A Study of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First People's Hospital of Hangzhou
• Treatments: Erlotinib Hydrochloride; Gefitinib

Criteria

Inclusion Criteria:

• Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and became oligometastatic disease after 3 months TKI, evaluated by PET/CT scan, brain MRI, and abdomen ultrasound (≤6 discrete lesions of disease, exclusive of the brain metastases, ≤3 lesions in the liver, ≤3 lesions in the lung);

• All sites of disease must be amenable to definitive RT;

• An intrathoracic lymph nodal station is considered 1 discrete lesion, according to IASLC lymph nodal station map;

• Age 18 years or older;

• ECOG Performance Status 0-2;

• Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal;

• For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment;

• Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter;

• Patients and their family signed the informed consents;

Exclusion Criteria:

• Received chemotherapy before TKI therapy;

• Brain parenchyma or leptomeningeal disease;

• Any site of disease that is not amenable to definitive RT;

• Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment;

• Any medical co-morbidities that would preclude radiation therapy.