A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT02838420

Recruitment Status : Active, not recruiting

First Posted : July 20, 2016

Results First Posted : July 11, 2019

Last Update Posted : April 4, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
Interventions	Drug: Alectinib Drug: Crizotinib
Enrollment	187

Participant Flow

Recruitment Details	Asian adult participants with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) were enrolled at 21 study sites in 3 countries - China, Korea, and Thailand.
Pre-assignment Details


Arm/Group Title	Alectinib	Crizotinib
Arm/Group Description	Participants received alectinib cap...	Participants received crizotinib ca...
Arm/Group Description	Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Period Title: Overall Study
Started	125	62
Completed	0	0
Not Completed	125	62
Reason Not Completed
Ongoing in Study	113	45
Lost to Follow-up	1	0
Withdrawal by Subject	3	4
Death	8	13

Baseline Characteristics

Arm/Group Title		Alectinib	Crizotinib	Total
Arm/Group Description		Participants received alectinib cap...	Participants received crizotinib ca...	Total of all reporting groups
Arm/Group Description		Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.	Total of all reporting groups
Overall Number of Baseline Participants		125	62	187
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	125 participants	62 participants	187 participants
		50.5 (11.3)	51.1 (12.6)	50.7 (11.7)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	125 participants	62 participants	187 participants
	Female	61 48.8%	28 45.2%	89 47.6%
	Male	64 51.2%	34 54.8%	98 52.4%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	125 participants	62 participants	187 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	124 99.2%	60 96.8%	184 98.4%
	Unknown or Not Reported	1 0.8%	2 3.2%	3 1.6%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	125 participants	62 participants	187 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	125 100.0%	62 100.0%	187 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1
Description	PFS was defined as the time (in months) from randomization to the firs...
Description	PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by the investigators, or to death from any cause, whichever occurred first.
Time Frame	From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months)

Outcome Measure Data

Analysis Population Description

The primary analysis population for efficacy was the intent-to-treat (ITT) population, defined as all randomized participants.


Arm/Group Title	Alectinib	Crizotinib
Arm/Group Description:	Participants received alectinib cap...	Participants received crizotinib ca...
Arm/Group Description:	Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed	125	62
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (20.3 to NA)	11.1 (9.1 to 13.0)

[1]

Median and upper bound of 95% CI could not be estimated as PFS had not been reached at the time of data cutoff for the primary end point.

2.Secondary Outcome


Title	PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1
Description	PFS was defined as the time (in months) from randomization to the firs...
Description	PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by an independent review committee, or to death from any cause, whichever occurred first.
Time Frame	Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome Measure Data Not Reported

3.Secondary Outcome


Title	Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Using RECIST v1.1
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome Measure Data Not Reported

4.Secondary Outcome


Title	Time to Progression of Disease in the CNS as Determined by IRC Using RECIST v1.1
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome Measure Data Not Reported

5.Secondary Outcome


Title	Time to Progression of Disease in the CNS as Determined by IRC Using Response Assessment in Neuro-Oncology (RANO)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome Measure Data Not Reported

6.Secondary Outcome


Title	Duration of Response (DOR) Assessed by Investigator Using RECIST v1.1
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome Measure Data Not Reported

7.Secondary Outcome


Title	Overall Survival Time
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, until death (up to overall period of approximately 40 months)

Outcome Measure Data Not Reported

8.Secondary Outcome


Title	Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events
Description	An adverse event is any untoward medical occurrence in a participant a...
Description	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame	Up to overall period of approximately 40 months

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who received at least one dose of study drug.


Arm/Group Title	Alectinib	Crizotinib
Arm/Group Description:	Participants received alectinib cap...	Participants received crizotinib ca...
Arm/Group Description:	Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed	125	62
Measure Type: Number Unit of Measure: Percentage of Participants
Serious Adverse Events	15.2	25.8
Non-Serious Adverse Events	99.2	100.0

9.Secondary Outcome


Title	Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Core (QLQ-C30) Score
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome Measure Data Not Reported

10.Secondary Outcome


Title	Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer Module (QLQ-LC13) Score
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)

Outcome Measure Data Not Reported

11.Secondary Outcome


Title	Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite
Description	AUC was collected for both alectinib and its major metabolite, M4, and...
Description	AUC was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.
Time Frame	Baseline and Week 4 predose (within 2 hours before administration of study drug)

Outcome Measure Data

Analysis Population Description

The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.


