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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03456076




Registration number
NCT03456076
Ethics application status
Date submitted
6/03/2018
Date registered
6/03/2018
Date last updated
29/01/2019

Titles & IDs
Public title
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
Scientific title
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2017-004331-37
Secondary ID [2] 0 0
BO40336
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alectnib
Treatment: Drugs - Cisplatin
Treatment: Drugs - Vinorelbine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin

Experimental: Alectinib -

Active Comparator: Platinum-Based Chemotherapy -


Treatment: Drugs: Alectnib
Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Treatment: Drugs: Cisplatin
Participants will receive Cisplatin 75 milligrams per square meter (mg/m^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."

Treatment: Drugs: Vinorelbine
Participants will receive Vinorelbine 25 mg/m^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.

Treatment: Drugs: Gemcitabine
Participants will receive Gemcitabine 1250 mg/m^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.

Treatment: Drugs: Pemetrexed
Participants will receive 500 mg/m^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."

Treatment: Drugs: Carboplatin
For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival (DFS), as Assessed by the Investigator - DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
Timepoint [1] 0 0
From the date of randomization until the first DFS event, up to approximately 5 years
Secondary outcome [1] 0 0
Overall Survival (OS) - Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI.
OS, defined as the time from randomization to death from any cause.
Timepoint [1] 0 0
From the date of randomization until death due to any cause up to approximately 8 years
Secondary outcome [2] 0 0
Plasma Concentration of Alectinib
Timepoint [2] 0 0
Predose (2 hours) at Baseline, Week 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, and 96
Secondary outcome [3] 0 0
Plasma Concentration of Alectinib metabolite
Timepoint [3] 0 0
Predose (2 hours) at Baseline, Week 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, and 96
Secondary outcome [4] 0 0
Percentage of Participants with Adverse Advent - Incidence of Adverse Events, with Severity Determined Through Use of National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 Safety Laboratory Values, Vital Signs, ECG
Timepoint [4] 0 0
From the date of randomization up to approximately 2 years

Eligibility
Key inclusion criteria
Key Inclusion Criteria

- Age =18 years

- Complete resection of histologically confirmed Stage IB (tumor = 4 cm) to Stage IIIA
(T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per Union Internationale Contre le
Cancer / American Joint Committee on Cancer, 7th edition, with negative margins, at
4-12 weeks before enrollment

- If mediastinoscopy was not performed preoperatively, it is expected that, at a
minimum, mediastinal lymph node systematic sampling will have occurred

- Documented ALK-positive disease according to an FDA-approved and CE-marked test

- Eligible to receive a platinum-based chemotherapy regimen according to the local
labels or guidelines

- Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1

- Adequate hematologic and renal function

- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods with a failure rate of < 1% per year during the treatment period
and for at least 90 days after the last dose of alectinib or according to local labels
or guidelines for chemotherapy

- For men: agreement to remain abstinent or use contraceptive measures, and agreement to
refrain from donating sperm for at least 90 days after the last dose of alectinib or
according to local labels or guidelines for chemotherapy. Men must refrain from
donating sperm during this same period

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Pregnant or breastfeeding, or intending to become pregnant during the study or within
90 days after the last dose of alectinib or according to local labels or guidelines
for chemotherapy

- Prior adjuvant radiotherapy for NSCLC

- Prior exposure to systemic chemotherapy and ALK inhibitors

- Stage IIIA N2 patients that, in the investigator's opinion, should receive
post-operative radiotherapy treatment are excluded from the study

- Known sensitivity to any component of study drug to which the patient may be
randomized. This includes, but is not limited to, patients with galactose intolerance,
a congenital lactase deficiency or glucose-galactose malabsorption.

- Malignancies other than NSCLC within 5 years prior to enrollment, except for
curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI)
cancer by endoscopic resection, in situ carcinoma of the cervix, ductal carcinoma in
situ, papillary thyroid cancer, or any cured cancer that is considered to have no
impact on disease free survival or overall survival for the current NSCLC

- Any GI disorder that may affect absorption of oral medications, such as malabsorption
syndrome or status post-major bowel resection

- Liver disease characterized by aspartate transaminase and alanine transaminase >= 3 ×
upper limit of normal or impaired excretory function or synthetic function or other
conditions of decompensated liver disease such as coagulopathy, hepatic
encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices or acute
viral or active autoimmune, alcoholic, or other types of acute hepatitis

- Japanese patients participating in the serial/intensive PK sample collection only:
administration of strong/potent CYP450 3A inhibitors or inducers within 14 days prior
to the first dose of study treatment and while on treatment with alectinib up to Week
3

- Any exclusion criteria based on the local labels or guidelines for chemotherapy
regimen

