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Tyrosine Kinase Inhibitor

Alectinib vs Crizotinib for Non-Small Cell Lung Cancer (ALEX Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test

Eastern cooperative oncology group performance status (ECOG PS) of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and week 4; pre-dose (within 2 hours before alectinib) at week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)

Awards & highlights

ALEX Trial Summary

This trial is testing whether a new drug, alectinib, is better than the current standard of care, crizotinib, for people with treatment-naive ALK-positive advanced NSCLC. Participants will be given either drug BID until disease progression or unacceptable toxicity.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that tests positive for ALK, who haven't had treatment before. They should be generally healthy, not pregnant or breastfeeding, and willing to use effective contraception. People can't join if they've taken certain drugs recently, have serious health issues affecting the study or drug absorption, a history of severe allergies to trial drugs' ingredients, or other cancers within 3 years.Check my eligibility

What is being tested?

The study compares two oral medications: Alectinib (600 mg twice daily) versus Crizotinib (250 mg twice daily), in people with untreated ALK-positive advanced NSCLC. Participants are randomly assigned to one of these treatments until their disease worsens or they experience unacceptable side effects.See study design

What are the potential side effects?

Possible side effects include liver problems, digestive issues like nausea and diarrhea, vision disorders due to swelling in the retina for Alectinib users; heart rhythm changes especially QT prolongation for Crizotinib users; fatigue and potential allergic reactions.

ALEX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is advanced or has returned, and tests show it's ALK-positive.

Select...

I am able to get out of my bed or chair and move around.

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I have advanced lung cancer and haven't received any systemic treatment for it.

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I am not pregnant.

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My cancer can be measured using specific criteria before starting the study treatment.

ALEX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and week 4; pre-dose (within 2 hours before alectinib) at week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and week 4; pre-dose (within 2 hours before alectinib) at week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and week 4; pre-dose (within 2 hours before alectinib) at week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With PFS Event by Investigator Assessment

Progression-Free Survival (PFS) by Investigator Assessment

Secondary outcome measures

AUC of Alectinib Metabolite

Area Under The Concentration-Time Curve (AUC) of Alectinib

CNS DOR IRC-assessed According to RECIST v1.1 Criteria

+23 more

Side effects data

From 2018 Phase 3 trial • 119 Patients • NCT02604342

24%

Fatigue

22%

Alopecia

16%

Asthenia

16%

Nausea

11%

Neutropenia

11%

Myalgia

11%

Decreased appetite

11%

Anaemia

11%

Constipation

11%

Cough

Pruritus Generalised

Pyrexia

Paraesthesia

Arthralgia

Headache

Pain in extremity

Vomiting

Tinnitus

Febrile neutropenia

Musculoskeletal Chest Pain

Back pain

Diarrhoea

Dizziness

Drug Hypersensitivity

Oedema peripheral

Neuropathy peripheral

Gastroenteritis

Abdominal pain

Nasopharyngitis

Stomatitis

Upper Respiratory Tract Infection

Lung infection

Pneumonia bacterial

Bronchitis

100%

80%

60%

40%

20%

Study treatment Arm

Active Comparator: Premetrexed/Docetaxel

Experimental: Alectinib

ALEX Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AlectinibExperimental Treatment1 Intervention

Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Group II: CrizotinibActive Control1 Intervention

Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alectinib

2015

Completed Phase 3

~2400

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,830 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,547 Total Patients Enrolled

Media Library

Alectinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02075840 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Alectinib, Crizotinib

Non-Small Cell Lung Cancer Clinical Trial 2023: Alectinib Highlights & Side Effects. Trial Name: NCT02075840 — Phase 3

Alectinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02075840 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please provide a synopsis of the prior clinical trials that utilized Alectinib?

"Presently, there are 55 clinical trials dedicated to researching Alectinib. Out of those studies, 11 have reached the third phase. The majority of these research sites can be found in Westerville, Ohio; however, 8320 other locations across the globe are also running investigations into this medication."

Answered by AI

What potential risks have been associated with the use of Alectinib?

"According to our evaluations at Power, Alectinib has been assigned a rating of 3 on the safety scale. This is due to existing evidence that alludes to its efficacy and multiple studies demonstrating it's overall safety."

Answered by AI

At how many geographical sites is this investigation being conducted?

"The research initiative is presently being performed at 30 sites located in Orange, New york, Grand Junction and several other cities. To diminish the amount of travel necessary if a patient signs up, they should pick the location closest to them."

Answered by AI

How many participants have been accepted into this medical trial?

"Unfortunately, recruitment for this trial is no longer ongoing. It was first posted on August 19th 2014 and last updated December 2nd 2022. There are currently 2052 clinical trials searching for patients with non-small cell lung carcinoma (NSCLC) as well as 55 studies that involve Alectinib treatment actively recruiting participants."

Answered by AI

Is this experiment the inaugural of its type?

"Alectinib has been studied in 55 separate clinical trials across 65 countries and 1322 cities since its Phase 1 approval by Pfizer in 2011. To date, all of these studies have concluded their evaluations."

Answered by AI

Are there any vacancies in the research protocol for participants?

"This clinical trial has stopped enrolling patients. First posted on August 19th 2014, the study underwent its last modification on December 2nd 2022. If you are seeking alternative trials there are 2052 studies currently recruiting nsclc patients and 55 studies for Alectinib actively enrolling participants."

Answered by AI

Recent research and studies

The LancetJournal

J-ALEX: Alectinib Versus Crizotinib in ALK -positive Lung Cancer

Gainor, Justin F, and Alice T Shaw. 2017. “J-ALEX: Alectinib Versus Crizotinib in ALK -positive Lung Cancer”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(17)31074-7.

clinicaltrials.govStudy

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

2014. "A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02075840.

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