Clinical Trials /

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

NCT03456076

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Participants With ALK Positive Non-Small Cell Lung Cancer
  • Official Title: 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 Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: BO40336
  • SECONDARY ID: 2017-004331-37
  • NCT ID: NCT03456076

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
AlectnibRO5424802Alectinib
CisplatinPlatinum-Based Chemotherapy
VinorelbineNavelbinePlatinum-Based Chemotherapy
GemcitabineGitrabinPlatinum-Based Chemotherapy
PemetrexedAlimta®Platinum-Based Chemotherapy
CarboplatinPlatinum-Based Chemotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
AlectinibExperimental
  • Alectnib
Platinum-Based ChemotherapyActive Comparator
  • Cisplatin
  • Vinorelbine
  • Gemcitabine
  • Pemetrexed
  • Carboplatin

Eligibility Criteria

        Key Inclusion Criteria

          -  Complete resection of histologically confirmed Stage IB (tumor equal to or larger than
             4 centimeters) to Stage IIIA at 4-12 weeks before enrollment.

          -  Systematic lymph node sampling for patients for whom mediastinoscopy was not performed
             preoperatively.

          -  Documented anaplastic lymphoma kinase (ALK)-positive disease according to an
             FDA-approved test.

          -  Eligible to receive a platinum-based chemotherapy regimen according to the local
             labels.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of Grade 0 or 1.

          -  Adequate hematologic function, defined by laboratory test results, obtained within 3
             days prior to initiation of study treatment.

          -  Adequate renal function, defined by laboratory test results, obtained within 3 days
             prior to initiation of study treatment.

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive methods with a failure rate of superior
             or equal to 1% per year during the treatment period and for at least 90 days after the
             last dose of alectinib or according to local label for chemotherapy.

          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             contraceptive measures, and agreement to refrain from donating sperm.

        Key Exclusion Criteria 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 label
        for chemotherapy.

          -  Prior adjuvant radiotherapy for non-small cell lung cancer (NSCLC).

          -  Prior exposure to systemic chemotherapy.

          -  Prior exposure to ALK inhibitors.

          -  Malignancies other than NSCLC within 5 years prior to enrollment, except for
             curatively treated cancer as per exclusion criteria of the protocol.

          -  Any significant liver disease as defined by exclusion criteria.

          -  Participants with symptomatic bradycardia.

          -  History of organ transplant.

          -  Known HIV positivity or AIDS-related illness.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease-free Survival (DFS), as Assessed by the Investigator
Time Frame:Up to approximately 5 years
Safety Issue:
Description:DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Approximately 5 Years after First Patient In
Safety Issue:
Description:Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI. OS, defined as the time from randomization to death from any cause.
Measure:Plasma Concentration of Alectinib
Time Frame:Predose (2 hours) at Baseline, Week 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, and 96
Safety Issue:
Description:
Measure:Plasma Concentration of Alectinib metabolite
Time Frame:Predose (2 hours) at Baseline, Week 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, and 96
Safety Issue:
Description:
Measure:Percentage of Participants with Adverse Advent
Time Frame:Approximately 5 years after FPI
Safety Issue:
Description:Incidence of Adverse Events, with Severity Determined Through Use of National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 Safety Laboratory Values, Vital Signs, ECG

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hoffmann-La Roche

Trial Keywords

  • NSCLC, alectinib, ALK positive,adjuvant treatment, platinum based chemotherapy, complete resection, Stage IB-IIIA.

Last Updated

April 5, 2018