ALK-positive initial unresectable locally advanced or metastatic NSCLC
Conditions
Interventions
Observation group:None
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years; ECOG performance status: 0–1; expected survival of more than three months; 2.Histologically or cytologically confirmed as non-small cell lung cancer; 3.The initial diagnosis stage belongs to locally advanced or metastatic non-small cell lung cancer. 4.Patients judged to be initially unresectable for curative intent, including but not limited to the following: those with tumors located close to the pleura, major blood vessels, or involving the esophagus, heart, etc., resulting in high surgical risk; those with single-station N2 mediastinal lymph nodes with short diameter >=3 cm, or multiple stations of lymphadenopathy, or fused lymph nodes; all N3 patients, etc. 5.Diagnosed as ALK mutation positive; 6.Previously untreated with systemic therapy (patients who have received one cycle of ALK inhibitor therapy may be retrospectively enrolled); 7.Normal literacy with sound cognitive and behavioral abilities; 8.The subject voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with a pathological diagnosis of small cell lung cancer; 2.A history of interstitial lung disease, drug-induced interstitial lung disease, or any clinically evident active interstitial lung disease; idiopathic pulmonary fibrosis identified on CT scan at baseline; 3.Any unstable systemic disease (including active infection, stage III hypertension, unstable angina, congestive heart failure, or hepatic, renal, or metabolic disorders); 4.Known or suspected allergy to brigatinib or its excipients; 5.Suffering from malabsorption syndrome or other gastrointestinal (GI) diseases or conditions; 6.Exclude females who are pregnant (positive pregnancy test within 7 days prior to enrollment) or breastfeeding; women of childbearing potential must commit to strict contraception during the study period and for 6 months after the study ends. 7.According to the researcher's judgment, subjects with concomitant diseases that pose a serious risk to the subject's safety or may affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival period;Depth of Response;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactHualin Chen
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed