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RecruitingLast updated: 2 February 2024

AROS-1: This phase I/II study is seeking to determine the best dose level, safety and effectiveness of a new cancer drug (NVL-250) in people with locally advanced solid cancersA Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)

Clinical summary

Summary

This study has two parts. Phase 1 will determine the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of NVL-520 in people with advanced ROS1-positive solid cancers. In this phase, NVL-520 will be given orally, daily. Phase 2 will determine the objective response rate (ORR) and effectiveness of NVL-520 in people with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid cancers. Phase 2 will have 5 cohorts. Cohort 2a will recruit people with ROS1-positive NSCLC who are naive to Tyrosine Kinase Inhibitor (TKI) therapy. Cohort 2b will recruit people with ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior platinum-based chemotherapy with or without immunotherapy. Cohort 2c will recruit people with ROS1-positive NSCLC who have been treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy. Cohort 2d will recruit people with ROS1-positive NSCLC who have been treated with ≥2 prior ROS1 TKIs and up to 1 prior platinum-based chemotherapy with or without immunotherapy. Cohort 2e will recruit people with ROS-1 positive solid cancers who have progressed on any prior therapy.

Conditions

This trial is treating patients with ROS1-positive non-small cell lung cancer and other advanced ROS1-positive solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People12+

Phase

I/II

Trial Acronym

AROS-1

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Nuvalent Inc.

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)

Eligibility

Inclusion

  1. Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing>40 kg).

  2. Disease Criteria:

    1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.
    2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.
    3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.
  3. Prior anticancer treatment (except cohort 2a).
  4. 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.
  5. Adequate baseline organ function and bone marrow reserve.

Exclusion

  1. Patient's cancer has a known oncogenic driver alteration other than ROS1.
  2. Known allergy/hypersensitivity to excipients of NVL-520.
  3. Major surgery within 4 weeks of first dose of study drug.
  4. Ongoing anticancer therapy.
  5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

Inclusion

  • You are able to swallow medication by mouth.
  • You are currently receiving treatment for your cancer.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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