---
title: Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
nct_id: NCT06834074
overall_status: AVAILABLE
sponsor: Nuvalent Inc.
study_type: EXPANDED_ACCESS
primary_condition: Non Small Cell Lung Cancer
countries: United States, Australia, Canada, France, Italy, Netherlands, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06834074.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06834074"
ct_last_update_post_date: 2026-05-07
last_seen_at: "2026-05-12T06:52:42.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors

**Official Title:** Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors

**NCT ID:** [NCT06834074](https://clinicaltrials.gov/study/NCT06834074)

## Key Facts

- **Status:** AVAILABLE
- **Study Type:** EXPANDED_ACCESS
- **Lead Sponsor:** Nuvalent Inc.
- **Conditions:** Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)
- **CT.gov Last Update:** 2026-05-07

## 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 an ALK tyrosine kinase inhibitor (TKI) or eligible patients with other ALK-positive solid tumors, and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

```
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.
```

## Interventions

- **NVL-655** (DRUG) — Drug: NVL-655

## Locations (44)

- University Of California Irvine Medical Center, Orange, California, United States — _AVAILABLE_
- University of Colorado Anschutz School of Medicine, Aurora, Colorado, United States — _AVAILABLE_
- University of Chicago Medical Center, Chicago, Illinois, United States — _AVAILABLE_
- Massachusetts General Hospital, Boston, Massachusetts, United States — _AVAILABLE_
- Dana-Farber Cancer Institute, Boston, Massachusetts, United States — _AVAILABLE_
- Henry Ford Cancer Institute, Detroit, Michigan, United States — _AVAILABLE_
- Washington University in St. Louis, St Louis, Missouri, United States — _AVAILABLE_
- NYU Langone Health, New York, New York, United States — _AVAILABLE_
- Memorial Sloan Kettering Cancer Center, New York, New York, United States — _AVAILABLE_
- Duke University, Durham, North Carolina, United States — _AVAILABLE_
- The Ohio State University, Columbus, Ohio, United States — _AVAILABLE_
- The University of Texas MD Anderson Cancer Center, Houston, Texas, United States — _AVAILABLE_
- University of Washington / Fred Hutchinson Cancer Center, Seattle, Washington, United States — _AVAILABLE_
- Royal North Shore Hospital, St Leonards, New South Wales, Australia — _AVAILABLE_
- Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia — _AVAILABLE_
- Cross Cancer Institute, Edmonton, Alberta, Canada — _AVAILABLE_
- BC Cancer - Vancouver, Vancouver, British Columbia, Canada — _AVAILABLE_
- Princess Margaret Hospital, Toronto, Ontario, Canada — _AVAILABLE_
- Centre Leon Berard, Lyon, Auvergne-Rhône-Alpes, France — _AVAILABLE_
- GCS IUCT Oncopole, Toulouse, Occitanie, France — _AVAILABLE_
- CHU de Nantes, Nantes, Pays de la Loire Region, France — _AVAILABLE_
- Institut Gustave Roussy, Villejuif, Île-de-France Region, France — _AVAILABLE_
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy — _AVAILABLE_
- L'Istituto Europeo di Oncologia S.r.l., Milan, Italy — _AVAILABLE_
- IRCCS Istituto Oncologico Veneto, Padova, Italy — _AVAILABLE_
- AUSL della Romagna - Ravenna, Ravenna, Italy — _AVAILABLE_
- IRCCS Istituto Nazionale Tumori Regina Elena, Rome, Italy — _AVAILABLE_
- Stichting Het Nederlands Kanker Instituut, Amsterdam, North Holland, Netherlands — _AVAILABLE_
- Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands — _AVAILABLE_
- University Medical Center Groningen, Groningen, Netherlands — _AVAILABLE_
- National University Hospital Singapore, Singapore, Singapore — _AVAILABLE_
- National Cancer Centre Singapore, Singapore, Singapore — _AVAILABLE_
- Seoul National University Hospital, Seoul, Jongno-gu, South Korea — _AVAILABLE_
- Gerencia de Gestión Integrada A Coruna, A Coruña, Spain — _AVAILABLE_
- Uomi Cancer Center-Clinica Tres Torres, Barcelona, Spain — _AVAILABLE_
- Hospital Universitario Vall d'Hebron, Barcelona, Spain — _AVAILABLE_
- Hospital Universitario 12 de Octubre, Madrid, Spain — _AVAILABLE_
- Kantonsspital Luzern, Lucerne, Switzerland — _AVAILABLE_
- Ospedale Italiano di Lugano, Viganello, Switzerland — _AVAILABLE_
- National Cheng-Kung University Hospital, Tainan, Taiwan — _AVAILABLE_
- National Taiwan University Hospital, Taipei, Taiwan — _AVAILABLE_
- The Royal Marsden Hospital, Sutton, Surrey, United Kingdom — _AVAILABLE_
- The Royal Marsden Hospital, London, UK, United Kingdom — _AVAILABLE_
- The Christie Hospital, Manchester, United Kingdom — _AVAILABLE_

