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Report for Clinical Trial NCT01941654

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Single-arm Phase II Study to Determine the Efficacy of Preemptive Local Ablative Therapy to Residual Metabolic Active Oligo-metastases in Those EGFR Mutation Positive Non-small Cell Lung Cancer Patients Who Have Achieved a Good Partial Response With First-line EGFR TKI (ATOM)

To determine the efficacy of preemptive local ablative therapy in NSCLC patients with activating EGFR mutation who have oligometastatic residual metabolic-active disease after first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.

NCT01941654 NSCLC Activating EGFR Mutation

2 Interventions

Name: preemptive local ablative therapy

Type: Radiation
Group Labels: 1

preemptive local ablative therapy

Name: Oral TKI

Type: Drug
Group Labels: 1

preemptive local ablative therapy


Primary Outcomes

Measure: PFS rate at 1 year

Time: 2 years

Secondary Outcomes

Measure: Overall survival

Time: 2 years

Measure: Progression-free survival

Time: 2 years

Measure: radiologic change on PET-CT scan 3 months after SABR

Time: 3 months

Measure: Number of Participants with Adverse Events as a Measure of safety

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: 1. Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung 2. Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues 3. Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan 4. --- L858R ---

Non-compliance to the study procedure Inclusion Criteria: 1. Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung 2. Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues 3. Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan 4. --- L858R ---



HPO Nodes