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Study identifier: NCT06834074 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: AvailableNVL-655-EAP

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

Condition: Non Small Cell Lung Cancer · ALK-positive Non-small Cell Lung Cancer (NSCLC)  ·  Sponsor: Nuvalent Inc.

PhaseN/A
Planned participants
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where47 locations · 12 countries

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact for Program Information  ·  877 768 4303  ·  MedicineAccess@clinigengroup.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (47)

University Of California Irvine Medical CenterOrange, California, United StatesAvailable
University of Colorado Anschutz School of MedicineAurora, Colorado, United StatesAvailable
University of Chicago Medical CenterChicago, Illinois, United StatesAvailable
Massachusetts General HospitalBoston, Massachusetts, United StatesAvailable
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesAvailable
Henry Ford Cancer InstituteDetroit, Michigan, United StatesAvailable
Washington University in St. LouisSt Louis, Missouri, United StatesAvailable
NYU Langone HealthNew York, New York, United StatesAvailable
Memorial Sloan Kettering Cancer CenterNew York, New York, United StatesAvailable
Duke UniversityDurham, North Carolina, United StatesAvailable
The Ohio State UniversityColumbus, Ohio, United StatesAvailable
The University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesAvailable

+ 35 more locations — full list on the registry record.

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