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Report for Clinical Trial NCT02788058

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02788058 Lung Adenocarcinoma EGFR Positive Non-small Cell Lung Cancer
MeSH:Adenocarcinoma Adenocarcinoma of Lung

2 Interventions

Name: EGFR-TKI

Description: Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
Type: Drug
Group Labels: 2

EGFR-TKI EGFR-TKI+hypofractionated radiotherapy

Name: Thoracic Hypofractionated Radiotherapy

Description: 40-45 Gy/5-15f
Type: Radiation
Group Labels: 1

EGFR-TKI+hypofractionated radiotherapy


Primary Outcomes

Measure: Progression free survival

Time: 3 years

Secondary Outcomes

Measure: Frequency of T790M mutation before treatment detected by ctDNA

Time: 1 months

Measure: Abundance of T790M mutation before treatment detected by ctDNA

Time: 1 months

Measure: Frequency of T790M mutation after radiotherapy detected by ctDNA

Time: 3 months

Measure: Abundance of T790M mutation after radiotherapy detected by ctDNA

Time: 3 months

Measure: Frequency of T790M mutation after 1 year detected by ctDNA

Time: 1 year

Measure: Abundance of T790M mutation after 1 year detected by ctDNA

Time: 1 year

Description: We will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy.

Measure: Rate of CTCAE grade 2 or higher radiation pneumonitis

Time: 1 years

Description: FACT-E score at the 4 months after docetaxel consolidation therapy

Measure: To assess the short-term quality of life (QOL)

Time: 4 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

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. --- L858R ---


2 T790M

Frequency of T790M mutation before treatment detected by ctDNA. --- T790M ---

Abundance of T790M mutation before treatment detected by ctDNA. --- T790M ---

Frequency of T790M mutation after radiotherapy detected by ctDNA. --- T790M ---

Abundance of T790M mutation after radiotherapy detected by ctDNA. --- T790M ---

Frequency of T790M mutation after 1 year detected by ctDNA. --- T790M ---

Abundance of T790M mutation after 1 year detected by ctDNA. --- T790M ---

Two reasons can be used to explain the formation of the residual lesion:1)there is a subgroup of cancer cells that are not sensitive to TKI therapy because of tumor heterogeneity, like de novo T790M mutation; 2)some cancer cells can keep static state during the beginning treatment, and then develops acquired resistance to TKI therapy under the long-term drug pressure and continue to re-proliferation. --- T790M ---



HPO Nodes