NCT06682884Not yet recruitingPhase 2
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 · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06682884
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 15 Nov 2024 to the primary completion date, 30 Apr 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any systemic anti-cancer therapy for locally advanced NSCLC
Other illness
- Mixed squamous cell carcinoma, large cell carcinoma, small cell lung cancer.
- Unable to tolerate curative surgery per anaesthesiologist evaluation.History of organ transplant.
- 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;
Other
- Non-resectable stage IB, II, IIIA or selected IIIB NSCLC evaluated by thoracic surgeons.
- Pregnant or lactating, or intending to become pregnant during the study
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.