An Open-label, Single-arm Continuation study for participants with ALKpositive or ROS1positive Non-small Cell Lung Cancer (NSCLC) continuing from Pfizer sponsored Lorlatinib clinical studies
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Pfizer Inc.
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- 1) Number of participants with adverse events leading to permanent discontinuation of study intervention
研究概览
简要总结
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention and no ongoing safety events in the Pfizer-sponsored lorlatinib parent studies (eg, B7461001, B7461006, B7461024, B7461027) that will be closed. This is an open-label continuation study for participants in the qualifying Parent Studies who are receiving lorlatinib as a single agent.
Lorlatinib will be self-administered by the participant at home in 28-day cycles, unless otherwise specified. Compliance will be assessed by counting returned tablets during the site visits and documented in the source documents and CRF.
The end of study is defined as when the last participant has discontinued from lorlatinib and has completed the safety follow-up period or 5 years after First Participant Dosed of the continuation study (whichever is sooner).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.
- •Participants must agree to follow the reproductive criteria as outlined in Protocol.
- •Adequate organ function- Adequate Bone Marrow, Liver, Renal, Pancreatic Function.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures. Capable of giving signed informed consent.
排除标准
- •Female participants who are pregnant or breastfeeding.
- •Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
结局指标
主要结局
1) Number of participants with adverse events leading to permanent discontinuation of study intervention
时间窗: 1) AEs leading to permanent | discontinuation of lorlatinib: Time Frame- Baseline up to approximately 5 years | 2) All SAEs: Time Frame- Baseline up to approximately 5 years
- Safety collection in this study will permit further characterization of the safety profile of lorlatinib
时间窗: 1) AEs leading to permanent | discontinuation of lorlatinib: Time Frame- Baseline up to approximately 5 years | 2) All SAEs: Time Frame- Baseline up to approximately 5 years
2) Number of serious adverse events reported for all participants
时间窗: 1) AEs leading to permanent | discontinuation of lorlatinib: Time Frame- Baseline up to approximately 5 years | 2) All SAEs: Time Frame- Baseline up to approximately 5 years
Safety collection in this study will permit further characterization of the safety profile of lorlatinib
时间窗: 1) AEs leading to permanent | discontinuation of lorlatinib: Time Frame- Baseline up to approximately 5 years | 2) All SAEs: Time Frame- Baseline up to approximately 5 years
次要结局
- Not provided(Not provided)