AVAILABLENot Applicable

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

United States

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Adequate organ function and bone marrow reserve.

Exclusion criteria

✕. 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 details

NCT IDNCT06834074

SponsorNuvalent Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Contact for this trial

Contact for Program Information

877 768 4303 MedicineAccess@clinigengroup.com

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials