Clinical trial NCT06834074: Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC
Official title: Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Non Small Cell Lung Cancer
ALK-positive Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Nuvalent Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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 lorlatinib or a second-generation ALK tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement or activating ALK mutation.
3. Previously received lorlatinib or received at least one second-generation ALK TKI and is either not eligible for or does not have access to lorlatinib, 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Lyon
country: France
facility: Centre Leon Berard
state: Auvergne-Rhône-Alpes
city: Toulouse
country: France
facility: GCS IUCT Oncopole
state: Occitanie
city: Nantes
country: France
facility: CHU de Nantes
state: Pays De La Loire
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Île-de-France
city: Amsterdam
country: Netherlands
facility: Stichting Het Nederlands Kanker Instituut
state: North Holland
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Lucerne
country: Switzerland
facility: Kantonsspital Luzern
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
state: UK
Study officials:
References: