deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT04111705

Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer (ORAKLE)

A Phase II Non-randomized, Single Group Assignment, Open-label, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

Sponsor: Intergroupe Francophone de Cancerologie Thoracique

Interventions Lorlatinib
Updated 14 times since 2019 Last updated: Mar 26, 2025 Started: Aug 5, 2020 Primary completion: Aug 11, 2022 Completion: Dec 15, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Non Small Cell Lung Cancer Metastatic, this trial is completed. The trial is conducted by Intergroupe Francophone de Cancerologie Thoracique and has accumulated 14 data snapshots since 2020. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Nov 2019 – ~Mar 2020 · 4 months · monthly snapshot~Mar 2020 – ~May 2020 · 2 months · monthly snapshot~May 2020 – ~Aug 2020 · 3 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~May 2022 · 16 months · monthly snapshot~May 2022 – ~Oct 2023 · 17 months · monthly snapshot~Oct 2023 – ~Apr 2024 · 6 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~May 2025 · 6 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

14 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. May 2025 — Sep 2025 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  3. Nov 2024 — May 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

Show 9 earlier versions
  1. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Oct 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  3. May 2022 — Oct 2023 [monthly]

    Recruiting PHASE2

  4. Jan 2021 — May 2022 [monthly]

    Recruiting PHASE2

  5. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  6. Aug 2020 — Oct 2020 [monthly]

    Recruiting PHASE2

  7. May 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  8. Mar 2020 — May 2020 [monthly]

    Not Yet Recruiting PHASE2

  9. Nov 2019 — Mar 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Intergroupe Francophone de Cancerologie Thoracique
Data source: Intergroupe Francophone de Cancerologie Thoracique

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