A Phase I-II, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients with Resectable Stage I-III Non-Small Cell Lung Cancer, selected according to Biomarker Status
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 37
- 主要终点
- 1. Cohort B1: Incidence, type, and severity of adverse events with onset up to 28 days after the last dose of chemotherapy treatment according to NCI CTCAE v5.0.
研究概览
简要总结
The objective of this study was to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Following the study’s early closure, the objectives for cohort B1 have changed. The objectives for cohort B2 remain unchanged as no participants were enrolled in that cohort or are planned to be enrolled in that cohort. Cohort B1: To explore the safety of alectinib in combination with chemotherapy in patients with completely resected Stage II, IIIA, and selected IIIB (T3N2 only; as per AJCC eighth edition), anaplastic lymphoma kinase (ALK)-positive NSCLC Cohort B2:To evaluate the efficacy of neoadjuvant treatment with alectinib in combination with chemotherapy in patients with resectable Stage II, IIIA, and selected IIIB (T3N2 only; as per AJCC, Eighth Edition), ALK-positive NSCLC
研究设计
- 分配方式
- Na
- 主要目的
- Overview of Study Design
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Cohort B1: Complete resection of the primary NSCLC with negative margins
- •Cohort B1: Confirmed stage II-select IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology
- •Cohort B1: ECOG performance status of 0 or 1
- •Cohort B2: Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
- •Cohort B2: Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology
- •Cohort B1 and B2: Documented ALK fusion
排除标准
- •Cohort B1: NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
- •Cohort B1 and B2: Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •Cohort B1: Prior exposure to any systemic anti-cancer therapy
- •Cohort B2: Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
- •Cohort B2: Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin
- •Cohort B1:Prior exposure to any systemic anti-cancer therapy
研究组 & 干预措施
Pemetrexed Pfizer 25 mg/ml concentrate for solution for infusion., Pemetrexed Accord 25 mg/ml concentrate for solution for infusion, PEMETREXED, Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
干预措施: Pemetrexed Accord 25 mg/ml concentrate for solution for infusion (Drug)
Pemetrexed Pfizer 25 mg/ml concentrate for solution for infusion., Pemetrexed Accord 25 mg/ml concentrate for solution for infusion, PEMETREXED, Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
干预措施: Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion (Drug)
CARBOPLATINE ACCORD 10 mg/ml, solution pour perfusion, Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung, CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung, Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
干预措施: Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung, Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung, CISPLATINE ACCORD 1 mg/ml, solution à diluer pour perfusion
干预措施: Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung (Drug)
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung, Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung, CISPLATINE ACCORD 1 mg/ml, solution à diluer pour perfusion
干预措施: CISPLATINE ACCORD 1 mg/ml, solution à diluer pour perfusion (Drug)
Alectinib (Alecensa), Alecensa 150 mg hard capsules
干预措施: Alectinib (Alecensa) (Drug)
Alectinib (Alecensa), Alecensa 150 mg hard capsules
干预措施: Alecensa 150 mg hard capsules (Drug)
Pemetrexed Pfizer 25 mg/ml concentrate for solution for infusion., Pemetrexed Accord 25 mg/ml concentrate for solution for infusion, PEMETREXED, Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
干预措施: Pemetrexed Pfizer 25 mg/ml concentrate for solution for infusion. (Drug)
CARBOPLATINE ACCORD 10 mg/ml, solution pour perfusion, Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung, CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung, Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
干预措施: CARBOPLATINE ACCORD 10 mg/ml, solution pour perfusion (Drug)
CARBOPLATINE ACCORD 10 mg/ml, solution pour perfusion, Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung, CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung, Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
干预措施: Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung (Drug)
CARBOPLATINE ACCORD 10 mg/ml, solution pour perfusion, Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung, CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung, Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
干预措施: CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung (Drug)
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung, Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung, CISPLATINE ACCORD 1 mg/ml, solution à diluer pour perfusion
干预措施: Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung, Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung, CISPLATINE ACCORD 1 mg/ml, solution à diluer pour perfusion
干预措施: Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
Pemetrexed Pfizer 25 mg/ml concentrate for solution for infusion., Pemetrexed Accord 25 mg/ml concentrate for solution for infusion, PEMETREXED, Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
干预措施: PEMETREXED (Drug)
Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion, Pemetrexed Accord 25 mg/ml concentrate for solution for infusion, Pemetrexed Pfizer 25 mg/ml concentrate for solution for infusion., PEMETREXED
干预措施: PEMETREXED (Drug)
结局指标
主要结局
1. Cohort B1: Incidence, type, and severity of adverse events with onset up to 28 days after the last dose of chemotherapy treatment according to NCI CTCAE v5.0.
1. Cohort B1: Incidence, type, and severity of adverse events with onset up to 28 days after the last dose of chemotherapy treatment according to NCI CTCAE v5.0.
2. Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)
2. Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)
次要结局
- 1. Cohort B1:Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0). Adverse Events with onset up to 28 days after the last dose of study treatment, or until last on site/discontinuation visit, whichever comes first
- 2. Cohort B2:Investigator-assessed major pathological response (inv-MPR)
- 3. Cohort B2: Pathologic complete response (pCR) by independent review
- 4. Cohort B2: Major pathologic response (MPR) by independent review
- 5. Cohort B2: Investigator-assessed overall response rate (ORR) per RECIST v1.1
- 6. Cohort B2: Investigator-assessed event-free survival (EFS)
- 7. Cohort B2: OS
- 8. Cohort B2: Incidence, severity and type of AEs, with severity determined through use of NCI CTCAE v5.0
- 9. Cohort B2: Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters)
- 10. Cohort B2: Frequency of surgery completion, defined as patients who have successfully completed surgery without treatment related delays (> 60 days) from the last dose of neoadjuvant treatment
- 11. Cohort B2: Length of treatment related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations
- 10. Cohort B2: Investigator-assessed overall response rate (ORR) per RECIST v1.1
- 11. Cohort B2: Investigator-assessed event-free survival (EFS)
- 12. Cohort B2: OS
- 13. Cohort B2: Incidence, severity and type of AEs, with severity determined through use of NCI CTCAE v5.0
- 1. Cohort B1:Investigator-assessed disease-free survival (DFS)
- 2. Cohort B1:Disease-free rates at 1, 2, 3, 4, and 5 years
- 3. Cohort B1: Overall survival (OS)
- 4. Cohort B1:Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0). Adverse Events with onset up to 28 days after the last dose of study treatment
- 5. Cohort B1: Time to first onset of selected Adverse Events
- 6. Cohort B1:Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters). Baseline will be defined as the last assessment prior to first treatment
- 7. Cohort B2:Investigator-assessed major pathological response (inv-MPR)
- 8. Cohort B2: Pathologic complete response (pCR) by independent review
- 9. Cohort B2: Major pathologic response (MPR) by independent review
- 14. Cohort B2: Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters)
- 15. Cohort B2: Frequency of surgery completion, defined as patients who have successfully completed surgery without treatment related delays (> 60 days) from the last dose of neoadjuvant treatment
- 16. Cohort B2: Length of treatment related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG