Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06834074




Registration number
NCT06834074
Ethics application status
Date submitted
11/02/2025
Date registered
19/02/2025
Date last updated
8/05/2025

Titles & IDs
Public title
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC
Scientific title
Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC
Secondary ID [1] 0 0
NVL-655-EAP
Universal Trial Number (UTN)
Trial acronym
NVL-655-EAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
ALK-positive Non-small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - NVL-655

Treatment: Drugs: NVL-655
Drug: NVL-655
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
1. Age =18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement or activating ALK mutation.
3. Previously received lorlatinib or received at least one second-generation ALK TKI and is either not eligible for or does not have access to lorlatinib, 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
AVAILABLE
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
France
State/province [5] 0 0
Auvergne-Rhône-Alpes
Country [6] 0 0
France
State/province [6] 0 0
Occitanie
Country [7] 0 0
France
State/province [7] 0 0
Pays De La Loire
Country [8] 0 0
France
State/province [8] 0 0
Île-de-France
Country [9] 0 0
Netherlands
State/province [9] 0 0
North Holland
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
Switzerland
State/province [11] 0 0
Lucerne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nuvalent Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Contact for Program Information
Address 0 0
Country 0 0
Phone 0 0
877 768 4303
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06834074