Arm/Group Title	Alectinib	Crizotinib
Arm/Group Description:	Participants received alectinib cap...	Participants received crizotinib ca...
Arm/Group Description:	Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed	20	0
Mean (Standard Deviation) Unit of Measure: Hoursnanogram/milliliter (hrng/mL)
Alectinib Baseline	1590 (852)
M4 Baseline	471 (243)
Alectinib Week 4	7760 (3270)
M4 Week 4	2890 (1130)

12.Secondary Outcome


Title	Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite
Description	Cmax was collected for both alectinib and its major metabolite, M4, an...
Description	Cmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.
Time Frame	Baseline and Week 4 predose (within 2 hours before administration of study drug)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Alectinib	Crizotinib
Arm/Group Description:	Participants received alectinib cap...	Participants received crizotinib ca...
Arm/Group Description:	Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed	20	0
Mean (Standard Deviation) Unit of Measure: Nanograms/milliliter (ng/mL)
Alectinib Baseline	255 (130)
M4 Baseline	71.4 (33.5)
Alectinib Week 4	861 (332)
M4 Week 4	306 (111)

13.Secondary Outcome


Title	Time to Cmax (Tmax) of Alectinib and Its Metabolite
Description	Tmax was collected for both alectinib and its major metabolite, M4, an...
Description	Tmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.
Time Frame	Baseline and Week 4 predose (within 2 hours before administration of study drug)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Alectinib	Crizotinib
Arm/Group Description:	Participants received alectinib cap...	Participants received crizotinib ca...
Arm/Group Description:	Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Overall Number of Participants Analyzed	20	0
Mean (Standard Deviation) Unit of Measure: Hour (hr)
Alectinib Baseline	5.61 (3.02)
M4 Baseline	8.19 (2.30)
Alectinib Week 4	4.30 (2.45)
M4 Week 4	4.11 (3.06)

Adverse Events

Time Frame	Up to approximately 40 months
Adverse Event Reporting Description	The safety population was defined as all participants who received at least one dose of study drug. All participants in the ITT population received at least one dose of study drug and were included in the safety population.