## Recent Field Changes (last 30 days)

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- `status.overallStatus` — added _(2026-05-12)_
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- `locations.duke university|durham|north carolina|united states` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of california irvine medical center|orange|california|united states` — added _(2026-05-12)_
- `locations.university of colorado anschutz school of medicine|aurora|colorado|united states` — added _(2026-05-12)_
- `locations.university of chicago medical center|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.massachusetts general hospital|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.dana-farber cancer institute|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.henry ford cancer institute|detroit|michigan|united states` — added _(2026-05-12)_
- `locations.washington university in st. louis|st louis|missouri|united states` — added _(2026-05-12)_
- `locations.nyu langone health|new york|new york|united states` — added _(2026-05-12)_
- `locations.the ohio state university|columbus|ohio|united states` — added _(2026-05-12)_
- `locations.the university of texas md anderson cancer center|houston|texas|united states` — added _(2026-05-12)_
- `locations.university of washington / fred hutchinson cancer center|seattle|washington|united states` — added _(2026-05-12)_
- `locations.royal north shore hospital|st leonards|new south wales|australia` — added _(2026-05-12)_
- `locations.peter maccallum cancer centre|melbourne|victoria|australia` — added _(2026-05-12)_
- `locations.cross cancer institute|edmonton|alberta|canada` — added _(2026-05-12)_
- `locations.bc cancer - vancouver|vancouver|british columbia|canada` — added _(2026-05-12)_
- `locations.princess margaret hospital|toronto|ontario|canada` — added _(2026-05-12)_
- `locations.centre leon berard|lyon|auvergne-rhône-alpes|france` — added _(2026-05-12)_
- `locations.gcs iuct oncopole|toulouse|occitanie|france` — added _(2026-05-12)_
- `locations.chu de nantes|nantes|pays de la loire region|france` — added _(2026-05-12)_
- `locations.institut gustave roussy|villejuif|île-de-france region|france` — added _(2026-05-12)_
- `locations.fondazione irccs istituto nazionale dei tumori|milan||italy` — added _(2026-05-12)_
- `locations.l'istituto europeo di oncologia s.r.l.|milan||italy` — added _(2026-05-12)_
- `locations.irccs istituto oncologico veneto|padova||italy` — added _(2026-05-12)_
- `locations.ausl della romagna - ravenna|ravenna||italy` — added _(2026-05-12)_
- `locations.irccs istituto nazionale tumori regina elena|rome||italy` — added _(2026-05-12)_
- `locations.stichting het nederlands kanker instituut|amsterdam|north holland|netherlands` — added _(2026-05-12)_
- `locations.antoni van leeuwenhoek hospital|amsterdam||netherlands` — added _(2026-05-12)_
- `locations.university medical center groningen|groningen||netherlands` — added _(2026-05-12)_
- `locations.national university hospital singapore|singapore||singapore` — added _(2026-05-12)_
- `locations.national cancer centre singapore|singapore||singapore` — added _(2026-05-12)_
- `locations.seoul national university hospital|seoul|jongno-gu|south korea` — added _(2026-05-12)_
- `locations.gerencia de gestión integrada a coruna|a coruña||spain` — added _(2026-05-12)_
- `locations.uomi cancer center-clinica tres torres|barcelona||spain` — added _(2026-05-12)_
- `locations.hospital universitario vall d'hebron|barcelona||spain` — added _(2026-05-12)_
- `locations.hospital universitario 12 de octubre|madrid||spain` — added _(2026-05-12)_
- `locations.kantonsspital luzern|lucerne||switzerland` — added _(2026-05-12)_
- `locations.ospedale italiano di lugano|viganello||switzerland` — added _(2026-05-12)_
- `locations.national cheng-kung university hospital|tainan||taiwan` — added _(2026-05-12)_
- `locations.national taiwan university hospital|taipei||taiwan` — added _(2026-05-12)_
- `locations.the royal marsden hospital|sutton|surrey|united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06834074.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06834074*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*