NCT05740943Active, not recruitingPhase 2
Induction Lorlatinib in Stage III Non-small Cell Lung Cancer
Induction Lorlatinib for ALK Fusion Locally Advanced Non-small Cell Lung Cancer: A Prospective, Single Arm, Open-label Phase 2 Study
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
A prospective, single-arm, open-label phase 2 study that evaluates the efficacy and safety of induction Lorlatinib in stage III non-small cell lung cancer and explores the clinical feasibility of dynamic ctDNA and multidisciplinary assessment in guiding local treatments.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 12 Feb 2023
- Start date
- 15 Mar 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Guangdong Provincial People's Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05740943
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 15 Mar 2023 to the primary completion date, 31 Dec 2025
- 4 sites in 1 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
- Patients who have previously used any other anti-tumor drugs or received surgery/radiotherapy;
- Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
- Patients with low compliance or willingness to take the drugs and surveillance.
Other illness
- Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections.
Other
- Stage I, stage II and metastatic stage IV NSCLC;
- Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;
Who the study is looking for
- Age :18 Years to 75 Years;
- ECOG physical score 0-2 points; expected survival time ≥ 1 year;
- Pathologically confirmed diagnosis with Stage III NSCLC which harbored ALK fusion detected by next generation sequencing (NGS) or immunohistochemistry (IHC) with or without FISH. Suspected N2 (station 2/4/7) for stage III disease should be confirmed by either mediastinoscopy or EBUS.
- At least one measurable target lesion according to the RECIST 1.1 standard;
- The main organ function meets the following criteria: 1) blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L; 2) blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
- Subjects voluntarily joined the study and signed informed consent, with good compliance to follow-up.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijin | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Guangzhou Twelfth People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.