NCT04111705 (ORAKLE) is a Phase 2 clinical trial of Lorlatinib in Non Small Cell Lung Cancer Metastatic, sponsored by Intergroupe Francophone de Cancerologie Thoracique.

Who is sponsoring NCT04111705?

NCT04111705 is sponsored by Intergroupe Francophone de Cancerologie Thoracique.

What drugs are being tested in NCT04111705?

Interventions in NCT04111705: Lorlatinib.

What condition does NCT04111705 study?

NCT04111705 studies Non Small Cell Lung Cancer Metastatic.

Is NCT04111705 still recruiting?

NCT04111705 is currently completed. Last updated 1 April 2025.

Last reviewed 2025-04-01 · How we verify

NCT04111705: ORAKLE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 1 April 2025

What this trial tests

Phase 2 trial testing Lorlatinib in Non Small Cell Lung Cancer Metastatic in 23 participants. Completed in 15 December 2024.

Timeline

5 August 2020

Primary endpoint
11 August 2022

15 December 2024

Quick facts

Lead sponsor	Intergroupe Francophone de Cancerologie Thoracique
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	5 August 2020
Primary completion	11 August 2022
Estimated completion	15 December 2024
Sites	32 locations across France

Drugs / interventions tested

Lorlatinib (lorlatinib) — full drug profile →

Conditions studied

Non Small Cell Lung Cancer Metastatic — all drugs for Non Small Cell Lung Cancer Metastatic →

Sponsor

Intergroupe Francophone de Cancerologie Thoracique — full company profile →

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement. Alectinib, ceritinib and brigatinib are second-generation ITK-ALK. They have been shown to be effective in the first line of treatment in randomized trials. Alectinib has shown superiority to crizotinib as the first line of treatment in three randomized therapeutic trials, positioning this ITK-ALK as the treatment of choice in first-line treatment. Despite the effectiveness of these new treatments, all patients will virtually experience a relapse. There is no data on second-generation TKI-ALK resistance mechanisms when given as first-line treatment and the best therapeutic strategy for progression is undefined.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

From Development to Place in Therapy of Lorlatinib for the Treatment of ALK and ROS1 Rearranged Non-Small Cell Lung Cancer (NSCLC).
Fabbri L, Di Federico A, Astore M, Marchiori V, et al · · 2023 · cited 10× · PMID 38201357 · DOI 10.3390/diagnostics14010048
Sustained Improvement in the Management of Patients with Non-Small-Cell Lung Cancer (NSCLC) Harboring ALK Translocation: Where Are We Running?
Spitaleri G, Trillo Aliaga P, Attili I, Del Signore E, et al · · 2023 · cited 8× · PMID 37232842 · DOI 10.3390/curroncol30050384
Mechanisms of Resistance to ALK Inhibitors and Corresponding Treatment Strategies in Lung Cancer.
Xie J, Gao Y, Xu W, Zhu J. · · 2025 · cited 5× · PMID 40259931 · DOI 10.2147/ijgm.s512395

Verify or expand the search:

Other trials of Lorlatinib

Trials testing the same drug.

NCT07415005 — Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
NCT06678555 — A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out. · active not recruiting
NCT06487078 — Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World C · NA · recruiting
NCT06282874 — Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases · Phase 4 · active not recruiting

Other recruiting trials for Non Small Cell Lung Cancer Metastatic

Currently open trials in the same condition.

NCT06917573 — PALACE: Cemiplimab Trial According to ctDNA Levels · Phase 2 · recruiting
NCT07190677 — First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial · recruiting
NCT06473961 — A Phase Ib Study of GC101 in NSCLC · Phase 1 · recruiting
NCT05864794 — Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer · NA · recruiting
NCT05853887 — Liquid Biopsy Based NGS in Newly Diagnosed NSCLC · NA · active not recruiting

Other Intergroupe Francophone de Cancerologie Thoracique trials

Trials by the same sponsor.

NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
NCT06937905 — Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic P · Phase 3 · recruiting
NCT06908993 — Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Trea · Phase 3 · recruiting
NCT06840834 — Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previo · Phase 2 · recruiting
NCT05285033 — RW Effectiveness of Lurbinectedin in Extensive Stage SCLC · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04111705 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Intergroupe Francophone de Cancerologie Thoracique
Last refreshed: 1 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04111705.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing