A Study of Alectinib versus Pemetrexed or Docetaxel in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer

• Register: EUCTR
• Last refreshed on: 10 September 2018
• Main ID: EUCTR2015-000634-29-ES
• Date of registration: 10/07/2015
• Prospective Registration: Yes
• Primary sponsor: Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.
• Public title: A Study of Alectinib versus Pemetrexed or Docetaxel in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer
• Scientific title: RANDOMIZED, MULTICENTER, PHASE III, OPEN-LABEL STUDY OF ALECTINIB VERSUS PEMETREXED OR DOCETAXEL IN ANAPLASTIC LYMPHOMA KINASE-POSITIVE ADVANCED NON SMALL CELL LUNG CANCER PATIENTS PREVIOUSLY TREATED WITH PLATINUM-BASED CHEMOTHERAPY AND CRIZOTINIB
• Date of first enrolment: 07/08/2015
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000634-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Turkey

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive
- Patient had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib
- Prior CNS or leptomeningeal metastases allowed if asymptomatic.
- Patients with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
- Measurable disease (by Response Evaluation Criteria in Solid Tumors v1.1) prior to the administration of study treatment
- Age >=18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0?2
- Adequate hematologic and renal function
- Life expectancy of at least 12 weeks
- For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment
- For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug
- For men: agreement to 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 3 months after the last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion criteria:
-Patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection or in situ carcinoma of the cervix)
-Patients who have received any previous ALK inhibitor other than crizotinib
-Any GI disorder that may affect absorption of oral medications, such as mal-absorption syndrome or status post-major bowel resection
-Patients with liver disease
-National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
-History of organ transplant
-Patients with baseline QTc >470 milliseconds or symptomatic bradycardia
-Pregnant or lactating women
-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, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Anaplastic lymphoma kinase-positive (ALK-positive) non-small cell lung cancer (NSCLC)
MedDRA version: 18.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: Alectinib
Product Code: RO5424802
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Alectinib
Current Sponsor code: Ro542-4802/F03
Other descriptive name: ALK INHIBITOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: ALIMTA 500 mg powder for concentrate for solution for infusion
Product Name: ALIMTA
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: PEMETREXED
CAS Number: 137281-23-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Docetaxel-Actavis 20 mg/ml concentrate for solution for infusion
Product Name: Docetaxel-Actavis
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
CAS Number: 114977-28-5
Other descriptive name: DOCETAXEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: To evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS)

Timepoint(s) of evaluation of this end point: Up to 24 months

Primary end point(s): PFS as measured by investigator

Secondary Objective: ?To evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in patients with measurable CNS metastases at Baseline
?To evaluate and compare between treatment arms the PFS (by IRC);objective response rate (ORR); disease control rate (DCR) and duration of response (DOR) in all patients;time to CNS progression in all patients, CNS duration of response (C-DOR), CNS disease control rate (C-DCR) and C-ORR for all patients with baseline CNS metastasis, and overall survival (OS)
?To evaluate the safety and tolerability of alectinib compared with chemotherapy in all patients and patients with CNS metastases at Baseline
?To characterize the pharmacokinetics of alectinib and its major metabolite(s)
?To evaluate and compare time to deterioration (TTD) in patient-reported lung cancer symptoms
?To evaluate and compare patient-reported outcomes (PROs) of health-related quality of life (HRQoL) patient functioning and side effects of treatment

Secondary Outcome(s)

Secondary end point(s): 1. PFS by Independent Review Committee (IRC)
2. ORR and C-ORR
3. DCR and C-DCR
4. DOR and C-DOR
5. OS
6. Time to CNS progression
7. Incidence of adverse events and serious adverse events
8. Safety laboratory tests, Vital signs and ECG
9. Pharmacokinetics of alectinib and metabolite(s)
10. EORTC QLQ-C30 and EORTC QLQ-LC13 scores and the EuroQoL 5 Dimension (EQ-5D-5L) questionnaire score

Timepoint(s) of evaluation of this end point: 1-8. Up to 24 months
9. Pre-dose at Baseline, Week 3 and Week 6
10. Up to 24 months

Secondary ID(s)

2015-000634-29-PT

MO29750

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd