Description:
The primary purpose of the study was to compare the antitumor activity of LDK378 versus
reference chemotherapy. Patients in the chemotherapy arm were allowed to cross-over to LDK378
after confirmed progressive disease (PD).
Title
- Brief Title: LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
CLDK378A2301
- SECONDARY ID:
2013-000319-26
- NCT ID:
NCT01828099
Conditions
- Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Ceritinib | LDK378 | Ceritinib |
Pemetrexed | | Chemotherapy |
Cisplatin | | Chemotherapy |
Carboplatin | | Chemotherapy |
Purpose
The primary purpose of the study was to compare the antitumor activity of LDK378 versus
reference chemotherapy. Patients in the chemotherapy arm were allowed to cross-over to LDK378
after confirmed progressive disease (PD).
Trial Arms
Name | Type | Description | Interventions |
---|
Ceritinib | Experimental | Ceritinib patients were on continuous oral dosing of ceritinib 750 mg once daily in fasted state. | |
Chemotherapy | Active Comparator | 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
- Cisplatin
- Carboplatin
|
Eligibility Criteria
Inclusion Criteria:
1. Patient has a histologically or cytologically confirmed diagnosis of non-squamous
Non-small cell lung cancer (NSCLC) that is Anaplastic lymphoma kinase (ALK) positive
as assessed by the Ventana Immunohistochemistry (IHC) test. The test will be performed
at Novartis designated central laboratories.
2. Patient has newly diagnosed stage IIIB (who are not a candidate for definitive
multimodality therapy) or stage IV NSCLC or relapsed locally advanced or metastatic
NSCLC not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic
drugs, monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other
targeted therapies, either experimental or not), with exception of neo-adjuvant or
adjuvant therapy
3. Patient has at least one measurable lesion as defined by RECIST 1.1.
Exclusion Criteria:
1. Patient with known hypersensitivity to any of the excipients of LDK378
(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and
magnesium stearate)
2. Patient with a history of severe hypersensitivity reaction to platinum containing
drugs, pemetrexed or any known excipients of these drugs.
3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically
unstable or has required increasing doses of steroids within the 2 weeks prior to
screening to manage CNS symptoms.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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) |
Safety Issue: | |
Description: | 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 |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | From randomization until death (up to approximately 34 months) |
Safety Issue: | |
Description: | OS defined as time from date of randomization to date of death due to any cause |
Measure: | Overall Response Rate (ORR) |
Time Frame: | From randomization until death (up to approximately 34 months) |
Safety Issue: | |
Description: | 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 |
Measure: | Duration of Response (DOR) |
Time Frame: | From randomization until death (up to approximately 34 months) |
Safety Issue: | |
Description: | 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 |
Measure: | Disease Control Rate (DCR) |
Time Frame: | From randomization until death (up to approximately 34 months) |
Safety Issue: | |
Description: | DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD) |
Measure: | Time to Response (TTR) |
Time Frame: | From randomization until death (up to approximately 34 months) |
Safety Issue: | |
Description: | TTR defined as the time from date of randomization to date of first documented response (CR or PR) |
Measure: | Patient Reported Outcomes |
Time Frame: | Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks. |
Safety Issue: | |
Description: | The time to definitive deterioration from the date of randomization to the date of event for disease related symptoms. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- Non-Small Cell Lung Cancer
- NSCLC
- ALK
- LDK378
- Non-small cell lung carcinoma (NSCLC)
- treatment of lung cancer after first metastasis
- lung cancer
- lung adenocarcinoma
- Non small cell lung carcinoma
- Non small cell lung cancer
- non-squamous non-small cell lung cancer
Last Updated
August 3, 2021