LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
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| ClinicalTrials.gov Identifier: NCT01828112 |
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Recruitment Status :
Active, not recruiting
First Posted : April 10, 2013
Results First Posted : July 27, 2017
Last Update Posted : June 11, 2020
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Non-Small Cell Lung Cancer |
| Interventions |
Drug: Ceritinib Drug: pemetrexed Drug: docetaxel |
| Enrollment | 231 |
Participant Flow
| Recruitment Details | 115 patients received ceritinib and 116 received chemotherapy among which 40 patients received pemetrexed, 73 patients received docetaxel, and 3 were not treated (2 patients due to Investigators decision and 1 due to subject/guardian’s decision). |
| Pre-assignment Details | A total of 231 patients were randomized in a 1:1 ratio to the ceritinib arm (n=115) or the chemotherapy arm (n=116). |
| Arm/Group Title | Ceritinib | Chemotherapy |
|---|---|---|
 Arm/Group Description |
Ceritinib 750 mg | Chemotherapy as determined by BIRC. |
| Period Title: Overall Study | ||
| Started | 115 | 116 |
| Entered Extension Treatment Phase | 0 | 74 |
| Entered Post-treatment Follow-up Phase | 7 | 5 |
| Entered Survival Follow-up Phase | 61 | 19 |
| Discontinued From Study | 14 | 10 |
| Untreated Patients | 0 | 3 [1] |
| Untreated | 0 | 3 |
| Treated | 115 | 113 |
| Completed | 33 [2] | 8 [2] |
| Not Completed | 82 | 108 |
| Reason Not Completed | ||
| Adverse Event | 6 | 8 |
| Death | 9 | 5 |
| Physician Decision | 5 | 5 |
| Progressive disease | 56 | 82 |
| Subject/guardian decision | 6 | 8 |
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[1]
untreated = did not receive study drug
[2]
Completed = Ongoing at time of data cut-off of 26-Jan-2016
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Baseline Characteristics
| Arm/Group Title | Ceritinib | Chemotherapy | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Ceritinib 750 mg | Chemotherapy as determined by BIRC. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 115 | 116 | 231 | |
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Baseline Analysis Population Description |
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 115 participants | 116 participants | 231 participants | |
| 53.1 (11.96) | 54.4 (11.61) | 53.7 (11.78) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 115 participants | 116 participants | 231 participants | |
| Female |
68 59.1%
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61 52.6%
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129 55.8%
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| Male |
47 40.9%
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55 47.4%
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102 44.2%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 115 participants | 116 participants | 231 participants | |
| Asian |
30 26.1%
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38 32.8%
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68 29.4%
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| Black |
0 0.0%
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1 0.9%
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1 0.4%
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| Caucasian |
81 70.4%
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68 58.6%
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149 64.5%
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| Other |
2 1.7%
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4 3.4%
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6 2.6%
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| Unknown |
2 1.7%
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5 4.3%
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7 3.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
Although 116 patients were randomized to the Chemotherapy arm, 3 did not receive study drug and were excluded form the Safety set.
More Information
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
| EMail: | trialandresults.registries@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01828112 |
| Other Study ID Numbers: |
CLDK378A2303 2012-005637-36 ( EudraCT Number ) |
| First Submitted: | April 2, 2013 |
| First Posted: | April 10, 2013 |
| Results First Submitted: | June 24, 2017 |
| Results First Posted: | July 27, 2017 |
| Last Update Posted: | June 11, 2020 |