A Phase 3 interventional study of Alectinib and Docetaxel in Non-small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 54 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).
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Exclusion Criteria:
Participants will receive oral alectinib at a dose of 600 milligrams (mg) twice daily, taken with food until disease progression, unacceptable toxicity, withdrawal of consent or death.
Drug: Alectinib
Participants will receive chemotherapy with either pemetrexed (500 milligrams per square meter \[mg/m\^2\] of body surface area) or docetaxel (75 mg/m\^2) intravenously.
Drug: Docetaxel · Drug: Pemetrexed
Participants will receive oral alectinib at a dose of 600 mg twice daily, taken with food until disease progression, unacceptable toxicity, withdrawal of consent or death.
Participants will receive docetaxel at a dose of 75 mg/m\^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.
Also known as: Taxotere®
Participants will receive pemetrexed at a dose of 500 mg/m\^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.
Also known as: Alimta®
Progression-Free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
Time frame: Randomization to first documented disease progression, death from any cause, or study end (up to 33 months)
Percentage of Participants With CNS Objective Response Rate (ORR) With Measurable CNS Metastases at Baseline Using RECIST Version 1.1 as Assessed By IRC
Overall response rate in subjects with confirmed CNS response (C-ORR) was defined as the percentage of subjects who attained Complete Response (CR) or Partial Response (PR) for lesions in the CNS. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: Baseline through study end (up to 33 months)
PFS Using RECIST Version 1.1 as Assessed by IRC
PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. This outcome measure was assessed as part of the primary analysis and was not repeated during final analysis.
Time frame: Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)
Percentage of Participants With Objective Response of CR or PR Using RECIST Version 1.1 as Assessed by Investigator and IRC
ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. The IRC assessment was part of the primary analysis and was not repeated during final analysis.
Time frame: Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)
Percentage of Participants With Disease Control Using RECIST Version 1.1 as Assessed by Investigator and IRC
Disease control rate (DCR) was defined as the percentage of participants who attained CR, PR, or stable disease (SD) of at least 5 weeks. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters since the treatment started. The IRC assessment was part of the primary analysis and was not repeated during final analysis.
Time frame: Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)
Duration of Response (DOR) Using RECIST Version 1.1 as Assessed by Investigator and IRC
DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR. The IRC assessment was part of the primary analysis and was not repeated during final analysis.
Time frame: From the first documented CR or PR to the first documented disease progression, death, or study end (up to 33 months)
PFS in C-ITT Population Using RECIST Version 1.1 as Assessed by Investigator and IRC
PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. This outcome measure assessment was part of the primary analysis and was not repeated during final analysis.
Time frame: Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)
Time to CNS Progression in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC
Time to CNS progression was defined as the time from randomization until radiographic evidence of CNS progression. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. This outcome measure assessment was part of the primary analysis and was not repeated during final analysis.
Time frame: Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)
Percentage of Participants With Disease Control in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC
Disease Control Rate (DCR) was defined as the percentage of participants who attained CR, PR, or stable disease (SD) of at least 5 weeks. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters since the treatment started.
Time frame: From first documented CR, PR, or SD lasting at least 5 weeks through study end (up to 33 months)
Percentage of Participants With ORR in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC
ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: Baseline through study end (up to 33 months)
Duration of Response for Lesions in the CNS (C-DOR) Using RECIST Version 1.1 as Assessed by IRC
DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. C-DOR was defined in a similar way for lesions in the CNS, taking into account all lesions in the body. DOR was evaluated for participants who had a BOR of CR or PR.
Time frame: From the first documented CR or PR to the first documented disease progression, death, or study end (up to 33 months)
Overall Survival (OS)
Overall survival (OS) was defined as the time from randomization to death from any cause. OS was confounded by cross-over of participants to the alectinib arm.