- Patients with symptomatic bradycardia

- History of organ transplant

- Known HIV positivity or AIDS-related illness

- Any clinically significant concomitant disease or condition that could interfere
with-or for which the treatment might interfere with the conduct of the study or the
absorption of oral medications or that would pose an unacceptable risk to the patients
in this study, in the opinion of the Principal Investigator

- Any psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol requirements and/or follow-up procedures;
those conditions should be discussed with the patient before trial entry

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [3] 0 0
Townsville Hospital - Townsville
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4810 - Townsville
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Austria
State/province [5] 0 0
Wels
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Bosnia and Herzegovina
State/province [7] 0 0
Banja Luka
Country [8] 0 0
Bosnia and Herzegovina
State/province [8] 0 0
Mostar
Country [9] 0 0
Bosnia and Herzegovina
State/province [9] 0 0
Sarajevo
Country [10] 0 0
Bosnia and Herzegovina
State/province [10] 0 0
Tuzla
Country [11] 0 0
China
State/province [11] 0 0
Anhui
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Changchun
Country [14] 0 0
China
State/province [14] 0 0
Guangzhou
Country [15] 0 0
China
State/province [15] 0 0
Hangzhou
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
China
State/province [17] 0 0
Shengyang
Country [18] 0 0
China
State/province [18] 0 0
Suzhou
Country [19] 0 0
Denmark
State/province [19] 0 0
Odense C
Country [20] 0 0
Egypt
State/province [20] 0 0
Cairo
Country [21] 0 0
France
State/province [21] 0 0
Angers
Country [22] 0 0
France
State/province [22] 0 0
Marseille
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
St Quentin
Country [26] 0 0
France
State/province [26] 0 0
Strasbourg
Country [27] 0 0
France
State/province [27] 0 0
Suresnes
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Chemnitz
Country [30] 0 0
Germany
State/province [30] 0 0
Georgsmarienhütte
Country [31] 0 0
Germany
State/province [31] 0 0
Heidelberg
Country [32] 0 0
Germany
State/province [32] 0 0
Immenhausen
Country [33] 0 0
Germany
State/province [33] 0 0
Lostau
Country [34] 0 0
Germany
State/province [34] 0 0
Paderborn
Country [35] 0 0
Greece
State/province [35] 0 0
Athens
Country [36] 0 0
Greece
State/province [36] 0 0
Thessaloniki
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Pecs
Country [39] 0 0
Hungary
State/province [39] 0 0
Szolnok
Country [40] 0 0
Israel
State/province [40] 0 0
Beer Sheva
Country [41] 0 0
Israel
State/province [41] 0 0
Haifa
Country [42] 0 0
Israel
State/province [42] 0 0
Kfar Saba
Country [43] 0 0
Israel
State/province [43] 0 0
Petach Tikva
Country [44] 0 0
Israel
State/province [44] 0 0
Ramat Gan
Country [45] 0 0
Italy
State/province [45] 0 0
Campania
Country [46] 0 0
Italy
State/province [46] 0 0
Emilia-Romagna
Country [47] 0 0
Italy
State/province [47] 0 0
Friuli-Venezia Giulia
Country [48] 0 0
Italy
State/province [48] 0 0
Lazio
Country [49] 0 0
Italy
State/province [49] 0 0
Lombardia
Country [50] 0 0
Italy
State/province [50] 0 0
Piemonte
Country [51] 0 0
Italy
State/province [51] 0 0
Toscana
Country [52] 0 0
Italy
State/province [52] 0 0
Umbria
Country [53] 0 0
Japan
State/province [53] 0 0
Aichi
Country [54] 0 0
Japan
State/province [54] 0 0
Chiba
Country [55] 0 0
Japan
State/province [55] 0 0
Ehime
Country [56] 0 0
Japan
State/province [56] 0 0
Fukuoka
Country [57] 0 0
Japan
State/province [57] 0 0
Hiroshima
Country [58] 0 0
Japan
State/province [58] 0 0
Hokkaido
Country [59] 0 0
Japan
State/province [59] 0 0
Hyogo
Country [60] 0 0
Japan
State/province [60] 0 0
Kanagawa
Country [61] 0 0
Japan
State/province [61] 0 0
Kumamoto
Country [62] 0 0
Japan
State/province [62] 0 0
Kyoto
Country [63] 0 0
Japan
State/province [63] 0 0
Miyagi
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Japan
State/province [64] 0 0
Niigata
Country [65] 0 0
Japan
State/province [65] 0 0
Okayama
Country [66] 0 0
Japan
State/province [66] 0 0
Osaka
Country [67] 0 0
Japan
State/province [67] 0 0
Saitama
Country [68] 0 0
Japan
State/province [68] 0 0
Shizuoka
Country [69] 0 0
Japan
State/province [69] 0 0
Tokyo
Country [70] 0 0
Japan
State/province [70] 0 0
Wakayama
Country [71] 0 0
Japan
State/province [71] 0 0
Yamaguchi
Country [72] 0 0
Kazakhstan
State/province [72] 0 0
Almaty
Country [73] 0 0
Kazakhstan
State/province [73] 0 0
Astana
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Gyeonggi-do
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Incheon
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Seoul
Country [77] 0 0
Latvia
State/province [77] 0 0
Riga
Country [78] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [78] 0 0
Skopje
Country [79] 0 0
Poland
State/province [79] 0 0
Gdansk
Country [80] 0 0
Poland
State/province [80] 0 0
Lublin
Country [81] 0 0
Poland
State/province [81] 0 0
Olsztyn
Country [82] 0 0
Poland
State/province [82] 0 0
Poznan
Country [83] 0 0
Poland
State/province [83] 0 0
Warszawa
Country [84] 0 0
Portugal
State/province [84] 0 0
Coimbra
Country [85] 0 0
Portugal
State/province [85] 0 0
Lisboa
Country [86] 0 0
Portugal
State/province [86] 0 0
Porto
Country [87] 0 0
Portugal
State/province [87] 0 0
Vila Nova De Gaia
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Moskovskaja Oblast
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Krasnodar
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Moscow
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Novosibirsk
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Obninsk
Country [93] 0 0
Russian Federation
State/province [93] 0 0
St. Petersburg
Country [94] 0 0
Saudi Arabia
State/province [94] 0 0
Riyadh
Country [95] 0 0
Singapore
State/province [95] 0 0
Singapore
Country [96] 0 0
South Africa
State/province [96] 0 0
Durban
Country [97] 0 0
Spain
State/province [97] 0 0
Barcelona
Country [98] 0 0
Spain
State/province [98] 0 0
Guipuzcoa
Country [99] 0 0
Spain
State/province [99] 0 0
La Coruña
Country [100] 0 0
Spain
State/province [100] 0 0
Madrid
Country [101] 0 0
Spain
State/province [101] 0 0
Malaga
Country [102] 0 0
Spain
State/province [102] 0 0
Sevilla
Country [103] 0 0
Spain
State/province [103] 0 0
Valencia
Country [104] 0 0
Taiwan
State/province [104] 0 0
Kaohsiung
Country [105] 0 0
Taiwan
State/province [105] 0 0
Taichung
Country [106] 0 0
Taiwan
State/province [106] 0 0
Tainan
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taipei
Country [108] 0 0
Taiwan
State/province [108] 0 0
Taoyuan
Country [109] 0 0
Thailand
State/province [109] 0 0
Bangkok
Country [110] 0 0
Thailand
State/province [110] 0 0
Chiangmai
Country [111] 0 0
Turkey
State/province [111] 0 0
Adana
Country [112] 0 0
Turkey
State/province [112] 0 0
Ankara
Country [113] 0 0
Turkey
State/province [113] 0 0
Istanbul
Country [114] 0 0
Turkey
State/province [114] 0 0
Izmir
Country [115] 0 0
Turkey
State/province [115] 0 0
Malatya
Country [116] 0 0
Turkey
State/province [116] 0 0
Samsun
Country [117] 0 0
Turkey
State/province [117] 0 0
Sihhiye, Ankara
Country [118] 0 0
Ukraine
State/province [118] 0 0
KIEV Governorate
Country [119] 0 0
Ukraine
State/province [119] 0 0
Dnipropetrovsk
Country [120] 0 0
Ukraine
State/province [120] 0 0
Kiev
Country [121] 0 0
Ukraine
State/province [121] 0 0
Kyiv
Country [122] 0 0
Ukraine
State/province [122] 0 0
Sumy
Country [123] 0 0
Ukraine
State/province [123] 0 0
Vinnytsia
Country [124] 0 0
Ukraine
State/province [124] 0 0
Zaporizhzhia
Country [125] 0 0
United Kingdom
State/province [125] 0 0
London
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Manchester
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to
investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant
setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice
daily (BID) taken with food for 24 months.

Participants in the control arm will receive one of the protocol specified platinum based
chemotherapy regimens for 4 cycles. Following treatment completion, participants will be
followed up for their disease until disease recurrence. At the time of disease recurrence,
participants will enter a survival follow-up until death, withdrawal of consent or study
closure, whichever occurs earlier.
Trial website
https://clinicaltrials.gov/show/NCT03456076
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO40336 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable