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Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors

NCT06834074

AvailableN/A

Sponsor: Nuvalent Inc.

Conditions: Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)

Interventions: NVL-655

Countries: United States, Australia, Canada, France, Italy, Netherlands, Singapore, South Korea

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 overview

Sex: ALL

Age: 18 Years to —

Study type: EXPANDED_ACCESS

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.
Locations (47)
  • Orange, California, United States
  • Aurora, Colorado, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Columbus, Ohio, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • St Leonards, New South Wales, Australia
  • Melbourne, Victoria, Australia
  • Edmonton, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Lyon, Auvergne-Rhône-Alpes, France
  • Toulouse, Occitanie, France
  • Nantes, Pays de la Loire Region, France
  • Villejuif, Île-de-France Region, France
  • Ancona, Italy
  • Milan, Italy
  • Milan, Italy
  • Padova, Italy
  • Ravenna, Italy
  • Rome, Italy
  • Amsterdam, North Holland, Netherlands
  • + 17 more on CT.gov