A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Conditions:Lung Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:August 16, 2018
End Date:August 13, 2026
Contact:Reference Study ID Number: BO40336 www.roche.com/about_roche/roche_worldwide.htm
Phone:888-662-6728 (U.S. and Canada)

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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

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.

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 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

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

- 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
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