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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Hoffmann-La Roche
Study ID
NCT03456076
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alectnib — DRUG
    Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
  • Cisplatin — DRUG
    Participants will receive Cisplatin 75 milligrams per square meter (mg/m\^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."
  • Vinorelbine — DRUG
    Participants will receive Vinorelbine 25 mg/m\^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
  • Gemcitabine — DRUG
    Participants will receive Gemcitabine 1250 mg/m\^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
  • Pemetrexed — DRUG
    Participants will receive 500 mg/m\^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."
  • Carboplatin — DRUG
    For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.

Study Details

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 Dates

Start date
Aug 16, 2018
Status verified
Apr 2026
Primary completion
Jun 26, 2023
Completion
Nov 19, 2031

Study Design

Enrollment
257 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alectinib
  • Active Comparator: Platinum-Based Chemotherapy

Primary Outcome Measure

Disease-free Survival (DFS), as Assessed by the Investigator [ Time Frame: Approximately 58 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-
MGH Cancer CenterBostonMassachusetts02114-
AHN Cancer Institute ? Allegheny General HospitalPittsburghPennsylvania15212-

Find similar trials in Chicago, IL

By research site
Rush University Medical Center· Chicago, ILMGH Cancer Center· Boston, MAAHN Cancer Institute ? Allegheny General Hospital· Pittsburgh, PA

Related Studies