deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 7-arm NCT05384626

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

A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

Sponsor: Nuvalent Inc.

Conditions Locally Advanced Solid Tumor Metastatic Solid Tumor
Interventions Neladalkib (NVL-655)
Updated 27 times since 2022 Last updated: Oct 28, 2025 Started: Jun 9, 2022 Primary completion: Dec 31, 2027 Completion: Jan 31, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Locally Advanced Solid Tumor and Metastatic Solid Tumor, this trial is actively recruiting participants. The trial is conducted by Nuvalent Inc. and has accumulated 27 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jul 2023 · 2 months · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Jan 2024 · 3 months · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~May 2024 · 2 months · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Aug 2025 · 7 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

27 versions recorded

  1. Dec 2025 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Nov 2025 — Dec 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Sep 2025 — Nov 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Aug 2025 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Jan 2025 — Aug 2025 [monthly]

    Recruiting PHASE1/PHASE2

▶ Show 22 earlier versions

  1. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE1/PHASE2

  2. Sep 2024 — Dec 2024 [monthly]

    Recruiting PHASE1/PHASE2

  3. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

  4. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  6. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE1_PHASE2

  7. Mar 2024 — May 2024 [monthly]

    Recruiting PHASE1_PHASE2

  8. Jan 2024 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

  9. Oct 2023 — Jan 2024 [monthly]

    Recruiting PHASE1_PHASE2

  10. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE1_PHASE2

  11. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  12. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE1_PHASE2

  13. May 2023 — Jul 2023 [monthly]

    Recruiting PHASE1_PHASE2

  14. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE1_PHASE2

  15. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  16. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE1_PHASE2

  17. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE1_PHASE2

  18. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE1_PHASE2

  19. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE1_PHASE2

  20. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1_PHASE2

  21. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  22. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Nuvalent Inc.
Data source: Nuvalent Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

A Coruña, Spain , Amsterdam, Netherlands , Ancona, Italy , Antwerp, Belgium , Atlanta, United States , Aurora, United States , Baltimore, United States , Barcelona, Spain , Bari, Italy , Bellinzona, Switzerland and 55 more locations