LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT01828099 |
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Recruitment Status :
Completed
First Posted : April 10, 2013
Results First Posted : September 21, 2017
Last Update Posted : January 24, 2024
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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: Cisplatin Drug: Carboplatin |
| Enrollment | 376 |
Participant Flow
| Recruitment Details | Patients were randomized in a 1:1 ratio to either ceritinib (750 mg once daily fasted) or chemotherapy (platinum-based doublet with pemetrexed followed by pemetrexed maintenance in patients without progressive disease after 4 cycles). |
| Pre-assignment Details | 376 patients completed the screening phase and were randomized to either ceritinib or chemotherapy arm in the treatment phase. 12 patients randomized to the chemotherapy arm were not treated. All patient randomized to ceritinib were treated. |
| Arm/Group Title | Ceritinib | Chemotherapy |
|---|---|---|
 Arm/Group Description |
Ceritinib 750 mg | Chemotherapy patients (Induction per Investigator's choice) |
| Period Title: Overall Study | ||
| Started | 189 | 187 |
| Untreated Patients | 0 | 12 |
| Treated | 189 [1] | 175 |
| Discontinued From Treatment Phase | 94 | 157 |
| Entered Extension-treatment Phase | 0 | 81 |
| Entered Post-treatment Follow-up Phase | 10 | 16 |
| Entered Survival Follow-up Phase | 64 | 31 |
| Discontinued From Study | 20 | 29 |
| Completed | 95 [2] | 30 [2] |
| Not Completed | 94 | 157 |
| Reason Not Completed | ||
| Adverse Event | 15 | 18 |
| Death | 9 | 11 |
| Lost to Follow-up | 2 | 0 |
| Non-compliance with study treatment | 2 | 0 |
| Physician Decision | 7 | 11 |
| Progressive disease | 51 | 94 |
| Protocol Violation | 1 | 0 |
| Subject/guardian decision | 7 | 23 |
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[1]
discontinued from treatment phase = Not completed
[2]
Completed = Patients ongoing at the time of data cut-off of 24-Jun-2016
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Baseline Characteristics
| Arm/Group Title | Ceritinib | Chemotherapy | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Ceritinib 750 mg | Chemotherapy patients (Induction per Investigator's choice) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 189 | 187 | 376 | |
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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. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 189 participants | 187 participants | 376 participants | |
| 54.5 (12.76) | 53.3 (12.49) | 53.9 (12.62) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 189 participants | 187 participants | 376 participants | |
| Female |
102 54.0%
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114 61.0%
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216 57.4%
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| Male |
87 46.0%
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73 39.0%
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160 42.6%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 189 participants | 187 participants | 376 participants | |
| Asian |
76 40.2%
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82 43.9%
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158 42.0%
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| Black |
3 1.6%
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3 1.6%
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6 1.6%
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| Caucasian |
104 55.0%
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98 52.4%
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202 53.7%
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| Native American |
3 1.6%
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2 1.1%
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5 1.3%
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| Other |
3 1.6%
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2 1.1%
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5 1.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
Among the 187 patients randomized to chemotherapy arm, 12 patients were not treated.
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: | NCT01828099 |
| Other Study ID Numbers: |
CLDK378A2301 2013-000319-26 ( EudraCT Number ) |
| First Submitted: | April 3, 2013 |
| First Posted: | April 10, 2013 |
| Results First Submitted: | June 23, 2017 |
| Results First Posted: | September 21, 2017 |
| Last Update Posted: | January 24, 2024 |