Arm/Group Title	Alectinib	Crizotinib
Arm/Group Description	Participants received alectinib cap...	Participants received crizotinib ca...
Arm/Group Description	Participants received alectinib capsules orally at a dose of 600 mg twice a day (BID) with food until disease progression, unacceptable toxicity withdrawal of consent, or death.	Participants received crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity, withdrawal of consent, or death.
All-Cause Mortality
	Alectinib	Crizotinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	8/125 (6.40%)	13/62 (20.97%)
Serious Adverse Events Serious Adverse Events
	Alectinib	Crizotinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	19/125 (15.20%)	16/62 (25.81%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/125 (0.80%)	0/62 (0.00%)
Cardiac disorders
Bradycardia ^† 1	0/125 (0.00%)	2/62 (3.23%)
Pericardial effusion ^† 1	1/125 (0.80%)	0/62 (0.00%)
General disorders
Death ^† 1	1/125 (0.80%)	0/62 (0.00%)
Fatigue ^† 1	0/125 (0.00%)	1/62 (1.61%)
Pyrexia ^† 1	1/125 (0.80%)	0/62 (0.00%)
Hepatobiliary disorders
Hepatic function abnormal ^† 1	0/125 (0.00%)	2/62 (3.23%)
Drug-induced liver injury ^† 1	0/125 (0.00%)	1/62 (1.61%)
Infections and infestations
Lung infection ^† 1	1/125 (0.80%)	2/62 (3.23%)
Pneumonia ^† 1	1/125 (0.80%)	2/62 (3.23%)
Appendicitis ^† 1	0/125 (0.00%)	1/62 (1.61%)
Bronchitis ^† 1	1/125 (0.80%)	0/62 (0.00%)
Escherichia sepsis ^† 1	0/125 (0.00%)	1/62 (1.61%)
Upper respiratory tract infection ^† 1	1/125 (0.80%)	0/62 (0.00%)
Wound infection ^† 1	1/125 (0.80%)	0/62 (0.00%)
Injury, poisoning and procedural complications
Post procedural ooedema ^† 1	1/125 (0.80%)	0/62 (0.00%)
Rib fracture ^† 1	1/125 (0.80%)	0/62 (0.00%)
Wound dehiscence ^† 1	1/125 (0.80%)	0/62 (0.00%)
Investigations
Blood uric acid increased ^† 1	3/125 (2.40%)	1/62 (1.61%)
Blood creatine phosphokinase increased ^† 1	0/125 (0.00%)	2/62 (3.23%)
Alanine aminotransferase increased ^† 1	0/125 (0.00%)	1/62 (1.61%)
Blood bilirubin increased ^† 1	1/125 (0.80%)	0/62 (0.00%)
Metabolism and nutrition disorders
Hypokalaemia ^† 1	1/125 (0.80%)	0/62 (0.00%)
Nervous system disorders
Brain ooedema ^† 1	1/125 (0.80%)	0/62 (0.00%)
Cerebral infarction ^† 1	1/125 (0.80%)	0/62 (0.00%)
Intracranial pressure increased ^† 1	0/125 (0.00%)	1/62 (1.61%)
Paraplegia ^† 1	1/125 (0.80%)	0/62 (0.00%)
Spinal cord compression ^† 1	0/125 (0.00%)	1/62 (1.61%)
Psychiatric disorders
Suicide attempt ^† 1	1/125 (0.80%)	0/62 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/125 (0.80%)	0/62 (0.00%)
Reproductive system and breast disorders
Dysfunctional uterine bleeding ^† 1	0/125 (0.00%)	1/62 (1.61%)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease ^† 1	1/125 (0.80%)	3/62 (4.84%)
Dyspnoea ^† 1	1/125 (0.80%)	0/62 (0.00%)
Pleural effusion ^† 1	1/125 (0.80%)	0/62 (0.00%)
Pneumothorax ^† 1	1/125 (0.80%)	0/62 (0.00%)
Respiratory failure ^† 1	1/125 (0.80%)	0/62 (0.00%)
Surgical and medical procedures
Abortion induced ^† 1	1/125 (0.80%)	0/62 (0.00%)
Vascular disorders
Venous thrombosis ^† 1	0/125 (0.00%)	1/62 (1.61%)
1 Term from vocabulary, MedDRA version 21.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Alectinib	Crizotinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	124/125 (99.20%)	62/62 (100.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	38/125 (30.40%)	14/62 (22.58%)
Neutropenia ^† 1	0/125 (0.00%)	5/62 (8.06%)
Cardiac disorders
Sinus bradycardia ^† 1	37/125 (29.60%)	11/62 (17.74%)
Bradycardia ^† 1	12/125 (9.60%)	5/62 (8.06%)
Eye disorders
Vision blurred ^† 1	2/125 (1.60%)	9/62 (14.52%)
Gastrointestinal disorders
Constipation ^† 1	45/125 (36.00%)	31/62 (50.00%)
Diarrhoea ^† 1	16/125 (12.80%)	31/62 (50.00%)
Nausea ^† 1	8/125 (6.40%)	21/62 (33.87%)
Vomiting ^† 1	7/125 (5.60%)	22/62 (35.48%)
General disorders
Fatigue ^† 1	11/125 (8.80%)	9/62 (14.52%)
Pyrexia ^† 1	11/125 (8.80%)	9/62 (14.52%)
