A Single-arm Phase II-study to Confirm Efficacy and Feasibility of Tarlatamab Treatment in Patients With Extensive Stage Small-cell Lung Cancer With Poor Performance Status
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 8
- 主要终点
- Overall Survival Rate at 12 Months
研究概览
简要总结
The SPACE-T study is a clinical trial for people with advanced small-cell lung cancer (SCLC) whose cancer has returned or spread despite previous treatment and whose general health is reduced (ECOG performance status 2). The study will include 57 participants at about 15 sites in Germany.
The study is testing tarlatamab, a treatment that helps the immune system recognize and attack cancer cells. Participants will receive tarlatamab through a vein, starting with a lower dose of 1 mg, followed by doses of 10 mg. Treatment will then generally be given every two weeks.
The main purpose of the study is to find out how effective tarlatamab is in this group of patients by assessing how many participants are alive 12 months after starting the study. The study will also examine how well the treatment controls the cancer, including cancer that has spread to the brain, how well participants tolerate the treatment, its side effects, and its impact on quality of life.
Patients with poorer general health are often not included in clinical trials, even though they represent an important part of the people treated for SCLC in everyday clinical practice. The SPACE-T study aims to provide more information about whether tarlatamab is effective and feasible for these patients.
详细描述
The SPACE-T study is a phase II clinical trial investigating the treatment tarlatamab in people with advanced small-cell lung cancer (SCLC). The study focuses specifically on patients whose cancer has returned or spread after previous treatment and whose general health and ability to carry out everyday activities are reduced (ECOG performance status 2). This patient group is often underrepresented in clinical trials, although it represents an important part of patients treated for SCLC in routine clinical practice.
A total of 57 patients are planned to participate at approximately 15 study sites in Germany. To take part, patients must be at least 18 years old and have confirmed small-cell lung cancer that has returned or spread to other parts of the body. They must have received at least one previous treatment for recurrent or metastatic disease. In general, previous treatment should have included platinum-based chemotherapy, etoposide and a PD-L1 inhibitor. Patients must also have cancer that can be measured on imaging examinations.
Patients with brain metastases may also participate in the study. However, patients cannot take part if brain metastases are causing new or worsening neurological symptoms. There are also other eligibility requirements relating, for example, to blood counts, liver and kidney function, breathing problems and previous cancer treatments. Patients who have previously received a treatment targeting DLL3 cannot participate.
All participants in the study will receive tarlatamab; there is no placebo or comparison group. Tarlatamab is a type of immunotherapy designed to bring the body's T cells into contact with cancer cells that carry a protein called DLL3. This is intended to help the immune system recognize and attack the cancer cells.
Tarlatamab is given through a vein. To reduce the risks associated with starting treatment, patients first receive a lower dose of 1 mg on the first day of treatment. They then receive the full 10 mg dose one week later and again one week after that. Afterwards, tarlatamab is generally given every two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Participants and investigators know that all participants receive tarlatamab.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the subject prior to performing any protocol-related procedures.
- •Age ≥ 18 years
- •ECOG performance status 2
- •Histologically confirmed small-cell lung cancer (initial mixed histology / combined SCLC permitted if re-biopsy of current progression shows SCLC)
- •Recurrent or metastatic disease. In case of local-only recurrence, availability of local treatment options must have been excluded
- •Has received at least one prior line of treatment in the recurrent or metastatic setting
- •Has received a prior treatment line with platinum, etoposide, and a PD-L1 antibody. Treatment with chemotherapy only is acceptable if the patient had a contraindication for CPI treatment
- •Measurable disease according to RECIST v1.1
排除标准
- •ECOG performance status 0, 1, 3 or 4
- •Life expectancy less than three months
- •Active brain metastases with unstable symptoms (new or progressive neurological symptoms within the last 3 weeks)
- •Bone marrow insufficiency:
- •neutrophil count < 1.5/nl or
- •hemoglobin <8 mg/dl or
- •platelets <100/nl
- •Advanced liver disease:
- •Subjects with pre-existing chronic liver disease:
- •iii. Total bilirubin > 1.5xULN or iv. ALT or AST > 3xULN
- •Subjects with no relevant prior chronic liver disease and elevated liver parameters due to liver metastases:
- •v. Total bilirubin > 3xULN or vi. ALT or AST > 10xULN c. International normalized ratio (INR) > 2.0 and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≥ 1.5 x ULN, except for subjects undergoing new class anticoagulant therapy (eg, Apixaban, Rivaroxaban, Edoxaban) with stable dose for 2 weeks prior to enrollment
- •Advanced kidney disease:
- •CKD-EPI GFR <20 ml/min/1.73m²
- •Heart failure with reduced ejection fraction (EF < 40%, assessed by echochardiography performed within 3 months prior to C1D1)
- •Hemodynamically significant pericardial effusion
- •Clinically significant pleural effusion (Clinically significant pleural effusions must be managed by drainage. Re-check within 3 days prior to initiation of treatment.)
- •Respiratory compromise leading to an unjustifiable risk in case of higher-grade CRS, in the judgment of the investigator (possible criteria leading to such judgment: oxygen support at rest >2l/min, active pneumonia or pneumonitis)
- •Prior DLL3-directed treatment
- •Prior systemic therapy (chemotherapy, CPI) within 14 days prior to first dose of study treatment
- •Previous treatment in the present study (does not include screening failure)
- •History of immune-mediated encephalitis
- •Concurrent malignancy other than SCLC requiring active treatment
- •HIV infection not on stable antiviral treatment
- •Women of childbearing potential or men with partners of childbearing potential who are not adhering to contraceptive measures
- •Female subjects of childbearing potential
- •unwilling to use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 60 days after the last dose of tarlatamab
- •who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab
- •planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab
- •with a positive pregnancy test at screening
- •Male subjects
- •with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab
- •with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab
- •unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab
- •Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
- •Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
研究组 & 干预措施
Tarlatamab
Participants receive tarlatamab intravenously at a step dose of 1 mg on Cycle 1 Day 1, followed by the target dose of 10 mg on Cycle 1 Day 8 and Cycle 1 Day 15, and every two weeks thereafter.
干预措施: Tarlatamab (Drug)
结局指标
主要结局
Overall Survival Rate at 12 Months
时间窗: 12 months
Percentage of participants who are alive 12 months after initiation of study treatment.
次要结局
- Overall Survival (OS)(From initiation of study treatment until death from any cause, assessed up to 48 months)
- Progression-Free Survival (PFS)(From initiation of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months)
- Objective Response Rate (ORR)(From initiation of study treatment until documented disease progression, assessed up to 48 months)
- Intracranial Objective Response Rate (iORR)(From initiation of study treatment until documented intracranial disease progression, assessed up to 48 months)
- Rate of Participants Tolerating Tarlatamab Until First Disease Assessment(From first dose until first scheduled disease assessment after 2 months)
- Safety and Tolerability of Tarlatamab(rom first dose of tarlatamab through the protocol-defined safety follow-up period, assessed up to 48 months)
- Time to Next-Line Systemic Therapy(From initiation of study treatment until initiation of the next-line systemic anticancer therapy, assessed up to 48 months)
- Quality of Life - EORTC QLQ-C30(From baseline through treatment and follow-up, assessed up to 48 months)
- Patient-Reported Symptoms - PRO-CTCAE(From baseline through treatment and follow-up, assessed up to 48 months)