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A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Alectinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic NSCLC
  • ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test
  • NSCLC that has failed crizotinib treatment
  • Measurable disease as defined by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2
  • Adequate hematologic, hepatic and renal function

Exclusion Criteria:

  • Prior therapy with ALK inhibitor other than crizotinib
  • Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment
  • History of serious cardiac dysfunction
  • History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
  • Clinically significant gastrointestinal abnormality that would affect absorption of the drug
  • Pregnant or lactating women

Sites / Locations

  • University of Alabama at Birmingham
  • University of California Irvine
  • UCSD Moores Cancer Center
  • Loma Linda Cancer Center
  • UCLA
  • Univ of Colorado Canc Ctr
  • National Jewish Health
  • Lynn Regional Cancer Center West
  • Florida Hospital Cancer Inst
  • UF Health Orlando
  • H. Lee Moffitt Cancer Center and Research Inst.
  • University of Illinois Cancer Center
  • Monroe Medical Associates; Ingalls Memorial Hosp
  • Massachussets General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Can Ins
  • Newton-Wellesley Hospital
  • St. Joseph Mercy Hospital; Cancer Care Center.
  • Wayne State Uni ; Karmanos Cancer Center
  • Hackensack Univ Med Ctr
  • Roswell Park Cancer Inst.
  • Memorial Sloan-Kettering Cancer Center
  • Richmond University Medical Center; Pharmacy Department
  • Wake Forest University Health Sciences
  • Gabrail Cancer Center
  • The Ohio State University Comprehensive Cancer Center
  • Providence Portland Med Ctr
  • Oregon Health & Science Uni
  • St. Luke's Hospital; Pharmacy Department
  • Penn State Hershey Cancer Institute
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Pavillion
  • MUSC Hollings Cancer Center
  • Center for Biomedical Research LLC
  • Texas Oncology-Baylor Sammons Cancer Center
  • MD Anderson Cancer Center
  • Virginia Cancer Specialists, PC
  • Swedish Cancer Inst.
  • University of Wisconsin
  • Cross Cancer Institute
  • Lakeridge Health Oshawa; Oncology
  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Alectinib: Phase I (Dose Escalation)

Alectinib (Phase II: RP2 dose)

Arm Description

Participants will receive escalating doses of alectinib capsules orally until disease progression, death or withdrawal for any other reasons.

Participants will receive recommended Phase II dose as determined from Phase I until disease progression, death or withdrawal for any other reasons.

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities (DLTs): Phase I
The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of >=7 days which the Investigator could not rule out as been related to alectinib.
Recommended Phase II Dose (RP2D): Phase I
RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II
Percentage of participants with objective response as assessed by IRC was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).

Secondary Outcome Measures

Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I
Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.
Duration of Response (DOR) According to RECIST v1.1 by Investigator: Phase I
DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.
Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II
Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.
Percentage of Participants With Disease Control According to RECIST v1.1 by Investigator: Phase II
Disease control rate assessed according to RECIST v1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. 95% CI for rate was constructed using Clopper-Pearson method.
Percentage of Participants With Disease Progression According to RECIST v1.1 by IRC or Death : Phase II
Percentage of participants with disease progression according to RECIST v1.1 by IRC is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Progression-Free Survival (PFS) According to RECIST v1.1 by IRC: Phase II
PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Percentage of Participants With Disease Progression According to RECIST v1.1 by Investigator or Death : Phase II
Percentage of participants with disease progression according to RECIST v1.1 by investigator is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
PFS According to RECIST v1.1 by Investigator: Phase II
PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Percentage of Participants Who Died Due to Any Cause: Phase II
Overall Survival (OS) Time: Phase II
OS was defined as the time between date of first dose and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants without any follow-up information were censored at the date of first dose. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
DOR According to RECIST v1.1 by IRC: Phase II
DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
DOR According to RECIST v1.1 by Investigator: Phase II
DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Percentage of Participants With Central Nervous System Objective Response (COR) According to RECIST v1.1 by IRC: Phase II
COR rate (CORR) was defined as the percentage of participants who had a CR or PR of the baseline central nervous system (CNS) lesions, based on RECIST v.1.1. CNS responses according to RECIST v1.1 did not have to be confirmed. CR was defined as disappearance of all CNS lesions. PR was defined as >=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). 95% CI was computed using the Clopper-Pearson method.
Percentage of Participants With COR According to Response Assessment in Neuro-Oncology (RANO) Criteria by IRC: Phase II
CORR was defined as the percentage of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper-Pearson method was used to calculate 95% CI.
CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II
CDOR was defined for CNS responders as the time from the first observation of a CNS response of CR or PR until first observation of CNS progression or death from any cause. An analysis by IRC using RECIST v1.1 was performed. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. CR was defined as disappearance of all CNS lesions. PR was defined as >=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
CDOR According to RANO Criteria by IRC: Phase II
CDOR was defined as the time from the first observation of a CNS response of CR or PR according to RANO criteria until first observation of CNS progression or death from any cause. An analysis by RANO criteria was performed. Definitions of CR or PR as per RANO was included in description of Outcome Measure 17. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease) and clear worsening of neurological status with respect to the previous timepoint. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II
CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST v1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Percentage of Participants With CNS Progression According to RANO Criteria by IRC: Phase II
CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RANO criteria. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease).
Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I
Cmax After Multiple Dose of Alectinib: Phase I
Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I
AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf).
AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I
Ctrough After Multiple Dose of Alectinib: Phase II
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II
EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below (e.g. Global health status/QoL [quality of life]) represents absolute data at baseline. QoL=quality of life
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II
EORTC QLQ-LC13 consisted of 13 questions for dyspnea (3 items) and 10 single items (cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain). Questions used 4-point scale (1 'Not at all' to 4 'Very much'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below represents absolute data at baseline.

