Clinical trial NCT06797362: Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
Official title: Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Non Small Cell Lung Cancer
ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
Lead sponsor: Nuvalent Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumor with documented ROS1 rearrangement.
3. Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
4. Enrollment in a clinical trial of zidesamtinib is not possible.
5. Adequate organ function and bone marrow reserve.

Exclusion Criteria:

1. Prior receipt of zidesamtinib.
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.
4. Eligible for ongoing clinical trial with zidesamtinib

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Lyon
country: France
facility: Centre Leon Berard
state: Auvergne-Rhône-Alpes
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Île-de-France
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute: NKI
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
state: Surrey
Study officials:
References: