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Available
NCT06834074
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
Conditions: Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)
Sex: All
Ages: 18 Years – N/A
Sponsor: Nuvalent Inc.
Location: University Of California Irvine Medical Center Orange California
Summary
The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumors with a documented ALK rearrangement or activating ALK mutation.
3. Previously received at least one ALK TKI (for patients with NSCLC) or any prior therapy (for patients with other solid tumors), with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
4. Enrollment in a clinical trial of neladalkib is not possible.
5. Adequate organ function and bone marrow reserve.
Exclusion Criteria:
1. Prior receipt of neladalkib.
2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
3. Ongoing anti-cancer therapy.
Source: ClinicalTrials.gov (NCT06834074). StuddyBuddy aggregates publicly available trial information.
