Advanced or metastatic Non-small cell lung cancer (NSCLC) MedDRA version: 20.0 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) MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Alecensa
Product Name: Alectinib
Product Code: RO5424802/F03
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ALECTINIB
Other descriptive name: ALK INHIBITOR
Concentration unit: mg
Sponsors
Roche Farma S.A (Soc.Unipersonal) que realiza el ensayo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC - Age >=18 years - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 - Measurable disease (as defined by RECIST, v1.1) - Adequate recovery from most recent systemic or local treatment for cancer - Adequate organ function - Life expectancy >=12 weeks - For female patients of childbearing potential and male patients, willingness to use acceptable methods of contraception 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 284 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 284
Exclusion criteria
Exclusion criteria: - Inability to swallow oral medication - Women who are pregnant or lactating - Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments - History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, limited stage bladder cancer, Stage I uterine cancer, or other cancers from which the patient has been disease-free for at least 2 years -Significant cardiovascular disease -Known HIV positivity or AIDS-related illness -Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study -Inability to comply with other requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy of alectinib in patients with ALK/RET + advanced or metastatic NSCLC as determined by the blood somatic mutation profiling (bSMP) assay (Cohorts A and B) •To evaluate the efficacy of atezolizumab compared with platinum-based chemotherapy consisting of a platinum agent (cisplatin or carboplatin) in combination with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in chemotherapy-naive patients with inoperable Stage IIIB or Stage IV NSCLC in patients who are biomarker positive by the blood tumor mutational burden (bTMB) assay (Cohort C);Secondary Objective: •To evaluate the safety and tolerability of alectinib and atezolizumab (Cohorts A, B, and C) •To explore the pharmacokinetic (PK) characteristics of alectinib in RET+ patients (Cohort B) •To evaluate the impact of alectinib/ atezolizumab on patient-reported outcome (PROs);Primary end point(s): 1. Investigator-assessed ORR based on confirmed objective response (Cohorts A and B) 2. Investigator-assessed PFS according to RECIST v1.1 (Cohort C);Timepoint(s) of evaluation of this end point: 1-2. Up to 6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Investigator-assessed DOR, CBR, and PFS per RECIST v1.1 (Cohorts A and B) 2. IRF-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 (Cohorts A and B) 3. IRF-assessed PFS, ORR, and DOR according to RECIST v1.1 (Cohort C) 4. Investigator-assessed ORR, and DOR according to RECIST v1.1 (Cohort C) 5. OS (Cohorts A, B, and C) 6. Investigator-assessed PFS rates at 6-month and 1-year landmark timepoints (Cohort C) 7. Incidence, type, and severity of adverse events (based on the NCI CTCAE v4.0), including SAEs and AEs of special interest (Cohorts A, B, and C) 8. Changes in vital signs, physical findings, and clinical laboratory results during and following administration of protocol-specified IMPs (Cohorts A and B) 9. DLTs, if any, associated with alectinib at escalating doses in RET+ patients (Cohort B) 10. PK parameters of alectinib in RET+ patients (Cohort B) 11. Proportion of patients who improved compared with baseline in patient-reported lung cancer symptoms of cough, dyspnea, and chest pain and TTD as measured by SILC (Cohorts A, B, and C) 12. Mean change from baseline in HRQoL, patient functioning, and symptoms as measured by the EORTC QLQ-C30 (Cohorts A, B, and C) 13. Health status as assessed by the EQ-5D-5L questionnaire (Cohorts A, B, and C)) 14. Relationship between circulating biomarkers related to alectinib exposure and efficacy (Cohorts A and B);Timepoint(s) of evaluation of this end point: 1-5. Up to 6 years 6. At 6 month and 1 year 7-8. Up to 6 years 9. From Day 1 (D1) to D28 of Cycle 1 (C1) 10. Dose-Finding Phase: C1D1, C1D8, C2D1, C3D1, C4D1 Expansion Phase: C1D1, C2D1, C3D1, C4D1 11-14. Up to 6 years | — |
Countries
Australia, Belgium, Brazil, Canada, Chile, France, Germany, Hong Kong, Israel, Italy, Korea, Republic of, Mexico, Poland, Spain, Switzerland, Thailand, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd.
Outcome results
None listed