Chest pain ^† 1	10/125 (8.00%)	8/62 (12.90%)
Oedema peripheral ^† 1	8/125 (6.40%)	10/62 (16.13%)
Chest discomfort ^† 1	10/125 (8.00%)	3/62 (4.84%)
Asthenia ^† 1	6/125 (4.80%)	5/62 (8.06%)
Oedema ^† 1	9/125 (7.20%)	2/62 (3.23%)
Hepatobiliary disorders
Liver injury ^† 1	14/125 (11.20%)	4/62 (6.45%)
Hepatic function abnormal ^† 1	9/125 (7.20%)	4/62 (6.45%)
Infections and infestations
Upper respiratory tract infection ^† 1	23/125 (18.40%)	6/62 (9.68%)
Nasopharyngitis ^† 1	15/125 (12.00%)	3/62 (4.84%)
Urinary tract infection ^† 1	8/125 (6.40%)	1/62 (1.61%)
Lung infection ^† 1	2/125 (1.60%)	4/62 (6.45%)
Investigations
Aspartate aminotransferase increased ^† 1	65/125 (52.00%)	31/62 (50.00%)
Alanine aminotransferase increased ^† 1	52/125 (41.60%)	34/62 (54.84%)
Blood creatine phosphokinase increased ^† 1	55/125 (44.00%)	18/62 (29.03%)
Blood bilirubin increased ^† 1	61/125 (48.80%)	2/62 (3.23%)
Blood alkaline phosphatase increased ^† 1	33/125 (26.40%)	8/62 (12.90%)
Blood creatinine increased ^† 1	25/125 (20.00%)	15/62 (24.19%)
Bilirubin conjugated increased ^† 1	33/125 (26.40%)	2/62 (3.23%)
Weight increased ^† 1	23/125 (18.40%)	2/62 (3.23%)
Gamma-glutamyltransferase increased ^† 1	5/125 (4.00%)	17/62 (27.42%)
Haemoglobin decreased ^† 1	18/125 (14.40%)	3/62 (4.84%)
White blood cell count decreased ^† 1	6/125 (4.80%)	15/62 (24.19%)
Blood lactate dehydrogenase increased ^† 1	11/125 (8.80%)	7/62 (11.29%)
Neutrophil count decreased ^† 1	4/125 (3.20%)	12/62 (19.35%)
Blood bilirubin unconjugated increased ^† 1	14/125 (11.20%)	0/62 (0.00%)
Blood thyroid stimulating hormone increased ^† 1	12/125 (9.60%)	1/62 (1.61%)
Electrocardiogram QT prolonged ^† 1	4/125 (3.20%)	7/62 (11.29%)
Blood albumin decreased ^† 1	4/125 (3.20%)	5/62 (8.06%)
Blood creatine phosphokinase MB increased ^† 1	4/125 (3.20%)	5/62 (8.06%)
Weight decreased ^† 1	1/125 (0.80%)	5/62 (8.06%)
Protein total decreased ^† 1	0/125 (0.00%)	4/62 (6.45%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	6/125 (4.80%)	22/62 (35.48%)
Hypoalbuminaemia ^† 1	6/125 (4.80%)	8/62 (12.90%)
Hypokalaemia ^† 1	10/125 (8.00%)	4/62 (6.45%)
Hyponatraemia ^† 1	4/125 (3.20%)	9/62 (14.52%)
Hypoproteinaemia ^† 1	1/125 (0.80%)	4/62 (6.45%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	11/125 (8.80%)	10/62 (16.13%)
Musculoskeletal pain ^† 1	12/125 (9.60%)	3/62 (4.84%)
Pain in extremity ^† 1	9/125 (7.20%)	6/62 (9.68%)
Myalgia ^† 1	11/125 (8.80%)	2/62 (3.23%)
Nervous system disorders
Dizziness ^† 1	7/125 (5.60%)	13/62 (20.97%)
Headache ^† 1	7/125 (5.60%)	10/62 (16.13%)
Dysgeusia ^† 1	1/125 (0.80%)	10/62 (16.13%)
Psychiatric disorders
Insomnia ^† 1	7/125 (5.60%)	6/62 (9.68%)
Renal and urinary disorders
Haematuria ^† 1	8/125 (6.40%)	1/62 (1.61%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	27/125 (21.60%)	11/62 (17.74%)
Dyspnoea ^† 1	12/125 (9.60%)	5/62 (8.06%)
Productive cough ^† 1	7/125 (5.60%)	3/62 (4.84%)
Skin and subcutaneous tissue disorders
Rash ^† 1	21/125 (16.80%)	3/62 (4.84%)
Pruritis ^† 1	12/125 (9.60%)	5/62 (8.06%)
1 Term from vocabulary, MedDRA version 21.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Communications
Organization:	Hoffmann-La Roche
Phone:	800-821-8590
EMail:	genentech@druginfo.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zhou C, Kim SW, Reungwetwattana T, Zhou J, Zhang Y, He J, Yang JJ, Cheng Y, Lee SH, Bu L, Xu T, Yang L, Wang C, Liu T, Morcos PN, Lu Y, Zhang L. Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomised phase 3 study. Lancet Respir Med. 2019 May;7(5):437-446. doi: 10.1016/S2213-2600(19)30053-0. Epub 2019 Apr 10.

Layout table for additonal information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT02838420
Other Study ID Numbers:	YO29449
First Submitted:	July 18, 2016
First Posted:	July 20, 2016
Results First Submitted:	May 29, 2019
Results First Posted:	July 11, 2019
Last Update Posted:	April 4, 2024

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