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

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial compares two medications, alectinib and crizotinib, for treating a specific type of advanced lung cancer. The patients have not received any prior treatment for their cancer. Both drugs work by blocking a protein that helps the cancer cells grow. Alectinib has shown superior effectiveness and fewer side effects compared to crizotinib in treating this type of lung cancer.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

I am not pregnant.

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

Exclusion Criteria

I have a stomach or liver condition.

My heart's electrical activity (QTc) is over 470 milliseconds, or I have slow heartbeat symptoms.

I am allergic to ingredients in alectinib or crizotinib.

I have experienced severe side effects from previous cancer treatments, except for hair loss.

I haven't taken strong drugs that affect liver enzymes in the last 14 days.

I have had cancer within the last 3 years.

I have had an organ transplant.

Treatment Details

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.

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.

Alectinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Alecensa for: