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Report for Clinical Trial NCT03727867

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Ⅲ Phase Trial of Efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Combined With Early Stereotactic Body Radiation Therapy to the Primary Tumor in Advanced Non-small Cell Lung Cancer Patients Harboring Epidermal Growth Factor Receptor Mutation

Non-small cell lung cancer (NSCLC) is a prevalent disease with high mortality and morbidity, particularly of adenocarcinoma in Asians. Fortunately, with the development of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), treatment of lung cancer usher in a new era, resulting in a hit of precise therapy and molecule sequencing. However, it is inevitable for patients to gain acquired resistance of EGFR TKI. Several studies have been demonstrated that there were approximately 30% heterogeneous cells in primary tumors. And emerging studies illuminated that main pattern of treatment failure was the recurrence of primary site. Moreover, it was proved that despite of the drug-resistance cells in progressive site, continual prescription of EGFR TKI in oligometastasis lung cancer could make a difference for patients in progression free survival (PFS) and overall survival (OS), owing to the residual responsive cells in another sites. Therefore, to explore an unique method to control heterogeneous cells in primary site so as to delay or prevent acquired resistance when taking EGFR TKI orally may be of great benefit and therapy. It is known to all that stereotactic body radiation therapy (SBRT), with the advantage of hypofractionation and rapid release, succeed in several cancers, such as early lung cancer, prostatic, liver cancer and so on, for local control. Numerous reports explained SBRT played an irreplaceable role in progressive NSCLC patients after oral targeted medicine, regardless of EGFR or anaplastic lymphoma kinase (ALK) mutation. And the radiosensitivity of EGFR TKI in vitro and vivo may account for these inspiring results. What's more, it has reported that SBRT could induce inflammatory cell death, activate dendritic cell as well as accelerate antigen presentation in the draining lymph node, leading to antigen-specific adaptive immune response. Nevertheless, although the potential effects of SBRT on advanced NSCLC are obviously, few studies explore the preventive benefits of early SBRT combined with oral EGFR TKI on advanced lung cancer by eliminating the heterogeneous cells in primary site. In addition, the investigators' previous phase II study of SBRT combined with oral EGFR TKI had revealed its safety and potentially improvement of PFS for 6 months. In this trial, the investigators put sight into assessing the efficacy of early application of SBRT to primary site in the advanced NSCLC patients and provide a hypothesis that early SBRT could strengthen the anti-tumor effect of EGFR TKI through eradicating the heterogenity of initial tumor cells.

NCT03727867 Advanced Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor

Description: Oral EGFR TKI begins on day 1 and continues until disease progresses.
Type: Drug
Group Labels: 2

Drug group Drug plus SBRT group

Name: Stereotactic Body Radiation Therapy

Description: Participants were given Stereotactic Body Radiation Therapy in a dose of 60 Gy/8 fraction for the central tumor or 50 Gy/5 fraction for the peripheral lung cancer, respectively.
Type: Device
Group Labels: 1

Drug plus SBRT group

Primary Outcomes

Description: Evaluate the effect of EGFR TKI with or without SBRT on progression free survival.

Measure: Progression free survival

Time: Duration of time from the start of EGFR TKI therapy to the time of disease progression, assessed up to 3 years.

Secondary Outcomes

Description: To describe the rate of local control and out-of-field disease progression, irrespectively.

Measure: Local control rate (LCR)

Time: Up to 3 years.

Description: To evaluate overall survival in EGFR TKI therapy with SBRT in comparison to EGFR TKI therapy alone.

Measure: Overall survival

Time: Duration of time from the start of EGFR TKI therapy to 3 years or until time of death, whichever occurs first.

Description: The acute and chronic profile associated with the study regimen using CTCAE v5.0.

Measure: Adverse events

Time: Up to 3 years.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 L858R

exon 19 deletion or exon 21 L858R); 4. Estimated life expectancy >8 weeks; 5. Patients should have adequate bone marrow function defined as absolute peripheral granulocyte count (AGC) of >/= 1500 cells/mm3, platelet count of >/= 100000 cells/mm3; adequate hepatic function with bilirubin /= 50 ml/min and international normalized ration (INR) 0.8-1.2; --- L858R ---

HPO Nodes