Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorNuvalent Inc.
About this trial
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
Qualifiers
Age ≥18 years.
Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumors with a documented ALK rearrangement or activating ALK mutation.
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.
Enrollment in a clinical trial of neladalkib is not possible.
Disqualifiers
Prior receipt of neladalkib.
Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
Ongoing anti-cancer therapy.
Trial design
Treatments tested in this trial
- NVL-655
Treatment groups
No treatment groups listed
Locations
46Australia
Royal North Shore Hospital2065, St LeonardsNew South Wales, Australia
Peter MacCallum Cancer Centre3000, MelbourneVictoria, Australia
Canada
Cross Cancer InstituteAB T6G 1Z2, EdmontonAlberta, Canada
BC Cancer - VancouverV5Z 4E6, VancouverBritish Columbia, Canada
Sponsors and collaborators
Nuvalent Inc.
Lead sponsor
Source ClinicalTrials.gov