Using Lorlatinib to treat Stage III Non-small Cell Lung Cancer before surgery
Induction Lorlatinib for ALK Fusion Locally Advanced Non-small Cell Lung Cancer: A Prospective, Single Arm, Open-label Phase 2 Study
This study is testing if the drug Lorlatinib can help people with stage III non-small cell lung cancer that has an ALK fusion feel better before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Drugs / interventions | Lorlatinib, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05740943 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial evaluates the efficacy and safety of Lorlatinib as an induction treatment for patients with stage III non-small cell lung cancer (NSCLC) that harbors ALK fusion. Patients will receive three cycles of Lorlatinib and undergo a multidisciplinary assessment to determine eligibility for radical surgery or local radiotherapy. The study aims to assess the pathological complete response (pCR) rate and the feasibility of using dynamic ctDNA monitoring to guide treatment decisions. Following local intervention, patients may choose between continued Lorlatinib treatment or adjuvant chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with stage III NSCLC harboring ALK fusion and meeting specific health criteria.
Not a fit: Patients with stage III NSCLC who do not have ALK fusion or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and overall survival for patients with stage III NSCLC.
How similar studies have performed: Other studies have shown promising results with similar induction therapies in NSCLC, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Stage I, stage II and metastatic stage IV NSCLC; * Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer); * Patients who have previously used any other anti-tumor drugs or received surgery/radiotherapy; * Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections. * 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; * Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; * Patients with low compliance or willingness to take the drugs and surveillance.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Wen-Zhao Zhong, MD. — Guangdong Provincial People's Hospital
- Study coordinator: Wen-Zhao Zhong, MD.
- Email: 13609777314@163.com
- Phone: 86-13609777314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.