Time frame: Randomization to death from any cause, through study end (up to 33 months)
Plasma Concentration of Alectinib
Time frame: Predose (2 hours) at Baseline, Week 3 and Week 6
Plasma Concentration of Alectinib Metabolite
Time frame: Predose (2 hours) at Baseline, Week 3 and Week 6
Compliance of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Over Time
Percentage of participants who filled out an EORTC QLQ-C30 questionnaire at a visit. The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden.
Time frame: Baseline through Week 138
Compliance of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) Over Time
Percentage of participants who filled out an EORTC QLQ-LC13 questionnaire at a visit. The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Time frame: Baseline through Week 138
Compliance of European Quality of Life (EuroQoL) 5 Dimension 5 Levels (EQ-5D-5L) Questionnaire Over Time
Percentage of participants who filled out an ED-5D-5L questionnaire at a visit. EQ-5D-5L: A generic preference-based health utility measure that provides a single index value for health status. The instrument consists of two parts. The first part, health-state classification, contains five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: Baseline through Week 60
Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC13 Score for ITT Population
TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea \[single item and multi-item scales\] chest pain \[single item\], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-LC13.
Time frame: Baseline through study end (up to 33 months)
Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC13 Score for C-ITT Population
TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea \[single item and multi-item scales\] chest pain \[single item\], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-LC13.
Time frame: Baseline through study end (up to 33 months)
Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC30 Score for ITT Population
TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea \[single item and multi-item scales\] chest pain \[single item\], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-C30.
Time frame: Baseline through study end (up to 33 months)
Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC30 Score for C-ITT Population
TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea \[single item and multi-item scales\] chest pain \[single item\], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-C30.
Time frame: Baseline through study end (up to 33 months)
TTD in Composite of Three Symptoms (Cough, Dyspnea, and Chest Pain) Using EORTC QLQ-LC13 Score for C-ITT Population
TTD for a composite of three symptoms (cough, dyspnea, chest pain) in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for any component of the composite of the three following symptoms \[cough, dyspnea \[multi-item subscales QLQ-LC13\] and chest pain\]) as measured by the EORTC QLQ-LC13.
Time frame: Baseline through study end (up to 33 months)
TTD in Composite of Three Symptoms (Cough, Dyspnea, and Chest Pain) Using EORTC QLQ-LC13 Score for ITT Population
TTD for a composite of three symptoms (cough, dyspnea, chest pain) in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for any component of the composite of the three following symptoms \[cough, dyspnea \[multi-item subscales QLQ-LC13\] and chest pain\]) as measured by the EORTC QLQ-LC13.
Time frame: Baseline through study end (up to 33 months)
Percentage of Participants With Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Baseline through study end (up to 33 months)
The study recruited participants with Anaplastic Lymphoma Kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) in 13 countries from November 2015 to March 2017.
| Milestone | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Started | 79 | 40 |
| Completed | 36 | 17 |
| Not completed | 43 | 23 |
| Withdrew: Death | 32 | 16 |
| Withdrew: Progression of disease | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 6 |
| Withdrew: Other | 1 | 0 |
| Withdrew: Study termination by sponsor | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Physician decision | 2 | 0 |
PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Progression-Free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator | 10.9 (8.1 to 15.5) | 1.4 (1.2 to 1.6) |
Overall response rate in subjects with confirmed CNS response (C-ORR) was defined as the percentage of subjects who attained Complete Response (CR) or Partial Response (PR) for lesions in the CNS. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
| percentage of participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Percentage of Participants With CNS Objective Response Rate (ORR) With Measurable CNS Metastases at Baseline Using RECIST Version 1.1 as Assessed By IRC | 66.7 | 0.0 |
PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. This outcome measure was assessed as part of the primary analysis and was not repeated during final analysis.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| PFS Using RECIST Version 1.1 as Assessed by IRC | 7.1 (6.3 to 10.8) | 1.6 (1.3 to 4.1) |
ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. The IRC assessment was part of the primary analysis and was not repeated during final analysis.
| percentage of participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Assessed by Investigator | 50.6 | 2.5 |
| Assessed by IRC | 36.1 | 11.4 |
Disease control rate (DCR) was defined as the percentage of participants who attained CR, PR, or stable disease (SD) of at least 5 weeks. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters since the treatment started. The IRC assessment was part of the primary analysis and was not repeated during final analysis.
| percentage of participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Assessed by Investigator | 86.1 | 25.0 |
| Assessed by IRC | 76.4 | 48.6 |
DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR. The IRC assessment was part of the primary analysis and was not repeated during final analysis.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Assessed by Investigator | 12.0 (8.3 to 23.5) | 2.7 (NA to NA) |
| Assessed by IRC | 9.7 (5.6 to NA) | NA (NA to NA) |
PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. This outcome measure assessment was part of the primary analysis and was not repeated during final analysis.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Assessed by Investigator | 9.7 (6.9 to NA) | 1.4 (1.2 to 1.6) |
| Assessed by IRC | 8.1 (6.3 to NA) | 1.5 (1.2 to 4.1) |
Time to CNS progression was defined as the time from randomization until radiographic evidence of CNS progression. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions. This outcome measure assessment was part of the primary analysis and was not repeated during final analysis.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Time to CNS Progression in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC | NA (6.8 to NA) | 1.6 (1.3 to 9.9) |
Disease Control Rate (DCR) was defined as the percentage of participants who attained CR, PR, or stable disease (SD) of at least 5 weeks. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters since the treatment started.
| percentage of participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Percentage of Participants With Disease Control in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC | 82.7 | 25.0 |
ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
| percentage of participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Percentage of Participants With ORR in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC | 48.1 | 0.0 |
DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. C-DOR was defined in a similar way for lesions in the CNS, taking into account all lesions in the body. DOR was evaluated for participants who had a BOR of CR or PR.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Duration of Response for Lesions in the CNS (C-DOR) Using RECIST Version 1.1 as Assessed by IRC | 13.9 (6.2 to 13.9) | NA (NA to NA) |
Overall survival (OS) was defined as the time from randomization to death from any cause. OS was confounded by cross-over of participants to the alectinib arm.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Overall Survival (OS) | 27.8 (18.2 to NA) | NA (8.6 to NA) |
| nanogram/milliliter (ng/mL) | Experimental: Alectinib |
|---|---|
| Plasma Concentration of Alectinib | 559 ± 48.0 |
| ng/mL | Experimental: Alectinib |
|---|---|
| Plasma Concentration of Alectinib Metabolite | 240 ± 44.8 |
Percentage of participants who filled out an EORTC QLQ-C30 questionnaire at a visit. The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden.
| percentage of participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Baseline | 92.4 | 85.0 |
| Treatment - Week 3 | 96.1 | 83.3 |
| Treatment - Week 6 | 97.2 | 60.0 |
| Treatment - Week 12 | 95.5 | 80.0 |
| Treatment - Week 18 | 88.5 | 50.0 |
| Treatment - Week 24 | 91.1 | 100 |
| Treatment - Week 30 | 96.2 | 66.7 |
| Treatment - Week 36 | 89.8 | 66.7 |
| Treatment - Week 42 | 95.3 | 66.7 |
| Treatment - Week 48 | 100 | 100 |
| Treatment - Week 54 | 97.1 | 100 |
| Treatment - Week 60 | 100 | 100 |
| Treatment - Week 66 | 89.7 | 100 |
| Treatment - Week 72 | 88.9 | 100 |
| Treatment - Week 78 | 84.6 | — |
| Treatment - Week 84 | 78.3 | — |
| Treatment - Week 90 | 88.9 | — |
| Treatment - Week 96 | 93.8 | — |
| Treatment - Week 102 | 84.6 | — |
| Treatment - Week 108 | 100 | — |
| Treatment - Week 114 | 83.3 | — |
| Treatment - Week 120 | 100 | — |
| Treatment - Week 126 | 100 | — |
| Treatment - Week 132 | 100 | — |
| Treatment - Week 138 | 100 | — |
