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History of Changes for Study: NCT02767804
eXalt3: Study Comparing X-396 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Latest version (submitted October 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 9, 2016 None (earliest Version on record)
2 June 29, 2016 Recruitment Status, Contacts/Locations, Study Status and Oversight
3 August 9, 2016 Contacts/Locations and Study Status
4 August 16, 2016 Contacts/Locations and Study Status
5 September 21, 2016 Arms and Interventions, Contacts/Locations, Study Description, Study Status and Study Identification
6 September 30, 2016 Contacts/Locations and Study Status
7 October 18, 2016 Contacts/Locations and Study Status
8 November 22, 2016 Contacts/Locations, Study Status and IPDSharing
9 November 28, 2016 Contacts/Locations and Study Status
10 January 10, 2017 Study Status and Contacts/Locations
11 March 11, 2017 Contacts/Locations and Study Status
12 March 15, 2017 Contacts/Locations and Study Status
13 May 19, 2017 Contacts/Locations and Study Status
14 March 5, 2018 Contacts/Locations, Study Status and Eligibility
15 July 12, 2018 Study Status, Contacts/Locations and Eligibility
16 January 15, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
17 March 1, 2019 Study Status
18 April 23, 2019 Study Design and Study Status
19 January 10, 2020 Study Status
20 July 1, 2020 Study Status
21 July 21, 2020 Outcome Measures and Study Status
22 August 27, 2020 Study Status
23 October 5, 2020 Study Status and Contacts/Locations
24 October 5, 2020 Contacts/Locations and Study Status
25 November 18, 2020 Oversight and Study Status
26 December 1, 2020 Study Status and Contacts/Locations
27 January 28, 2021 Study Status
28 January 14, 2022 Study Status, Contacts/Locations and Outcome Measures
29 October 18, 2022 Study Status
30 October 21, 2022 Study Status
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Study NCT02767804
Submitted Date:  May 9, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: X396-CLI-301
Brief Title: eXalt3: Study Comparing X-396 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Official Title: Phase 3 Randomized Study Comparing X-396 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2016
Overall Status: Not yet recruiting
Study Start: May 2016
Primary Completion: April 2020 [Anticipated]
Study Completion: April 2020 [Anticipated]
First Submitted: April 30, 2016
First Submitted that
Met QC Criteria:
May 9, 2016
First Posted: May 10, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 9, 2016
Last Update Posted: May 10, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Xcovery Holding Company, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The primary purpose of this study is to evaluate the efficacy and safety of X-396 vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
Detailed Description: To evaluate the efficacy and safety of X-396 vs. crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI), to obtain additional pharmacokinetic (PK) data from sparse PK sampling, to compare the quality of life (QoL) in patients receiving X-396 vs. crizotinib, to evaluate the status of exploratory biomarkers and correlate with clinical outcome, and to obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.
Open or close this module Conditions
Conditions: Non-small Cell Lung Cancer
Keywords: ALK-positive NSCLC
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 402 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: X-396
Eligible patients with ALK+ NSCLC will receive oral X-396 at 225mg QD with or without food until progression or unacceptable toxicity develops
Drug: X-396
oral ALK inhibitor
Active Comparator: crizotinib
Eligible patients with ALK+ NSCLC will receive oral crizotinib at 250mg BID with or without food until progression or unacceptable toxicity develops
Drug: crizotinib
oral ALK inhibitor
Other Names:
  • Xalkori
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival (PFS) as assessed by independent radiology review based on RECIST v. 1.1 criteria
[ Time Frame: 36 months ]

Secondary Outcome Measures:
1. Overall survival (OS)
[ Time Frame: 48 months ]

2. Objective response rate (ORR) based on independent radiology review
[ Time Frame: 36 months ]

3. PFS based on investigator assessment
[ Time Frame: 36 months ]

4. ORR based on investigator assessment
[ Time Frame: 36 months ]

5. Time to response based on independent radiology review
[ Time Frame: 36 months ]

6. Time to response based on investigator assessment
[ Time Frame: 36 months ]

7. Duration of response based on independent radiology review
[ Time Frame: 36 months ]

8. Duration of response based on investigator assessment
[ Time Frame: 36 months ]

Other Outcome Measures:
1. CNS response rate based on independent radiology review
[ Time Frame: 36 months ]

2. CNS response rate based on investigator assessment
[ Time Frame: 36 months ]

3. Time to CNS progression
[ Time Frame: 36 months ]

4. Percentage of patients with adverse events
[ Time Frame: 36 months ]

5. Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire
[ Time Frame: 36 months ]

6. Patient reported TTD as measured by Lung Cancer Symptom Scale (LCSS)
[ Time Frame: 36 months ]

7. Patient reported health-related quality of life (HRQoL) as measured by EORTC C30/LC13 QoL questionnaire
[ Time Frame: 36 months ]

8. Patient reported HRQoL as measured by LCSS
[ Time Frame: 36 months ]

9. Plasma concentrations (Cmax) at participating sites
[ Time Frame: 36 months ]

10. Plasma concentrations (Cmin) at participating sites
[ Time Frame: 36 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. Patients may have received up to 1 prior chemotherapy regimen, which may also include maintenance therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
  • Life expectancy of at least 12 weeks.
  • Ability to swallow and retain oral medication.
  • Adequate organ system function.
  • Brain metastases allowed if asymptomatic at study baseline.
  • Men willing to use adequate contraceptive measures.
  • Women who are not of child-bearing potential, and women of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum or urine pregnancy test.
  • Patients must be at least 18 years of age.
  • Patients must have measurable disease per RECIST v. 1.1.
  • Patients must be ALK-positive by IHC.
  • Willingness and ability to comply with the trial and follow-up procedures.
  • Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

  • Patients that have previously received an ALK TKI, and patients currently receiving cancer therapy.
  • Use of an investigational drug within 21 days prior to the first dose of study drug.
  • Any chemotherapy within 4 weeks, or major surgery or radiotherapy within the last 14 days.
  • Patients with primary CNS tumors and leptomeningeal disease are ineligible.
  • Patients with a previous malignancy within the past 3 years.
  • Concomitant use of drugs with a risk of causing Torsades de Pointes. -Concomitant use of herbal medications.
  • Patients receiving strong CYP3A inhibitors or inducers.
  • Women who are pregnant or breastfeeding.
  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
  • Clinically significant cardiovascular disease.
  • Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have interstitial lung disease/pneumonitis, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.
  • Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
Open or close this module Contacts/Locations
Locations: United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Open or close this module IPDSharing
Plan to Share IPD: Yes
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Links:
Available IPD/Information:

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