive disease) or death from any cause, whichever occurs first.
- Progression-free survival (PFS) rate based on investigator’s assessment at 6, 12, and 18 months.
- Overall survival (OS) rate at 6, 12, 18, and 24 months.
- Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs, by relationship.
研究者
Clinical Trial Information Desk
Scientific
BioNTech SE
研究点 (27)
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