A Phase 2, Randomized, Open-Label, Active-Controlled Study of JNJ-90301900 in Combination With Chemoradiation Followed by Durvalumab in Locally Advanced and Unresectable Stage III NSCLC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 46
- 主要终点
- Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
研究概览
简要总结
The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.
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
- •Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening
- •Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
- •Have locally advanced unresectable stage III NSCLC according to the eighth edition lung cancer stage classification
- •Have at least 1 target lesion (primary lung lesion or involved lymph node[s]) per RECIST version 1.1 that is amenable to intratumoral and/or intranodal injection and intensity modulated radiation therapy (IMRT) as determined by the investigator at screening
- •Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
排除标准
- •Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression
- •Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IV
- •Another concurrent or prior primary malignancy within the last 36 months at informed consent
- •Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
- •History of coagulation disorders, including: (a) Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for JNJ-90301900 injection procedures, (b) Major thromboembolic events (for example, pulmonary embolism, cerebrovascular accident) within 3 months of enrollment or randomization
研究组 & 干预措施
Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume [GTV] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure.
干预措施: Durvalumab (Biological)
Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume [GTV] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT) (Radiation)
Part 2: Arm C: (Control treatment)
Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT) (Radiation)
Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume [GTV] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel (Drug)
Part 2: Arm A and Arm B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin (Drug)
Part 2: Arm C: (Control treatment)
Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel (Drug)
Part 2: Arm A and Arm B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT) (Radiation)
Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume [GTV] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin (Drug)
Part 2: Arm C: (Control treatment)
Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin (Drug)
Part 2: Arm A and Arm B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900.
干预措施: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel (Drug)
Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume [GTV] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure.
干预措施: JNJ-90301900 (Drug)
Part 2: Arm A and Arm B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900.
干预措施: JNJ-90301900 (Drug)
Part 2: Arm A and Arm B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900.
干预措施: Durvalumab (Biological)
Part 2: Arm C: (Control treatment)
Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.
干预措施: Durvalumab (Biological)
结局指标
主要结局
Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
时间窗: Up to 2 Years and 2 months
ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 using ICR assessments.
次要结局
- Time to Locoregional Failure (LRF)(Up to 2 Years and 2 months)
- Time to Distant Failure (DF)(Up to 2 Years and 2 months)
- Disease Control Rate (DCR) Post-cCRT and Pre-cIT(Up to 12 Weeks)
- Objective Response Rate (ORR) as Assessed by the Investigator(Up to 2 Years and 2 months)
- Progression Free Survival (PFS)(Up to 2 Years and 2 months)
- Duration of Response (DoR)(Up to 2 Years and 2 months)
- Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment(Up to 2 Years and 2 months)
- Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities(Up to 2 Years and 2 months)
- Objective Response Rate (ORR) Post-cCRT and Pre-cIT(Up to 12 Weeks)
- Progression Free Survival (PFS)(Up to 2 Years and 2 months)
- Disease Control Rate (DCR) Post-cCRT and Pre-cIT(Up to 12 Weeks)
- Objective Response Rate (ORR) as Assessed by the Investigator(Up to 2 Years and 2 months)
- Duration of Response (DoR)(Up to 2 Years and 2 months)
- Time to Locoregional Failure (LRF)(Up to 2 Years and 2 months)
- Time to Distant Failure (DF)(Up to 2 Years and 2 months)
- Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment(Up to 2 Years and 2 months)
- Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities(Up to 2 Years and 2 months)