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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

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
BeijinChinaUnknown status
The Second Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Guangzhou Twelfth People's Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Guangdong Provincial People's Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.