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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2026
  • participants needed
    247
  • sponsor
    Nuvalent Inc.
Updated on 24 October 2022

Summary

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors.

Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors.

Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.

Description

In Phase 2, study patients will be enrolled into 5 distinct expansion cohorts:

  • Cohort 2a: ROS1-positive NSCLC naïve to Tyrosine Kinase Inhibitor (TKI) therapy.
  • Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior platinum-based chemotherapy with or without immunotherapy.
  • Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy.
  • Cohort 2d: ROS1-positive NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior platinum-based chemotherapy with or without immunotherapy.
  • Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.

Details
Condition Locally Advanced Solid Tumor, Metastatic Solid Tumor
Treatment NVL-520
Clinical Study IdentifierNCT05118789
SponsorNuvalent Inc.
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

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
Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement
Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement
Prior anticancer treatment (except cohort 2a)
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

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
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