Percentage of participants who filled out an EORTC QLQ-LC13 questionnaire at a visit. The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
| percentage of participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Baseline | 92.4 | 82.5 |
| Treatment - Week 3 | 96.1 | 83.3 |
| Treatment - Week 6 | 97.2 | 63.3 |
| Treatment - Week 12 | 95.5 | 80.0 |
| Treatment - Week 18 | 88.5 | 50.0 |
| Treatment - Week 24 | 91.1 | 100 |
| Treatment - Week 30 | 96.2 | 66.7 |
| Treatment - Week 36 | 87.8 | 66.7 |
| Treatment - Week 42 | 95.3 | 66.7 |
| Treatment - Week 48 | 100 | 100 |
| Treatment - Week 54 | 97.1 | 100 |
| Treatment - Week 60 | 100 | 100 |
| Treatment - Week 66 | 89.7 | 100 |
| Treatment - Week 72 | 88.9 | 100 |
| Treatment - Week 78 | 84.6 | — |
| Treatment - Week 84 | 78.3 | — |
| Treatment - Week 90 | 88.9 | — |
| Treatment - Week 96 | 100 | — |
| Treatment - Week 102 | 84.6 | — |
| Treatment - Week 108 | 100 | — |
| Treatment - Week 114 | 83.3 | — |
| Treatment - Week 120 | 80.0 | — |
| Treatment - Week 126 | 100 | — |
| Treatment - Week 132 | 100 | — |
| Treatment - Week 138 | 100 | — |
Percentage of participants who filled out an ED-5D-5L questionnaire at a visit. EQ-5D-5L: A generic preference-based health utility measure that provides a single index value for health status. The instrument consists of two parts. The first part, health-state classification, contains five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
| percentage of participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Treatment - Week 0 | 88.9 | 82.9 |
| Treatment - Week 3 | 86.6 | 78.8 |
| Treatment - Week 6 | 91.9 | 58.6 |
| Treatment - Week 12 | 86.8 | 80 |
| Treatment - Week 18 | 72.1 | 66.7 |
| Treatment - Week 24 | 82.4 | 100 |
| Treatment - Week 30 | 80 | 66.7 |
| Treatment - Week 36 | 80 | 50 |
| Treatment - Week 42 | 91.7 | 50 |
| Treatment - Week 48 | 62.5 | 0 |
| Treatment - Week 54 | 100 | — |
| Treatment - Week 60 | 50 | — |
TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea \[single item and multi-item scales\] chest pain \[single item\], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-LC13.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Coughing score | 18.1 (7.2 to NA) | 16.6 (3.3 to 16.6) |
| Dyspnoea score | 4.1 (1.4 to 11.3) | 3.3 (1.0 to NA) |
| Pain in chest score | NA (11.1 to NA) | NA (1.6 to NA) |
| Pain in arm or shoulder score | 12.5 (7.4 to NA) | 1.9 (1.6 to NA) |
TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea \[single item and multi-item scales\] chest pain \[single item\], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-LC13.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Coughing score | NA (8.3 to NA) | 16.6 (1.2 to 16.6) |
| Dyspnoea score | 9.7 (1.5 to 14.4) | 1.4 (0.8 to NA) |
| Pain in chest score | NA (9.7 to NA) | NA (1.4 to NA) |
| Pain in arm or shoulder score | 11.1 (4.1 to NA) | 1.7 (0.9 to NA) |
TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea \[single item and multi-item scales\] chest pain \[single item\], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-C30.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Dyspnoea score | 13.3 (2.9 to NA) | 8.3 (1.2 to 8.3) |
| Fatigue score | 5.6 (1.4 to NA) | 1.2 (0.8 to NA) |
TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea \[single item and multi-item scales\] chest pain \[single item\], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-C30.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Dyspnoea score | 16.6 (2.9 to NA) | 8.3 (1.0 to 8.3) |
| Fatigue score | 14.4 (2.6 to NA) | 1.0 (0.8 to NA) |
TTD for a composite of three symptoms (cough, dyspnea, chest pain) in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for any component of the composite of the three following symptoms \[cough, dyspnea \[multi-item subscales QLQ-LC13\] and chest pain\]) as measured by the EORTC QLQ-LC13.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| TTD in Composite of Three Symptoms (Cough, Dyspnea, and Chest Pain) Using EORTC QLQ-LC13 Score for C-ITT Population | 2.8 (0.9 to 5.6) | 1.4 (0.8 to NA) |
TTD for a composite of three symptoms (cough, dyspnea, chest pain) in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for any component of the composite of the three following symptoms \[cough, dyspnea \[multi-item subscales QLQ-LC13\] and chest pain\]) as measured by the EORTC QLQ-LC13.
