LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01828099|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2013
Results First Posted : September 21, 2017
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Ceritinib Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer|
|Actual Study Start Date :||July 9, 2013|
|Actual Primary Completion Date :||June 24, 2016|
|Estimated Study Completion Date :||July 22, 2019|
Ceritinib patients were on continuous oral dosing of ceritinib 750 mg once daily in fasted state.
Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule. Ceritinib (LDK378) was the investigational treatment and is referred to as the investigational study treatment/drug.
Other Name: LDK378
Active Comparator: Chemotherapy
Chemotherapy patients (Induction per Investigator's choice) were on four 21-day cycles of Pemetrexed 500mg/m2 iv + Cisplatin 75 mg/m2 or Pemetrexed 500 mg/m2 iv + Carboplatin AUC 5-6 iv followed by Pemetrexed 500 mg/m2 every 21 days followed by Pemetrexed maintenance in non-progressors, etc (other usual rule to stop treatment).
Pemetrexed was administered at a dose of 500 mg/m2 as an iv infusion on Day 1 of each 21-day cycle to patients randomized to the chemotherapy arm.
Cisplatin was administered by IV at a dose of 75 mg/m2 every 21 days for up to 4 cycles.
Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles
- Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC) [ Time Frame: from the date of randomization to the date of first radiologically documented disease progression or death due to any cause (assessed every 6 weeks up to approximately 34 months) ]PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause
- Overall Survival (OS) [ Time Frame: From randomization until death (up to approximately 34 months) ]OS defined as time from date of randomization to date of death due to any cause
- Overall Response Rate (ORR) [ Time Frame: From randomization until death (up to approximately 34 months) ]ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Review Committee (BIRC) and by investigator assessment per RECIST 1.1
- Duration of Response (DOR) [ Time Frame: From randomization until death (up to approximately 34 months) ]DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause
- Disease Control Rate (DCR) [ Time Frame: From randomization until death (up to approximately 34 months) ]DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD)
- Time to Response (TTR) [ Time Frame: From randomization until death (up to approximately 34 months) ]TTR defined as the time from date of randomization to date of first documented response (CR or PR)
- Patient Reported Outcomes [ Time Frame: Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks. ]The time to definitive deterioration from the date of randomization to the date of event for disease related symptoms.
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): NCT01828099
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|