Clinical trial · Interventional
Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer
Phase II, Open-label, Single-arm, Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Lorlatinib as Neoadjuvant Treatment in Surgically Resectable Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer (NEOLORA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lorlatinib 100 mg | Drug | Lorlatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lorlatinib as Neoadjuvant Treatment
- description
- These patients will receive lorlatinib neoadjuvant therapy for 6-8 weeks (determined by clinicians' decision based on clinical practice) and then underwent surgery
- interventionNames
- Drug: Lorlatinib 100 mg
Primary outcomes (1)
- measure
- Pathologic Complete Response (pCR) Rate
- timeFrame
- Within 1 month after surgery
- description
- Pathologic complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in lung primary or lymph nodes as evaluated by systematic pathological review of surgical specimens.
Secondary outcomes (6)
- measure
- Objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 years * Imaging confirmed, resectable stage IB, II, IIIA or selected IIIB (including T4N2,per AJCC 8th edition) * Histologically/cytologically confirmed lung adenocarcinoma * Documented ALK-rearrangement mutation positive (assessed by a local laboratory) * ECOG PS 0-1 * Patients must be treatment-naive for NSCLC and eligible to receive treatment with Lorlatinb. * Measurable disease, as defined by RECIST v1.1 * Hematology, liver and kidney function are adequate for neoadjuvant therapy. * Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis). * Male participants must be willing to use acceptable methods of contraception. * Female participants of childbearing potential must agree to use acceptable methods of contraception. * Ability to provide written informed consent. Exclusion Criteria: * Mixed squamous cell carcinoma, large cell carcinoma, small cell lung cancer. * Prior treatment with any systemic anti-cancer therapy for locally advanced NSCLC * Non-resectable stage IB, II, IIIA or selected IIIB NSCLC evaluated by thoracic surgeons. * Unable to tolerate curative surgery per anaesthesiologist evaluation.History of organ transplant. * Pregnant or lactating, or intending to become pregnant during the study * Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol. * Past medical history of Interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. * A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; * Judgement by investigator that the subject should not participate in the study if the subject is unlikely to comply with the study procedures, restrictions and requirements.
References
Publications (1)
- BACKGROUNDShaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. doi: 10.1016/S1470-2045(17)30680-0. Epub 2017 Oct 23. PMID 29074098