| months | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| TTD in Composite of Three Symptoms (Cough, Dyspnea, and Chest Pain) Using EORTC QLQ-LC13 Score for ITT Population | 1.4 (0.9 to 4.2) | 1.4 (0.9 to 4.2) |
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
| Percentage of Participants | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | 89.6 | 89.2 |
Collected over Approximately 15 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Alectinib | 26/77 (33.8%) | 20/77 (26%) | 57/77 (74%) |
| Active Comparator: Premetrexed/Docetaxel | 4/37 (10.8%) | 7/37 (18.9%) | 31/37 (83.8%) |
| Event | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/77 | 2/37 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/77 | 2/37 |
| PneumoniaInfections and infestations | 4/77 | 0/37 |
| NeutropeniaBlood and lymphatic system disorders | 0/77 | 1/37 |
| Abdominal painGastrointestinal disorders | 1/77 | 1/37 |
| DiarrhoeaGastrointestinal disorders | 0/77 | 1/37 |
| NauseaGastrointestinal disorders | 0/77 | 1/37 |
| StomatitisGastrointestinal disorders | 0/77 | 1/37 |
| Lung infectionInfections and infestations | 0/77 | 1/37 |
| Pneumonia bacterialInfections and infestations | 0/77 | 1/37 |
| Event | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel |
|---|---|---|
| FatigueGeneral disorders | 5/77 | 9/37 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/77 | 8/37 |
| ConstipationGastrointestinal disorders | 16/77 | 4/37 |
| NauseaGastrointestinal disorders | 3/77 | 6/37 |
| AstheniaGeneral disorders | 9/77 | 6/37 |
| AnaemiaBlood and lymphatic system disorders | 12/77 | 4/37 |
| Oedema peripheralGeneral disorders | 11/77 | 2/37 |
| MyalgiaMusculoskeletal and connective tissue disorders | 11/77 | 4/37 |
| Back painMusculoskeletal and connective tissue disorders | 10/77 | 2/37 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 9/77 | 0/37 |
Intent-to-treat (ITT) population included all participants randomized in the study, irrespective of whether or not they received study drug.
| Age, Continuous(years) | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel | Total |
|---|---|---|---|
| Mean | 54.6 ± 13.0 | 58.8 ± 10.5 | 56.0 ± 12.4 |
| Sex: Female, Male(Participants) | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel | Total |
|---|---|---|---|
| Female | 33 | 20 | 53 |
| Male | 46 | 20 | 66 |
| Race/Ethnicity, Customized(Participants) | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 4 | 9 |
| Not Hispanic or Latino | 68 | 34 | 102 |
| Not reported | 4 | 1 | 5 |
| Unknown | 0 | 1 | 1 |
| Missing | 2 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Experimental: Alectinib | Active Comparator: Premetrexed/Docetaxel | Total |
|---|---|---|---|
| White | 67 | 32 | 99 |
| Asian | 6 | 8 | 14 |
| Unknown | 5 | 0 | 5 |
| Native Hawaiian or other Pacific Islander | 1 | 0 | 1 |
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Hoffmann-La Roche