Non Small Cell Lung CancerNVL-655-EAPNCT06834074
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
A study testing NVL-655 in people with Non Small Cell Lung Cancer and ALK-positive Non-small Cell Lung Cancer (NSCLC), run by Nuvalent Inc. at 50 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- NVL-655
- How many people
- Not given
- Where
- 50 sitesin 12 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
50 sites in 12 countries.
50 sites in 12 countries
United States13 sites
- Available
University of Colorado Anschutz School of Medicine
Aurora, Colorado, 80045
- Available
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Available
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Available
University of Chicago Medical Center
Chicago, Illinois, 60637
- Available
The Ohio State University
Columbus, Ohio, 43210
- Available
Henry Ford Cancer Institute
Detroit, Michigan, 48202
- Available
Duke University
Durham, North Carolina, 27708
- Available
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Available
NYU Langone Health
New York, New York, 10016
- Available
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Available
University Of California Irvine Medical Center
Orange, California, 92868
- Available
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Available
Washington University in St. Louis
St Louis, Missouri, 63110
Italy7 sites
- Available
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
- Available
Istituto Tumori Giovanni Paolo II
Bari, 70124
- Available
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
- Available
L'Istituto Europeo di Oncologia S.r.l.
Milan, 20141
- Available
IRCCS Istituto Oncologico Veneto
Padova, 35128
- Available
AUSL della Romagna - Ravenna
Ravenna, 48121
- Available
IRCCS Istituto Nazionale Tumori Regina Elena
Rome, 53
Canada4 sites
- Available
Cross Cancer Institute
Edmonton, Alberta, AB T6G 1Z2
- Available
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
- Available
Princess Margaret Hospital
Toronto, Ontario, ON M5G 2M9
- Available
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
France4 sites
- Available
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69008
- Available
CHU de Nantes
Nantes, Pays de la Loire Region, 44800
- Available
GCS IUCT Oncopole
Toulouse, Occitanie, 31059
- Available
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94800
Spain4 sites
- Available
Gerencia de Gestión Integrada A Coruna
A Coruña, 15006
- Available
Uomi Cancer Center-Clinica Tres Torres
Barcelona, 08017
- Available
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Available
Hospital Universitario 12 de Octubre
Madrid, 28041
Australia3 sites
- Available
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Available
Royal North Shore Hospital
St Leonards, New South Wales, 2065
- Available
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Netherlands3 sites
- Available
Stichting Het Nederlands Kanker Instituut
Amsterdam, North Holland, 1066 CX
- Available
Antoni van Leeuwenhoek Hospital
Amsterdam, 1006 BE
- Available
University Medical Center Groningen
Groningen, 9713 GZ
Taiwan3 sites
- Available
Chung Shan Medical University
Taichung, 402306
- Available
National Cheng-Kung University Hospital
Tainan, 704
- Available
National Taiwan University Hospital
Taipei, 100
United Kingdom3 sites
- Available
The Royal Marsden Hospital
London, UK, SW3 6JJ
- Available
The Christie Hospital
Manchester, M20 4BX
- Available
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Singapore2 sites
- Available
National University Hospital Singapore
Singapore, 119074
- Available
National Cancer Centre Singapore
Singapore, 168583
South Korea2 sites
- Available
Seoul National University Hospital
Seoul, Jongno-gu, 03080
- Available
Severance Hospital Yonsei University Health System
Seoul, 03722
Switzerland2 sites
- Available
Kantonsspital Luzern
Lucerne, 6000
- Available
Ospedale Italiano di Lugano
Viganello, 6962
About this study
Official title: Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
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.
Read the 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.
- Being tested
- NVL-655
- Keywords
- ALK-positive Solid Tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVL-655Drug
Also called Neladalkib
Drug: NVL-655
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Nuvalent Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834074
- Sponsor's protocol ID
- NVL-655-EAP
- Acronym
- NVL-655-EAP
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
- ClinicalTrials.gov ID
- NCT06834074
- Acronym / sponsor ID
- NVL-655-EAP / NVL-655-EAP
- Keywords
- ALK-positive Solid Tumors
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Nuvalent Inc.Industry (pharma, biotech, devices)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVL-655Also: NeladalkibDrug: NVL-655 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
50 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NVL-655 in people with Non Small Cell Lung Cancer and ALK-positive Non-small Cell Lung Cancer (NSCLC), run by Nuvalent Inc. at 50 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Italy, Canada, France, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Contact for Program Information (877 768 4303, MedicineAccess@clinigengroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.