由Research医药人Daniel整理发布。
重磅临床，AZ PD-L1与 贝达 ALK抑制剂X-396联用。在美国开展一二期临床。应该是突破性事件。
Collaborators:
MedImmune LLC
Xcovery Holding Company, LLC
Cancer Research Institute, New York City
临床试验信息：
A Study of ALK Inhibitor, Ensartinib, and Anti-PD-L1, Durvalumab, in Subjects With ALK-rearranged Non-small Cell Lung Cancer
ClinicalTrials.gov Identifier:
NCT02898116
First Posted: September 13, 2016
Last Update Posted: August 29, 2017
This is an open-label, multicenter, single-arm study to evaluate the safety and preliminary efficacy of a targeted therapy for NSCLC in combination with a checkpoint inhibitor:
Ensartinib (X-396), an anaplastic lymphoma kinase (ALK) Inhibitor and
Durvalumab (MEDI4736), an anti-programmed cell death ligand 1 (PD-L1) antibody.
Primary Outcome Measures:
Number of Adverse Events [ Time Frame: up to 17 months ]
Clinical laboratory tests, vital signs and weight measurements, physical exams, ECG, Eastern Cooperative Oncology Group (ECOG) performance status evaluation, imaging scans and any other medically indicated assessments, including subject interviews, will be performed to detect new abnormalities and deterioration of any preexisting conditions. The Investigator will evaluate any laboratory abnormalities for clinical significance, and clinically significant abnormalities will be recorded as adverse events. All treatment-emergent clinically significant abnormalities and deterioration from time of signing the informed consent to the end of study visit will be recorded in the Case Report Forms (CRFs) as adverse events and graded according to the CTCAE Version 4.03.
Secondary Outcome Measures:
Progression Free Survival Rate [ Time Frame: up to 24 weeks ]
Response Rate [ Time Frame: up to 24 weeks ]
Overall Best Response [ Time Frame: up to 48 weeks ]
Disease Control Rate (DCR) [ Time Frame: up to 48 weeks ]
Duration of Response (DoR) [ Time Frame: up to 48 weeks ]
Progression Free Survival (PFS) [ Time Frame: up to 5 years ]
Overall Survival [ Time Frame: up to 5 years ]
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| Estimated Enrollment: | 32 |
| Actual Study Start Date: | March 1, 2017 |
| Estimated Study Completion Date: | December 2023 |
| Estimated Primary Completion Date: | May 2019 (Final data collection date for primary outcome measure) |
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| Experimental: Esartinib monotherapy There will be a run-in period where ensartinib will be given as monotherapy for 2 cycles. Subjects who do not qualify for combination treatment may continue on monotherapy. | Drug: Ensartinib Ensartinib is taken orally, once per day. In this study, the starting dose for ensartinib will be 200 mg, which is considered an efficacious dose. Based on the results of the dose escalation phase, this dose may be escalated to the recommended ensartinib single agent dose of 225 mg or de-escalated to the minimum effective dose of 150 mg in the case of overlapping toxicities. Other Name: X-396 |
| Experimental: Combination Treatment Subjects who qualify for combination treatment will receive ensartinib (X-396) by mouth daily and durvalumab (MEDI4736) intravenously every 4 weeks. | Drug: Ensartinib Ensartinib is taken orally, once per day. In this study, the starting dose for ensartinib will be 200 mg, which is considered an efficacious dose. Based on the results of the dose escalation phase, this dose may be escalated to the recommended ensartinib single agent dose of 225 mg or de-escalated to the minimum effective dose of 150 mg in the case of overlapping toxicities. Other Name: X-396 Drug: DurvalumabA durvalumab dose of 1500 mg will be administered as a 60-minute IV infusion every 4 weeks. Other Name: MEDI4736 |
Contacts
Locations
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| Research Facility |
| Tampa, Florida, United States, 33612 |
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| Research Facility |
| New York, New York, United States, 10016 |
Sponsors and Collaborators
Ludwig Institute for Cancer Research
MedImmune LLC
Xcovery Holding Company, LLC
Cancer Research Institute, New York City
Investigators
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| Study Chair: | Leena Gandhi, MD, PhD | Laura & Isaac Perlmutter Cancer Center |
