marked.bio

Company

Nuvalent

4 active trials that select patients by a biomarker on marked.bio, across 3 biomarkers; 1 in phase 3.

Counts only trials this company leads as sponsor, not partnered or academic trials of its drugs.

Biomarkers

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

neladalkib 2alectinib 1zidesamtinib 1

Trials

4 of 4 trials shown

  1. Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

    Recruiting Phase 3 Nuvalent Started 2025Primary completion 2029-12 NCT06765109

    neladalkibalectinib FDA EU

    Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood

    ALK fusionNon-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive

  2. A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

    Recruiting Phase 1/2 Nuvalent Started 2022Primary completion 2027-12 NCT05384626

    neladalkibmidazolamRepaglinideitraconazole

    …y or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.

    ALK fusionLocally Advanced Solid Tumor, Metastatic Solid Tumor

  3. A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

    Recruiting Phase 1/2 Nuvalent Started 2022Primary completion 2027-12 NCT05118789

    zidesamtinib FDA

    …lly or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.

    ROS1 fusionLocally Advanced Solid Tumor, Metastatic Solid Tumor

  4. A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

    Recruiting Phase 1 Nuvalent Started 2024Primary completion 2027-01 NCT06521554

    NVL-330

    Phase 1b: Documented oncogenic HER2 mutation.

    HER2 (ERBB2) activating mutationLocally Advanced Solid Tumor, Metastatic Solid Tumor