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AvailableNot applicableNCT06834074
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNVL-655

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 21, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Available

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Expanded Access

Where is it offered?50 U.S. locations

Locations may change over time.

Who runs it?Nuvalent Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Expanded Access
Phase
Not applicable
Sponsor
Nuvalent Inc.
Interventions being studied
Drug: NVL-655
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
ALK→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

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

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 21, 2026. Always confirm current availability with the study team.

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