NCT05089734进行中（未招募）3 期
Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 603
- 试验地点
- 445
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
- •Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.
- •Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.
- •No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.
- •Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.
- •Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
- •Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before randomization.
- •Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥ 1500/mm^3, and platelets ≥ 100,000/μL).
- •Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).
- •Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.
- •Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
排除标准
- •Mixed small-cell lung cancer and NSCLC histology.
- •Positive serum pregnancy test or women who are lactating.
- •Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.
- •Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent.
- •Previously received treatment with any of the following:
- •Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1
- •Trop-2-targeted therapy
- •Docetaxel as monotherapy or in combination with other agents
- •Active second malignancy
- •NSCLC that is eligible for definitive local therapy alone.
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Active cardiac disease
- •Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
- •Active serious infection requiring antibiotics.
- •Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
- •Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease.
- •Positive hepatitis C antibody and detectable hepatitis C viral load.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Docetaxel
Active Comparator
Participants will receive docetaxel 75 mg/m^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
干预措施: Docetaxel (Drug)
Sacituzumab Govitecan-hziy (SG)
Experimental
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
干预措施: Sacituzumab Govitecan-hziy (SG) (Biological)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 24.4 months
OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.
次要结局
- Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1(Up to 24.4 months)
- Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1(Up to 24.4 months)
- Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)(Up to 24.4 months)
- Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1(Up to 24.4 months)
- Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1(Up to 24.4 months)
- Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)(Up to 3.5 years)
- Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline(Up to 3.5 years)
- Time to First Deterioration in NSCLC-SAQ Total Score(Up to 24.4 months)
研究者
研究点 (445)
Loading locations...
相似试验
已完成
3 期
Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)Breast CancerNCT02574455Gilead Sciences529
进行中（未招募）
2 期
Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT05186974Gilead Sciences193
进行中（未招募）
3 期
Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)Metastatic Breast CancerNCT04639986Gilead Sciences331
进行中（未招募）
3 期
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)Endometrial CancerNCT06486441Gilead Sciences640
进行中（未招募）
2 期
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has SpreadMetastatic Urothelial CancerNCT03547973Gilead Sciences502