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NCT06682884: NEOLORA

Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer

Not yet recruiting Phase 2 Last updated 12 November 2024
What this trial tests

Phase 2 trial testing Lorlatinib 100 mg in Neoadjuvant Non-Small Cell Lung Cancer in 25 participants. Not yet recruiting.

Timeline
15 November 2024
Primary endpoint
30 April 2026
31 May 2027

Quick facts

Lead sponsorPeking University People's Hospital
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date15 November 2024
Primary completion30 April 2026
Estimated completion31 May 2027

Drugs / interventions tested

Conditions studied

Sponsor

Peking University People's Hospital

Who can join

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

Sponsor's own description

This project was designed To explore the pathological complete response (pCR) of lorlatinib as neoadjuvant treatment. Twenty-five patients will be involved in this study. These patients will receive lorlatinib neoadjuvant therapy for 6-8 weeks (determined by clinicians' decision based on clinical practice) and then underwent surgery. Previous small-sample clinical studies on ALK inhibitors as neoadjuvant therapy in resectable NSCLC have shown promising outcomes including MPR and pCR, supporting the potential of ALK TKIs in this setting.

Publications & conference data

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

  1. Perioperative Therapy in Oncogene-Driven Non-Small Cell Lung Cancer: Current Strategies and Unanswered Questions.
    Voruganti T, Marar R, Bleiberg B, Garbo E, et al · · 2025 · cited 2× · PMID 40311093 · DOI 10.1200/edbk-25-472804
  2. Neoadjuvant, Adjuvant and Perioperative Treatment in Early-Stage Non-Small Cell Lung Cancer (NSCLC) with Actionable Genomic Alterations: Current Landscape and Future Perspectives.
    Koutoukoglou P, Mountzios G. · · 2026 · PMID 41681965 · DOI 10.3390/cancers18030493
  3. A Canadian Perspective on Perioperative Systemic Therapy in Resectable Non-Small Cell Lung Cancer.
    Khan SR, Kotrri E, Breadner D, Kundapur V, et al · · 2025 · PMID 41590340 · DOI 10.3390/curroncol33010020

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Other trials of Lorlatinib 100 mg

Trials testing the same drug.

Other Peking University People's Hospital trials

Trials by the same sponsor.

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Data sources for this page

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/NCT06682884.

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