臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 12, 2024
Last modified on	Mar. 12, 2024
Trial ID	jRCT2031230693

Scientific Title	A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)
Public Title	A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Contact for Scientific Queries	Name	Upadhyay Vivek
	Affiliation	Vice President, Clinical Development
	Address	One Broadway, 14th Floor Cambridge, Massachusetts 02142 USA
	Telephone	1-857-357-7000
	E-mail	clinicaltrials@nuvalent.com
Contact for Public Queries	Name	Kitahashi Kazuyuki
	Affiliation	A2 Healthcare Corporation
	Address	Sumitomo Fudosan Korakuen Bldg, 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
	Telephone	+81-3-3830-1756
	E-mail	NVL-520_trialinfomation@a2healthcare.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 01, 2024
Actual date of first enrollment
Target sample size		15
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Age >=18 years (Cohort 2e only: Age >=12 years and weighing>40 kg). Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease according to RECIST 1.1. Adequate baseline organ function and bone marrow reserve. Prior therapy requirements Cohort 2a: ROS1-positive NSCLC naive to Tyrosine Kinase Inhibitor (TKI) therapy and up to 1 prior chemotherapy and/or immunotherapy. Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy. Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy. Cohot 2d: ROS1-positive NSCLC treated with >=2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy. Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.
	Exclusion Criteria	Patient's cancer has a known oncogenic driver alteration other than ROS1. Known allergy/hypersensitivity to excipients of NVL-520. Major surgery within 4 weeks of first dose of study drug. Ongoing anticancer therapy. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
	Age Minimum	12age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Advanced NSCLC and Other Solid Tumors
Intervention(s)		IMP: NVL-520 NVL-520 is a tablet taken by mouth. Patients will receive study drug continuously from first dose until disease progression, unacceptable toxicity, withdrawal by patient, or Investigator's decision. Patients who are deriving clinical benefit in the opinion of the Investigator may continue to receive NVL-520 following disease progression at the discretion of the Investigator in consultation with the Sponsor.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Maximum tolerated dose (Phase 1): Highest dose with dose-limiting toxicity (DLT) rate =< 25% RP2D: To determine the RP2D Objective Response Rate (ORR) (Phase 2): To determine ORR as assessed by BICR
Secondary Outcome(s)

Primary Sponsor	Nuvalent, Inc. (ICCC: A2 Healthcare Corporation)

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cancer Center Hospital Institutional Review Board
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-3542-2511
E-Mail	chiken_CT@ml.res.ncc.go.jp
Approval Status
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	USA/UK/Italy/Australia/Belgium/Canada/France/Netherlands/Spain/Germany/Taiwan/Singapore/South Korea