Access Program for Neladalkib (NVL-655) for Patients with Advanced ALK+ Lung Cancer
Sponsor: Nuvalent Inc.
ClinicalTrials ID:NCT06834074
This program allows patients with advanced ALK-positive lung cancer, who cannot join a clinical trial and have no other treatment options, to access the investigational drug neladalkib.
Patient Parameters
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Program Overview
The Expanded Access Program is designed to provide the investigational drug neladalkib to patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have already tried other treatments like lorlatinib or similar drugs and have no other satisfactory treatment options. This program is for patients who cannot join a clinical trial for neladalkib.
Description
This program aims to offer the investigational drug neladalkib to patients with advanced ALK-positive lung cancer who have already been treated with lorlatinib or another similar drug and have no other good treatment options. It is specifically for those who cannot join a clinical trial for neladalkib. The drug is an ALK inhibitor, which means it targets a specific mutation in the cancer cells to help control the disease.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) with a specific ALK mutation.
- Have previously been treated with lorlatinib or at least one other similar drug and cannot use lorlatinib again or have no other good treatment options, as determined by the doctor.
- Cannot join a clinical trial for neladalkib.
- Have good organ function and enough healthy blood cells.
Exclusion Criteria
- Have previously received neladalkib.
- Have had recent surgery, chemotherapy, radiation, or other cancer treatments, or participated in other studies within a specific timeframe.
- Are currently receiving other cancer treatments.
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