NCT04655976进行中（未招募）2 期
A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 758
- 试验地点
- 164
- 主要终点
- Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone
研究概览
简要总结
This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.
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
- •Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.
- •Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody.
- •Participant has measurable disease.
- •Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy.
- •Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
- •Participant has an ECOG performance status score of 0 or
- •Participant has a life expectancy of at least 3 months.
- •Participant has adequate Baseline organ function.
- •Participant has recovered from any prior treatment related toxicities.
- •Participant agrees to use contraception.
排除标准
- •Participant has been previously treated with an anti-PD-[L]1 or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation due to an AE.
- •Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel.
- •Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
- •Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) <=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.
- •Participant has received radiation to the lung that is >30 gray (Gy) within 6 months prior to the first dose of study treatment.
- •Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
- •Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) >2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkaline phosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment).
- •Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.
- •Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study.
- •Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
- •Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment.
- •Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible.
- •Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management.
- •Participant has pre-existing peripheral neuropathy that is Grade >=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria.
- •Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines.
- •Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose <=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).
研究组 & 干预措施
Participants receiving cobolimab+ dostarlimab+ docetaxel
Experimental
干预措施: Cobolimab (Biological)
Participants receiving cobolimab+ dostarlimab+ docetaxel
Experimental
干预措施: Dostarlimab (Biological)
Participants receiving cobolimab+ dostarlimab+ docetaxel
Experimental
干预措施: Docetaxel (Drug)
Participants receiving dostarlimab+ docetaxel
Experimental
干预措施: Dostarlimab (Biological)
Participants receiving dostarlimab+ docetaxel
Experimental
干预措施: Docetaxel (Drug)
Participants receiving docetaxel
Active Comparator
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone
时间窗: Up to approximately 52 months
OS is defined as survival from the date of randomization to the date of death by any cause.
OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone
时间窗: Up to approximately 52 months
OS is defined as survival from the date of randomization to the date of death by any cause.
Overall Survival (OS) (Arm A Versus Arm C)
时间窗: Up to approximately 234 weeks
OS is defined as the time from the date of randomization to the date of death due to any cause.
Overall Survival (OS) (Arm B Versus Arm C)
时间窗: Up to approximately 234 weeks
OS is defined as the time from the date of randomization to the date of death due to any cause.
次要结局
- OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel(Up to approximately 52 months)
- Objective response rate (ORR)(Up to approximately 52 months)
- Progression free survival (PFS)(Up to approximately 52 months)
- Duration of response (DOR)(Up to approximately 52 months)
- Time to deterioration (TTD)(Up to approximately 52 months)
- Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 item Core Module (EORTC QLQ-C30) assessment(Baseline (Day 1) and up to approximately 52 months)
- Change from Baseline in the EORTC QLQ LC13 assessment(Baseline (Day 1) and up to approximately 52 months)
- Number of participants with serious adverse events (SAEs)(From consent signature (Day -28) until the 90 day post last dose follow-up)
- Number of participants with treatment-emergent adverse events (TEAEs) and immune related adverse event (irAEs)(From consent signature (Day -28) until the 30 day post last dose follow-up)
- Number of participants with TEAEs leading to death(From consent signature (Day -28) until the 90 day post last dose follow-up)
- Number of participants with adverse events (AEs) leading to discontinuation(From consent signature (Day -28) until the 30 day post last dose follow-up)
- Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters(From consent signature (Day -28) until the 90 day post last dose follow-up)
- Number of participants with clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters(From consent signature (Day -28) until the 90 day post last dose follow-up)
- Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status(From consent signature (Day -28) until the 90 day post last dose follow-up)
- Number of participants with usage of concomitant medications(From consent signature (Day -28) until the 90 day post last dose follow-up)
- Number of participants with abnormal physical examinations(From consent signature (Day -28) until the 90 day post last dose follow-up)
- Overall Survival (OS) (Arm A Versus Arm B)(Up to approximately 234 weeks)
- Number of Participants Using Concomitant Medications(Up to 329 weeks)
- Overall Response Rate (ORR)(Up to approximately 234 weeks)
- Progression Free Survival (PFS)(Up to approximately 234 weeks)
- Duration of Response (DOR)(Up to approximately 234 weeks)
- Time to Deterioration (TTD) in Lung Cancer(Up to approximately 234 weeks)
- Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline(Up to 329 weeks)
- Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score(Baseline [Day(D) -1],D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks))
- Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment(Baseline (D -1),D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks))
- Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings(Baseline (Day-1) up to Cycle 1 Day 1)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Immune-mediate AEs (imAEs)(Up to 329 weeks)
- Number of Participants With TEAEs Leading to Death and Treatment Discontinuation(Up to 329 weeks)
- Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline(Up to 329 weeks)
- Number of Participants With Worst Case Thyroid Function Results by Maximum Grade Increase Post-Baseline Relative to Baseline(Up to 329 weeks)
- Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline(Up to 329 weeks)
- Number of Participants With Worst Case Vital Signs Results Relative to Normal Range Post-Baseline Relative to Baseline(Up to 329 weeks)
- Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Vital Signs(Baseline (Day -1) and Up to 281 weeks)
- Number of Participants With Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status(Up to 329 weeks)
- Number of Participants With Abnormal Physical Examinations(Up to approximately 234 weeks)
研究者
研究点 (164)
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