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Clinical Trials List

Protocol NumberBO40336
NCT Number(ClinicalTrials.gov Identfier)NCT03456076
Active

2018-08-01 - 2026-12-01

Phase III

Recruiting8

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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 ≥ 4 CM) TO STAGE IIIA ANAPLASTIC LYMPHOMA KINASE-POSITIVE NON-SMALL CELL LUNG CANCER

  • Trial Applicant

    Chugai Pharma Taiwan Ltd.

  • Sponsor

    F. Hoffmann-La Roche Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Chong-Jen Yu Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NON-SMALL CELL LUNG CANCER (NSCLC)

Objectives

This study will evaluate the efficacy and safety of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage IB (tumors ≥ 4 cm) to Stage IIIA, anaplastic lymphoma kinase−positive non−small cell lung cancer (NSCLC).

Test Drug

RO5424802(Alctinib)、capsule、 150mg

Active Ingredient

Alctinib

Dosage Form

Capsuule

Dosage

150

Endpoints

This study will evaluate the efficacy and safety of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage IB (tumors ≥ 4 cm) to Stage IIIA, anaplastic lymphoma kinase−positive non−small cell lung cancer (NSCLC).

Inclution Criteria

Inclusion Criteria
Patients must meet the following criteria for study entry:
• Signed Informed Consent Form
• Age ≥18 at time of signing Informed Consent Form
• 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 UICC/AJCC, 7th edition, with negative margins, at 4−12 weeks before enrollment
Accepted types of resection include any of the following: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.
Resection by segmentectomy or wedge resection is not allowed.
N3 disease is not allowed.
• If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred.
Systematic sampling is defined as removal of at least one representative lymph node at specified levels.
Complete mediastinal lymph node dissection (MLND) is preferred. MLND entails resection of all lymph nodes at those same levels.
For patients who have undergone a right thoracotomy, sampling or MLND is required at Levels 4 and 7; for those who have undergone a left thoracotomy, sampling or MLND is required at Levels 5 and/or 6 and 7.
Exceptions will be granted for the following situations:
If patients have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition), not all levels need to be sampled.
If the preoperative staging imaging results (contrast computed tomography [CT] and (Protocol Synopsis)
English Synopsis for KMUH, Version 1, 19Jun2020
Adapted on the basis of Protocol Synopsis of Protocol BO40336, Version 5, dated 26Nov2019 and Protocol
BO40336, Version 5, dated 26Nov2019
5 positron emission tomography scans) do not suggest evidence of disease in the mediastinum, the patient may be considered eligible even if N2 nodal sampling was not performed per surgeon’s decision.
• 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 (ECOG) Performance Status of Grade 0 or 1
• Adequate hematologic function, defined by the following laboratory test results, obtained
within 3 days prior to initiation of study treatment:
Platelet count ≥100 × 109/L
ANC ≥1500/μL
Hemoglobin > 9 g/dL
• Adequate renal function, defined by the following laboratory test results, obtained within
3 days prior to initiation of study treatment:
Serum creatinine≤ 1.5upper limit of normal (ULN) and
Creatinine clearance (CrCl) ≥ 60 mL/min
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) 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
A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to
surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).
Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method.
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are (Protocol Synopsis) English Synopsis for KMUH, Version 1, 19Jun2020
Adapted on the basis of Protocol Synopsis of Protocol BO40336, Version 5, dated 26Nov2019 and Protocol
BO40336, Version 5, dated 26Nov2019
6 not acceptable methods of contraception
Women of childbearing potential must have a negative serum pregnancy test results prior to randomization (maximum of −3 days) and within 10 days of the first dose of study drug. First dose of study drug (alectinib or chemotherapy) must be administered within 7 days from randomization.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in 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. Men must refrain from donating sperm during this same period.
With pregnant female partners, men must remain abstinent or use a condom 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 to avoid exposing the embryo.
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria

Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:
• 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
Radiotherapy in the neo-adjuvant setting is allowed and must be completed at least 4 weeks prior to initiation of study treatment.
• Prior exposure to systemic chemotherapy Chemotherapy for early-stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment, may be allowed upon approval (Protocol Synopsis) English Synopsis for KMUH, Version 1, 19Jun2020
Adapted on the basis of Protocol Synopsis of Protocol BO40336, Version 5, dated 26Nov2019 and Protocol BO40336, Version 5, dated 26Nov2019 7 by the Medical Monitor.
• Prior exposure to ALK inhibitors
• Stage IIIA N2 patients that, in the investigator's opinion, should receive PORT are excluded
from the study PORT is not allowed in the study.
• Known sensitivity to any component of study drug (alectinib or planned chemotherapy) 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 DFS or OS 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 any of the following:
ALT and AST ≥ 3 x ULN 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 Active viral or active autoimmune, alcoholic, or other types of acute hepatitis.
Active viral hepatitis B is defined as having positive hepatitis B surface antigen (HBsAg).
Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (hepatitis B core antibody [HBcAb] – HbcAb positive, but negative HBsAg) are eligible only if the HBV DNA test is negative.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
• 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 (Protocol Synopsis) English Synopsis for KMUH, Version 1, 19Jun2020
Adapted on the basis of Protocol Synopsis of Protocol BO40336, Version 5, dated 26Nov2019 and Protocol BO40336, Version 5, dated 26Nov2019 8
• Any exclusion criteria based on 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.

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    255 participants

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