A Randomized, Multiregional, Open-Label Phase 3 Clinical Trial of ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 940
- 主要终点
- Progression-Free Survival (PFS) assessed by the Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases. Squamous carcinoma accounts for 20-30% of all NSCLC cases. The purpose of this study is to determine if ABBV-1480 plus chemotherapy works better than pembrolizumab plus chemotherapy in adult participants with NSCLC.
ABBV-1480 is an investigational drug being developed for the treatment of NSCLC. Participants will be randomized into 2 groups. One group will receive ABBV-1480 with platinum based chemotherapy. Another group will receive standard of care (SOC) pembrolizumab with platinum based chemotherapy. Up to approximately 940 adult participants with locally advanced (Stage IIIB/C) or metastatic (Stage IV) sqNSCLC, will be enrolled in the study in approximately 250 sites globally.
In this Phase 3 study one of two groups will receive doses of Intravenous (IV) ABBV-1480 + Carboplatin & Paclitaxel/ Nab-paclitaxel and other group will receive Intravenous (IV) Pembrolizumab + Carboplatin & Paclitaxel/ Nab-paclitaxel.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
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
- •Adult subjects with a histologically or cytologically confirmed diagnosis of Stage IIIB, IIIC, or IV sqNSCLC that is not amenable to curative treatment
- •At least one lesion with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the local site investigator/radiology assessment.
- •Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Adequate hematological, renal, hepatic, and coagulation function.
- •Females of childbearing potential must have a negative pregnancy test
排除标准
- •Prior systemic treatment received for locally advanced or metastatic NSCLC.
- •Histologically or cytologically confirmed non-sqNSCLC.
- •Known actionable genomic alterations (including EGFR, ALK, ROS1, BRAF, NTRK, RET, and MET) for which first-line approved therapies are available.
- •Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
研究组 & 干预措施
Pembrolizumab + chemotherapy
Participants will receive Pembrolizumab + chemotherapy(carboplatin and paclitaxel/nab-paclitaxel)
干预措施: Paclitaxel (Drug)
Pembrolizumab + chemotherapy
Participants will receive Pembrolizumab + chemotherapy(carboplatin and paclitaxel/nab-paclitaxel)
干预措施: Carboplatin (Drug)
ABBV-1480 + chemotherapy
Participants will receive ABBV-1480 + chemotherapy (carboplatin and paclitaxel/nab-paclitaxel)
干预措施: ABBV-1480 (Drug)
Pembrolizumab + chemotherapy
Participants will receive Pembrolizumab + chemotherapy(carboplatin and paclitaxel/nab-paclitaxel)
干预措施: Pembrolizumab (Drug)
Pembrolizumab + chemotherapy
Participants will receive Pembrolizumab + chemotherapy(carboplatin and paclitaxel/nab-paclitaxel)
干预措施: Nab- Paclitaxel (Drug)
ABBV-1480 + chemotherapy
Participants will receive ABBV-1480 + chemotherapy (carboplatin and paclitaxel/nab-paclitaxel)
干预措施: Nab- Paclitaxel (Drug)
ABBV-1480 + chemotherapy
Participants will receive ABBV-1480 + chemotherapy (carboplatin and paclitaxel/nab-paclitaxel)
干预措施: Carboplatin (Drug)
ABBV-1480 + chemotherapy
Participants will receive ABBV-1480 + chemotherapy (carboplatin and paclitaxel/nab-paclitaxel)
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) assessed by the Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Up to Approximately 60 Months
Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of radiographic progression as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by Blinded Independent Central Review (BICR) or death from any cause, whichever occurs first.
Overall Survival (OS)
时间窗: Up to Approximately 60 Months
Overall Survival (OS) is defined as the time from randomization to the event of death from any cause.
次要结局
- Objective Response Rate (ORR) assessed by blinded independent central review (BICR)(Up to Approximately 60 Months)
- Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ-C30(Up to Approximately 12 weeks)
- Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.(Up to Approximately 12 Weeks)
- Duration Of Response (DoR) assessed by Blinded Independent Central Review (BICR)(Up to Approximately 60 months)
- Disease Control Rate (DCR) assessed by Blinded Independent Central Review (BICR)(Up to Approximately 60 Months)
- Time To Response (TTR) assessed by Blinded Independent Central Review (BICR)(Up to Approximately 60 months)
- Progression-Free Survival (PFS) assessed by the investigator(Up to Approximately 60 Months)
- Objective Response Rate (ORR) assessed by the investigator(Up to Approximately 60 Months)
- Duration Of Response (DoR) assessed by the investigator(Up to Approximately 24 months)
- DCR assessed by the investigator(Up to Approximately 60 Months)
- TTR assessed by the investigator(Up to Approximately 60 months)
- Change from baseline at Week 12 in the coughing item as measured by the EORTC QLQ-LC13.(Up to Approximately 12 Weeks)
- Change from baseline at Week 12 in the pain in chest item as measured by the EORTC QLQLC13(Up to Approximately 12 weeks)
- Change in from baseline at Week 12 in dyspnea items as measured by the EORTC QLQ-LC13(Up to Approximately 12 weeks)