Full Information

First Posted
May 28, 2013
Last Updated
July 23, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01871805
Brief Title
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated With Crizotinib
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2013 (Actual)
Primary Completion Date
October 24, 2014 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of alectinib in participants with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alectinib: Phase I (Dose Escalation)
Arm Type
Experimental
Arm Description
Participants will receive escalating doses of alectinib capsules orally until disease progression, death or withdrawal for any other reasons.
Arm Title
Alectinib (Phase II: RP2 dose)
Arm Type
Experimental
Arm Description
Participants will receive recommended Phase II dose as determined from Phase I until disease progression, death or withdrawal for any other reasons.
Intervention Type
Drug
Intervention Name(s)
Alectinib
Other Intervention Name(s)
CH5424802, RO5424802
Intervention Description
Participants will receive alectinib as described in the arm descriptions.
Primary Outcome Measure Information:
Title
Number of Participants With Dose Limiting Toxicities (DLTs): Phase I
Description
The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of >=7 days which the Investigator could not rule out as been related to alectinib.
Time Frame
Throughout Cycle 1 of Phase I (21 days)
Title
Recommended Phase II Dose (RP2D): Phase I
Description
RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.
Time Frame
Throughout Cycle 1 of Phase I (21 days)
Title
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II
Description
Percentage of participants with objective response as assessed by IRC was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).
Time Frame
Cycle 1 Day 1 up to 194 weeks (assessed at every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter) (1 cycle = 21 days)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I
Description
Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Duration of Response (DOR) According to RECIST v1.1 by Investigator: Phase I
Description
DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II
Description
Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants With Disease Control According to RECIST v1.1 by Investigator: Phase II
Description
Disease control rate assessed according to RECIST v1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. 95% CI for rate was constructed using Clopper-Pearson method.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants With Disease Progression According to RECIST v1.1 by IRC or Death : Phase II
Description
Percentage of participants with disease progression according to RECIST v1.1 by IRC is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Progression-Free Survival (PFS) According to RECIST v1.1 by IRC: Phase II
Description
PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants With Disease Progression According to RECIST v1.1 by Investigator or Death : Phase II
Description
Percentage of participants with disease progression according to RECIST v1.1 by investigator is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
PFS According to RECIST v1.1 by Investigator: Phase II
Description
PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants Who Died Due to Any Cause: Phase II
Time Frame
Baseline up to death (any cause) (maximum follow up 284 weeks)
Title
Overall Survival (OS) Time: Phase II
Description
OS was defined as the time between date of first dose and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants without any follow-up information were censored at the date of first dose. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Time Frame
Baseline up to death (any cause) (maximum follow up 284 weeks)
Title
DOR According to RECIST v1.1 by IRC: Phase II
Description
DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
DOR According to RECIST v1.1 by Investigator: Phase II
Description
DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants With Central Nervous System Objective Response (COR) According to RECIST v1.1 by IRC: Phase II
Description
COR rate (CORR) was defined as the percentage of participants who had a CR or PR of the baseline central nervous system (CNS) lesions, based on RECIST v.1.1. CNS responses according to RECIST v1.1 did not have to be confirmed. CR was defined as disappearance of all CNS lesions. PR was defined as >=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). 95% CI was computed using the Clopper-Pearson method.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants With COR According to Response Assessment in Neuro-Oncology (RANO) Criteria by IRC: Phase II
Description
CORR was defined as the percentage of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper-Pearson method was used to calculate 95% CI.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II
Description
CDOR was defined for CNS responders as the time from the first observation of a CNS response of CR or PR until first observation of CNS progression or death from any cause. An analysis by IRC using RECIST v1.1 was performed. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. CR was defined as disappearance of all CNS lesions. PR was defined as >=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
CDOR According to RANO Criteria by IRC: Phase II
Description
CDOR was defined as the time from the first observation of a CNS response of CR or PR according to RANO criteria until first observation of CNS progression or death from any cause. An analysis by RANO criteria was performed. Definitions of CR or PR as per RANO was included in description of Outcome Measure 17. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease) and clear worsening of neurological status with respect to the previous timepoint. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II
Description
CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST v1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Percentage of Participants With CNS Progression According to RANO Criteria by IRC: Phase II
Description
CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RANO criteria. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease).
Time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
Title
Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I
Time Frame
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)
Title
Cmax After Multiple Dose of Alectinib: Phase I
Time Frame
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)
Title
Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I
Description
AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf).
Time Frame
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)
Title
AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I
Time Frame
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)
Title
Ctrough After Multiple Dose of Alectinib: Phase II
Time Frame
Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5 (1 cycle = 21 days)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II
Description
EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below (e.g. Global health status/QoL [quality of life]) represents absolute data at baseline. QoL=quality of life
Time Frame
Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)
Title
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II
Description
EORTC QLQ-LC13 consisted of 13 questions for dyspnea (3 items) and 10 single items (cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain). Questions used 4-point scale (1 'Not at all' to 4 'Very much'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below represents absolute data at baseline.
Time Frame
Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic NSCLC ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test NSCLC that has failed crizotinib treatment Measurable disease as defined by RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2 Adequate hematologic, hepatic and renal function Exclusion Criteria: Prior therapy with ALK inhibitor other than crizotinib Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment History of serious cardiac dysfunction History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) Clinically significant gastrointestinal abnormality that would affect absorption of the drug Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Loma Linda Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univ of Colorado Canc Ctr
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Lynn Regional Cancer Center West
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Florida Hospital Cancer Inst
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
UF Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Inst.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Monroe Medical Associates; Ingalls Memorial Hosp
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Massachussets General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Can Ins
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
St. Joseph Mercy Hospital; Cancer Care Center.
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Wayne State Uni ; Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hackensack Univ Med Ctr
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Inst.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Richmond University Medical Center; Pharmacy Department
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence Portland Med Ctr
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health & Science Uni
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's Hospital; Pharmacy Department
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Penn State Hershey Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Pavillion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
MUSC Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Center for Biomedical Research LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Oncology-Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Swedish Cancer Inst.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Lakeridge Health Oshawa; Oncology
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32009824
Citation
Gadgeel S, Shaw AT, Barlesi F, Crino L, Yang JC, Dingemans AM, Kim DW, de Marinis F, Schulz M, Liu S, Gupta R, Smoljanovic V, Ou SI. Time To Response In Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small-Cell Lung Cancer (NSCLC) Receiving Alectinib In The Phase II NP28673 And NP28761 Studies. Lung Cancer (Auckl). 2019 Nov 13;10:125-130. doi: 10.2147/LCTT.S209231. eCollection 2019.
Results Reference
derived
PubMed Identifier
31706099
Citation
Ou SI, Gadgeel SM, Barlesi F, Yang JC, De Petris L, Kim DW, Govindan R, Dingemans AM, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Mitry E, Muller B, Bordogna W, Balas B, Morcos PN, Shaw AT. Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020 Jan;139:22-27. doi: 10.1016/j.lungcan.2019.10.015. Epub 2019 Oct 14.
Results Reference
derived
PubMed Identifier
29748847
Citation
Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.
Results Reference
derived
PubMed Identifier
27863201
Citation
Gadgeel SM, Shaw AT, Govindan R, Gandhi L, Socinski MA, Camidge DR, De Petris L, Kim DW, Chiappori A, Moro-Sibilot DL, Duruisseaux M, Crino L, De Pas T, Dansin E, Tessmer A, Yang JC, Han JY, Bordogna W, Golding S, Zeaiter A, Ou SI. Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Dec;34(34):4079-4085. doi: 10.1200/JCO.2016.68.4639. Epub 2016 Oct 31. Erratum In: J Clin Oncol. 2017 May 10;35(14):1631.
Results Reference
derived
PubMed Identifier
27130468
Citation
Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.
Results Reference
derived
PubMed Identifier
26708155
Citation
Shaw AT, Gandhi L, Gadgeel S, Riely GJ, Cetnar J, West H, Camidge DR, Socinski MA, Chiappori A, Mekhail T, Chao BH, Borghaei H, Gold KA, Zeaiter A, Bordogna W, Balas B, Puig O, Henschel V, Ou SI; study investigators. Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol. 2016 Feb;17(2):234-242. doi: 10.1016/S1470-2045(15)00488-X. Epub 2015 Dec 19. Erratum In: Lancet Oncol. 2017 Mar;18(3):e134.
Results Reference
derived
PubMed Identifier
25153538
Citation
Gadgeel SM, Gandhi L, Riely GJ, Chiappori AA, West HL, Azada MC, Morcos PN, Lee RM, Garcia L, Yu L, Boisserie F, Di Laurenzio L, Golding S, Sato J, Yokoyama S, Tanaka T, Ou SH. Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol. 2014 Sep;15(10):1119-28. doi: 10.1016/S1470-2045(14)70362-6. Epub 2014 Aug 18.
Results Reference
derived

Learn more about this trial

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

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