NCT03155009

Brief Summary

This study will evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC), after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor, and eventually chemotherapy treatment(s).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2019

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

May 11, 2017

Last Update Submit

February 7, 2020

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), v.1.1. CR is defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to \<10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.

    Up to 2 years

Secondary Outcomes (12)

  • Central Nervous System Objective Response Rate (C-ORR)

    Up to 2 years

  • Progression-Free Survival (PFS)

    Up to 2 years

  • Time to Progression (TTP)

    Up to 2 years

  • Disease Control Rate (DCR)

    Up to 2 years

  • Duration of Response (DOR)

    Up to 2 years

  • +7 more secondary outcomes

Study Arms (1)

Alectinib

EXPERIMENTAL

600 mg orally twice daily (BID) for up to 2 years

Drug: Alectinib

Interventions

AlectinibDRUG

600 mg orally BID with food

Alectinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer \[AJCC\] classification)
  • Life expectancy of at least 12 weeks, in the opinion of the Investigator
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
  • Having contributive biopsy performed on fresh tissue (FFPE blocks required) taken after progression on previous therapy showing presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by immunohistochemistry (IHC) and confirmed by fluorescence in situ hybridization (FISH)
  • Absence of resistance mechanism to alectinib assessed by the Biomarkers Board
  • Disease progression, limited to central nervous system (CNS) without possibility of tissue biopsy
  • History of crizotinib exposure
  • Washout period: if previous progression on crizotinib: 7 days from last intake of the drug
  • If previous progression on chemotherapy: 28 days
  • If previous radiation therapy: 15 days
  • Participants must have recovered from treatment toxicities to ≤ Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease \[ILD\], they must have fully recovered)
  • Recovery from effects of any major surgery, or significant traumatic injury, at least 35 days before the first dose of alectinib
  • Adequate hematologic function
  • Adequate renal function
  • For all females of childbearing potential, a negative pregnancy test must be obtained within three days before starting study drug
  • +3 more criteria

You may not qualify if:

  • Prior therapy with other ALK inhibitors than crizotinib (including alectinib)
  • Participants with symptomatic CNS metastases who are neurologically unstable or require increasing doses of steroids within one week prior to Day 0 to manage CNS symptoms
  • Participants with progression limited to CNS and eligible to a focal treatment (surgery or stereotaxic radiotherapy)
  • Administration of strong/ potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug
  • Liver disease
  • 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 investigator, pose an unacceptable risk to the participant in this study
  • Active or uncontrolled infectious diseases requiring treatment
  • History of organ transplant
  • Participants with baseline QTc \> 470 ms or participants with symptomatic bradycardia
  • Pregnant or lactating women
  • History of hypersensitivity to any of the additives in the alectinib drug
  • 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 participant before trial entry
  • Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

CHU Angers

Angers, 49933, France

Location

Hopital Jean Minjoz; Pneumologie

Besançon, 25030, France

Location

Hopital Augustin Morvan; Oncologie Thoracique

Brest, 29609, France

Location

Centre Francois Baclesse; Comite 3

Caen, 14076, France

Location

Centre Hospitalier Intercommunal; Service de Pneumologie

Créteil, 94010, France

Location

Hôpital Nord Michallon; Pneumologie

La Tronche, 38700, France

Location

CHRU Lille Service de Pneumologie et Oncologie Thoracique

Lille, 59000, France

Location

Hôpital Nord - AP-HM Marseille#

Marseille, 13915, France

Location

Hopital Emile Muller;Pneumologie

Mulhouse, 68070, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital Tenon;Pneumologie

Paris, 75970, France

Location

CHU de Bordeaux

Pessac, 33600, France

Location

Hopital de Pontchaillou; Service de Pneumologie

Rennes, 35033, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

Toulouse, 31100, France

Location

Hopital Robert Schuman; Pneumologie

Vantoux, 57070, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

alectinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 16, 2017

Study Start

July 10, 2017

Primary Completion

September 26, 2019

Study Completion

September 26, 2019

Last Updated

February 10, 2020

Record last verified: 2020-02

Locations

FR(16)