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Phase IV clinical trial for alectinib as first-line treatment of advanced non-small cell lung cancer with positive ALK gene.

Phase IV clinical trial for alectinib as first-line treatment of advanced non-small cell lung cancer with positive ALK gene.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031670
Enrollment
Unknown
Registered
2020-04-06
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced non-small cell lung cancer with positive ALK gene.

Interventions

Case series:Alectinib

Sponsors

Department of Oncology, Maoming People's Hospital, Guangdong Province, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patient aged 18-75 years; 2. PS0-2; 3. Patients with non-small cell lung cancer confirmed by histology or cytology and alk mutation detected; 4. Patients with a life expectancy greater than 12 weeks; 5. Patients willing to sign informed consent; 6. Patients with assessable lesions in the lung or in the metastatic site, the largest lesion is greater than 1 cm; 7. Patients who can follow the research and follow-up procedure.

Exclusion criteria

Exclusion criteria: 1. Patients with any unstable systemic diseases (including active infection, poor control of hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic diseases); 2. Patients who have received systematic anti-tumor treatment with ALK inhibitors before treatment; 3. Patients who received radiotherapy for brain metastasis; 4. Any obvious eye abnormality, especially severe dry eye syndrome, dry keratoconjunctivitis, severe exposure keratitis or other diseases that may increase epithelial damage; 5. Patients who are unable to receive oral administration, need intravenous high-energy nutrition, have previously had surgery affecting absorption or have active peptic ulcer; 6. Lactating women; 7. Patients with granulocyte count less than 1.5*10^9/L and platelet count less than 75*10^9/L; 8. Patients whose serum bilirubin is 1.5 ULN; 9. AST and ALT were more than 2 ULN, and 5 ULN in case of liver metastasis. Serum creatinine was 1.5 ULN, or creatinine clearance rate was less than 50ml/min.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactHuang Yisheng

Maoming People's Hospital of Guangdong Province, China

hysd999@hotmail.com+86 13719211288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026