deltatrials
Recruiting PHASE3 INTERVENTIONAL 2-arm NCT06765109

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

A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

Sponsor: Nuvalent Inc.

Updated 9 times since 2025 Last updated: Feb 12, 2026 Started: Jul 17, 2025 Primary completion: Dec 31, 2029 Completion: Dec 31, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Anaplastic Lymphoma Kinase-positive and Non-small Cell Lung Cancer, this trial is actively recruiting participants. The trial is conducted by Nuvalent Inc. and has accumulated 9 data snapshots since 2025. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshotRecruiting~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshotRecruiting

Change History

9 versions recorded
  1. Feb 2026 — Present [monthly]

    Recruiting PHASE3

  2. Jan 2026 — Feb 2026 [monthly]

    Recruiting PHASE3

  3. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE3

  4. Nov 2025 — Dec 2025 [monthly]

    Recruiting PHASE3

  5. Oct 2025 — Nov 2025 [monthly]

    Recruiting PHASE3

Show 4 earlier versions
  1. Sep 2025 — Oct 2025 [monthly]

    Recruiting PHASE3

  2. Apr 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

  3. Mar 2025 — Apr 2025 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  4. Feb 2025 — Mar 2025 [monthly]

    Not Yet Recruiting PHASE3

    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 .