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

Phase 3

Active, not recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Alectnib; Drug: Cisplatin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Carboplatin

• Registration Number: NCT03456076
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-07
• Study Start: 2018-08-16
• Primary Completion: 2023-06-26
• Results First Submitted: 2024-06-18
• Results First Submitted QC: 2024-08-01
• Results First Posted: 2024-08-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Study Completion: 2026-11-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alectinib	Alectnib	-
Platinum-Based Chemotherapy	Cisplatin	-
Platinum-Based Chemotherapy	Gemcitabine	-
Platinum-Based Chemotherapy	Carboplatin	-
Platinum-Based Chemotherapy	Vinorelbine	-
Platinum-Based Chemotherapy	Pemetrexed	-

Primary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS), as Assessed by the Investigator	Approximately 58 months	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

Name	Time	Method
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms	Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Overall Survival (OS)	From the date of randomization until death due to any cause up to approximately 8 years	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.
Percentage of Participants With Adverse Events (AEs)	Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Plasma Concentration of Alectinib	Predose (2 hours) Week 3 - Week 96
Plasma Concentration of Alectinib Metabolite M4	Predose (2 hours) Week 3 - Week 96

Trial Locations

Locations (143)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

MGH Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Chris O'Brien Lifehouse; 🇦🇺 Camperdown, New South Wales, Australia

Northern Cancer Institute; 🇦🇺 St Leonards, New South Wales, Australia

Peter MacCallum Cancer Center; 🇦🇺 Melbourne, Victoria, Australia

Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie; 🇦🇹 Wien, Austria

Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?; 🇧🇾 Gomel, Homyel'skaya Voblasts', Belarus

Healthcare Institution Grodno University Hospital; Regional Oncologic Dispensary; 🇧🇾 Grodno, Hrodzyenskaya Voblasts', Belarus

Vitebsk Regional Clinical Oncology Dispensary; 🇧🇾 Vitebsk, Vitsyebskaya Voblasts', Belarus

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