Non Small Cell Lung CancerNCT06797362
Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
A study testing NVL-520 in people with Non Small Cell Lung Cancer and ROS1-positive Non-Small Cell Lung Cancer (NSCLC), run by Nuvalent Inc. at 30 sites in 10 countries.
Trial summary
The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- NVL-520
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 30 sitesin 10 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 tumor with documented ROS1 rearrangement.
- Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
- Enrollment in a clinical trial of zidesamtinib is not possible.
- Adequate organ function and bone marrow reserve.
Who cannot join
- Prior receipt of zidesamtinib.
- Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
- Ongoing anti-cancer therapy.
- Eligible for ongoing clinical trial with zidesamtinib
Trial locations and contacts
30 sites in 10 countries.
30 sites in 10 countries
Italy6 sites
- Available
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124
- Available
L'Istituto Europeo di Oncologia S.r.l.
Milan, 20141
- Available
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
- Available
IRCCS Istituto Oncologico Veneto
Padova, 35128
- Available
AUSL della Romagna - Ravenna
Ravenna, 48121
- Available
Istituto Nazionale Tumori "Regina Elena
Roma, 00144
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
Uomi Cancer Center-Clinica Tres Torres
Barcelona, 08017
- Available
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Available
Gregorio Marañón General University Hospital
Madrid, 28007
- Available
Hospital Univ Doce de Octubre
Madrid, 28041
Netherlands3 sites
- Available
Antoni van Leeuwenhoek Hospital
Amsterdam, 1006 BE
- Available
Netherlands Cancer Institute: NKI
Amsterdam, 1066 CX
- Available
University Medical Center Groningen
Groningen, 9713 GZ
Taiwan3 sites
- Available
Chung Shan Medical University
Taichung, 402306
- Available
National Cheng Kung University Hospital
Tainan, 70403
- Available
National Taiwan University Hospital
Taipei, 100229
United Kingdom3 sites
- Available
The Royal Marsden Hospital
London, SM2 5PT
- Available
The Christie Hospital
Manchester, M20 4BX
- Available
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Australia2 sites
- Available
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
- Available
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Canada2 sites
- Available
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
- Available
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Singapore2 sites
- Available
National University Hospital Singapore
Singapore, 119074
- Available
National Cancer Centre Singapore
Singapore, 168583
About this study
Official title: Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.
Read the detailed description
The purpose of this Expanded Access Program is to provide access to zidesamtinib (NVL-520) an investigational therapy for eligible patients with ROS1 fusion-positive advanced non- small cell lung cancer (ROS1+ NSCLC) who have previously received ≥ 1 prior ROS1 tyrosine kinase inhibitor (TKI) or eligible patients with other ROS1-positive solid tumors who have previously received any prior commercially-available or investigational therapy, and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.
- Being tested
- NVL-520
- 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-520Drug
Also called Zidesamtinib
Oral tablet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 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
- NCT06797362
- Sponsor's protocol ID
- NVL-520-EAP
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
- ClinicalTrials.gov ID
- NCT06797362
- Acronym / sponsor ID
- NVL-520-EAP
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Nuvalent Inc.Industry (pharma, biotech, devices)
- First posted
- 28 Jan 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 these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.
Detailed description
The purpose of this Expanded Access Program is to provide access to zidesamtinib (NVL-520) an investigational therapy for eligible patients with ROS1 fusion-positive advanced non- small cell lung cancer (ROS1+ NSCLC) who have previously received ≥ 1 prior ROS1 tyrosine kinase inhibitor (TKI) or eligible patients with other ROS1-positive solid tumors who have previously received any prior commercially-available or investigational therapy, and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.
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 tumor with documented ROS1 rearrangement.
- Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
- Enrollment in a clinical trial of zidesamtinib is not possible.
- Adequate organ function and bone marrow reserve.
Key exclusion criteria (4 listed)
- Prior receipt of zidesamtinib.
- Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
- Ongoing anti-cancer therapy.
- Eligible for ongoing clinical trial with zidesamtinib
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-520Also: ZidesamtinibOral tablet | 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 25 Aug 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.
30 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NVL-520 in people with Non Small Cell Lung Cancer and ROS1-positive Non-Small Cell Lung Cancer (NSCLC), run by Nuvalent Inc. at 30 sites in 10 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 4 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy, France, Spain, Netherlands, Taiwan and 5 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 25 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.