Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
ALK-positive Solid Tumors
Brief 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.
Detailed description
The purpose of this Expanded Access Program is to provide investigational ALK inhibitor, neladalkib (NVL-655), for eligible patients with ALK-positive locally advanced or metastatic NSCLC (ALK+ NSCLC) who have previously received an ALK tyrosine kinase inhibitor (TKI) or eligible patients with other ALK-positive solid tumors, and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.
Interventions
DRUGNVL-655
Drug: NVL-655
Sponsors
Nuvalent Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Countries
Australia, Canada, France, Italy, Netherlands, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
CONTACTContact for Program Information
Outcome results
None listed