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Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898116
Recruitment Status : Completed
First Posted : September 13, 2016
Results First Posted : August 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
MedImmune LLC
Xcovery Holding Company, LLC
Cancer Research Institute, New York City
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-small Cell Lung Cancer
Carcinoma
NSCLC
Interventions Drug: Ensartinib
Drug: Durvalumab
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ensartinib (200 mg)
Hide Arm/Group Description Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Adverse Event             1
Progressive disease             1
Arm/Group Title Ensartinib (200 mg)
Hide Arm/Group Description Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
All enrolled subjects
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
57
(48 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
 100.0%
1.Primary Outcome
Title Number of Subjects With Treatment-emergent Adverse Events
Hide Description Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the end of the study period. Dose-limiting toxicity (DLT) during the Run-in Period was defined as ≥ Grade 2 rash or other toxicity requiring discontinuation of ensartinib dosing.
Time Frame up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Ensartinib (200 mg)
Hide Arm/Group Description:
Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Any TEAE 2
Maximum grade 2 TEAE 1
Maximum grade 3 TEAE 1
Immune-related TEAE 0
Ensartinib-related TEAE 2
Serious TEAE 1
TEAE Leading to Discontinuation 1
TEAE Meeting DLT Criteria 0
2.Secondary Outcome
Title Number of Subjects With Best Overall Tumor Response at the Last Assessment
Hide Description Tumor response was evaluated using computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) at Baseline, every 2 cycles, and at the end of the study. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Time Frame up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Ensartinib (200 mg)
Hide Arm/Group Description:
Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
SD
0
   0.0%
PD
2
 100.0%
3.Secondary Outcome
Title Number of Subjects With Immune-related Tumor Response at the Last Assessment
Hide Description Immune-related tumor response was evaluated by computed tomography at Baseline, every 2 cycles, and at the end of the study. Tumor response was designated according to the immune-related Response Criteria (irRC) (Wolchok et al. Clin Cancer Res 2009;15:7412-20) into the following categories: immune-related complete response (irCR) requires disappearance of all lesions in two consecutive observations not less than 4 weeks apart; immune-related partial response (irPR) requires ≥ 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; immune-related stable disease (irSD) is assigned when neither a 50% decrease from baseline tumor burden nor a 25% increase in tumor burden from nadir can be established; immune-related progressive disease (irPD) requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart.
Time Frame up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Ensartinib (200 mg)
Hide Arm/Group Description:
Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
irSD
0
   0.0%
irPD
2
 100.0%
Time Frame All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 3 months.
Adverse Event Reporting Description AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
 
Arm/Group Title Ensartinib (200 mg)
Hide Arm/Group Description Subjects received ensartinib monotherapy (200 mg orally once daily) during a pre-immunotherapy Run-in Period for one to two 28-day cycles.
All-Cause Mortality
Ensartinib (200 mg)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Serious Adverse Events
Ensartinib (200 mg)
Affected / at Risk (%)
Total   1/2 (50.00%) 
Immune system disorders   
Hypersensitivity  1  1/2 (50.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ensartinib (200 mg)
Affected / at Risk (%)
Total   2/2 (100.00%) 
Blood and lymphatic system disorders   
Eosinophilia  1  1/2 (50.00%) 
Anaemia  1  1/2 (50.00%) 
Gastrointestinal disorders   
Nausea  1  1/2 (50.00%) 
General disorders   
Pyrexia  1  1/2 (50.00%) 
Fatigue  1  1/2 (50.00%) 
Investigations   
Blood alkaline phosphatase increased  1  1/2 (50.00%) 
Lymphocyte count decreased  1  1/2 (50.00%) 
Weight decreased  1  1/2 (50.00%) 
Metabolism and nutrition disorders   
Hyponatraemia  1  1/2 (50.00%) 
Hypoalbuminaemia  1  2/2 (100.00%) 
Hypocalcaemia  1  1/2 (50.00%) 
Decreased appetite  1  1/2 (50.00%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  1/2 (50.00%) 
Arthralgia  1  1/2 (50.00%) 
Nervous system disorders   
Dysgeusia  1  1/2 (50.00%) 
Psychiatric disorders   
Insomnia  1  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/2 (50.00%) 
Cough  1  1/2 (50.00%) 
Pleural effusion  1  1/2 (50.00%) 
Pulmonary oedema  1  1/2 (50.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Early termination due to the rapidly changing treatment landscape for ALK-positive NSCLC, resulting in low enrollment. Because only 2 subjects were enrolled, no separate statistical analysis plan was issued and no formal data analyses were performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Macri, Director, Clinical Trials Management
Organization: Ludwig Institute for Cancer Research
Phone: (212) 450-1546
EMail: mmacri@licr.org
Layout table for additonal information
Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT02898116    
Other Study ID Numbers: LUD2014-012-ALK
First Submitted: September 8, 2016
First Posted: September 13, 2016
Results First Submitted: July 26, 2018
Results First Posted: August 21, 2018
Last Update Posted: November 21, 2018