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ALK Inhibitor

Alectinib vs Chemotherapy for Non-Small Cell Lung Cancer

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

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

Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1

Must not have

History of organ transplant

Prior adjuvant radiotherapy for NSCLC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization until death due to any cause up to approximately 8 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is investigating whether the drug alectinib is more effective than platinum-based chemotherapy in treating cancer, and is looking at the safety of both treatments. Participants will receive alectinib or platinum-based chemotherapy and then be followed up to see how their disease progresses.

Who is the study for?

This trial is for adults with ALK-positive Non-Small Cell Lung Cancer who've had surgery to remove the tumor and are eligible for chemotherapy. They must have good blood and kidney function, agree to use effective contraception, and be able to follow study procedures. Excluded are those with significant health issues that could affect the study, prior cancer treatments or organ transplants, pregnant or breastfeeding women, certain GI disorders affecting drug absorption, HIV/AIDS patients, and those unlikely to comply with protocol.

What is being tested?

The trial compares alectinib—a targeted cancer drug taken orally twice daily for two years—with standard platinum-based chemotherapy given in four cycles. The goal is to see which treatment is more effective after lung cancer surgery in preventing disease recurrence. Participants will be randomly assigned to one of these treatments and followed up until disease recurrence or death.

What are the potential side effects?

Alectinib may cause liver problems, muscle pain, constipation, swelling in parts of the body (edema), fatigue, low red blood cell count (anemia), changes in heart rhythm (bradycardia), among others. Platinum-based chemotherapies can lead to nausea/vomiting, hair loss (alopecia), kidney damage (nephrotoxicity), nerve damage (neuropathy) and bone marrow suppression leading to lower blood cells.

Eligibility Criteria

Inclusion Criteria

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

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I am eligible for platinum-based chemotherapy as per guidelines.

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I am fully active or can carry out light work.

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My cancer is ALK-positive based on an approved test.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant.

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I have had radiation therapy for lung cancer before it spread.

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I have a digestive condition that affects how my body absorbs pills.

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My liver is not functioning properly due to high enzyme levels or other serious conditions.

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I am HIV positive or have an AIDS-related illness.

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I experience symptoms due to a very slow heartbeat.

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I have previously been treated with cancer drugs and ALK inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization until death due to any cause up to approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization until death due to any cause up to approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until death due to any cause up to approximately 8 years for reporting.