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A Study of ALK Inhibitor, Ensartinib, and Anti-PD-L1, Durvalumab, in Subjects With ALK-rearranged Non-small Cell Lung Cancer

This study is currently recruiting participants.
Verified August 2017 by Ludwig Institute for Cancer Research
Sponsor:
ClinicalTrials.gov Identifier:
NCT02898116
First Posted: September 13, 2016
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
MedImmune LLC
Xcovery Holding Company, LLC
Cancer Research Institute, New York City
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research
  Purpose

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.

Condition Intervention Phase
Non-small Cell Lung Cancer Carcinoma NSCLC Drug: Ensartinib Drug: Durvalumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of ALK Inhibitor, Ensartinib (X-396), and Anti-PD-L1, Durvalumab (MEDI4736), in Subjects With ALK-rearranged (ALK-positive) Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

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 ]

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)
Arms Assigned Interventions
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: Durvalumab
A durvalumab dose of 1500 mg will be administered as a 60-minute IV infusion every 4 weeks.
Other Name: MEDI4736

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic confirmation of metastatic non-small cell lung cancer (NSCLC) and confirmed ALK rearrangement.
  • Measurable disease according to RECIST 1.1.
  • Availability of archival (diagnostic) specimens and willing to undergo a pre-treatment biopsy.
  • Subjects with treated brain metastases must have been treated with surgery and/or radiation therapy ≥ 21 days pre-study and must be clinically stable.
  • Laboratory parameters for vital functions should be in the normal range or not clinically significant.
  • Body weight > 30 kilograms.

Exclusion Criteria:

  • Treatment with an investigational agent within 4 weeks of starting treatment.
  • Prior treatment with anti-PD-1, PD-L1, or CTLA4, or ensartinib (X-396).
  • Active, suspected or prior documented autoimmune disease.
  • Subjects with clinically significant cardiovascular disease.
  • History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events.
  • Major surgery within 4 weeks of starting treatment.
  • Active infection including tuberculosis, hepatitis B or C, or human immunodeficiency virus.
  • History of allogenic organ transplant.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898116


Contacts
Contact: Kristen Aufiero 212-450-1515 clintrialinformation@licr.org

Locations
United States, Florida
Research Facility Not yet recruiting
Tampa, Florida, United States, 33612
United States, New York
Research Facility Recruiting
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
Study Chair: Leena Gandhi, MD, PhD Laura & Isaac Perlmutter Cancer Center
  More Information

Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT02898116     History of Changes
Other Study ID Numbers: LUD2014-012-ALK
First Submitted: September 8, 2016
First Posted: September 13, 2016
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ludwig Institute for Cancer Research:
ALK-rearranged
ALK-positive
ALK Inhibitor
Ensartinib
X-396
anti-PD-L1
Durvalumab
MEDI4736
ALK

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs