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Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Trial for new drug NVL-655 in ALK-positive lung cancer patients.

Recruiting
18 years and older
All
Phase 3

This study is looking at a new medicine called neladalkib, which is being compared to another medicine, alectinib, for patients who have a special kind of lung cancer called ALK-positive NSCLC (Non-Small Cell Lung Cancer). ALK-positive means that the cancer cells have a specific change in a protein called Anaplastic Lymphoma Kinase. The study wants to see if neladalkib helps patients live longer without their cancer getting worse, which is called progression-free survival (PFS).

  • Participation: Around 450 patients will join, and they will be randomly given either neladalkib or alectinib.
  • Eligibility: Only those without previous treatments for this lung cancer can join, and they must have a specific ALK change in their cancer.
  • Exclusions: Patients must not have certain other health conditions, allergies, or recent major surgeries.

The study will help doctors understand if neladalkib is a better choice for treating this type of lung cancer compared to alectinib.

Study details
    Non-small Cell Lung Cancer
    Anaplastic Lymphoma Kinase-positive

NCT06765109

Nuvalent Inc.

7 March 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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