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Report for Clinical Trial NCT04099836

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Single Arm Phase 2 Trial of Atezolizumab and Bevacizumab in Epidermal Growth Factor Receptor (EGFR) Mutant Non‐Small Cell Lung Cancer in Patients With Progressive Disease After Receiving Osimertinib (TOP 1901)

The purpose of this study is to investigate the safety and efficacy of giving atezolizumab combined with bevacizumab in patients with stage 4 epidermal growth factor receptor (EGFR) mutant non‐small cell lung cancer (NSCLC) whose cancer has gotten worse while receiving osimertinib.

NCT04099836 Non Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Disease Progression
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Atezolizumab

Description: 1200 mg IV
Type: Drug
Group Labels: 1

atezolizumab and bevacizumab

Name: Bevacizumab

Description: 15 mg/kg IV
Type: Drug
Group Labels: 1

atezolizumab and bevacizumab


Primary Outcomes

Description: RECIST 1.1 will be used to measure confirmed partial or complete responses to the study drug.

Measure: Objective response rate (ORR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors RECIST 1.1 (brand name)

Time: Up to 3 years

Secondary Outcomes

Description: Progression will be defined as time from start of study therapy to disease progression or death

Measure: Progression free survival as measured by Response Evaluation Criteria In Solid Tumors RECIST 1.1 (brand name) as assessed by the investigator.

Time: Up to 5 years

Description: Overall survival (OS) is defined as the time from start of study therapy to death from any cause, and patients who are alive at the time of analysis will be censored at the last date of contact.

Measure: Overall survival as noted by follow-up via composite of telephone or medical record review.

Time: Up to 3 years

Description: Evaluation of safety using the National Cancer Institute (NCI) CTCAE version 4.03

Measure: AEs as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Time: Up to 5 years]

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: 1. Age ≥18 years 2. Histologic documentation of primary lung carcinoma, non‐squamous histology with EGFR exon deletion 19 or exon 21 L858R mutation 3. Stage IV disease according to the 8th Edition of the American Joint Committee on Cancer staging system 4. Disease progression on osimertinib 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 (appendix 1) 6. Measureable disease as defined by RECIST 1.1 (appendix 2) 7. The following laboratory values obtained ≤ 30 days prior to starting study therapy 1. ANC ≥ 1, 500 / mm3 2. Platelet count, ≥ 100,000 / mm3 3. Hemoglobin ≥ 9.0 g / dL 4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) 5. Serum Glutamic Oxaloacetic Transaminase (SGOT) (Aspartate Aminotransferase, AST) and Serum Glutamic Pyruvic Transaminase (SGPT) (Alanine Aminotransferase, ALT) ≤2.5 x ULN in patients without liver or bone metastases; < 5 x ULN in patients with liver or bone metastases. --- L858R ---

Prior therapy with anti‐PD‐1 or anti‐PD‐L1 immunotherapy, 18. Prisoners, participants who are involuntarily incarcerated, or participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness Inclusion Criteria: 1. Age ≥18 years 2. Histologic documentation of primary lung carcinoma, non‐squamous histology with EGFR exon deletion 19 or exon 21 L858R mutation 3. Stage IV disease according to the 8th Edition of the American Joint Committee on Cancer staging system 4. Disease progression on osimertinib 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 (appendix 1) 6. Measureable disease as defined by RECIST 1.1 (appendix 2) 7. The following laboratory values obtained ≤ 30 days prior to starting study therapy 1. ANC ≥ 1, 500 / mm3 2. Platelet count, ≥ 100,000 / mm3 3. Hemoglobin ≥ 9.0 g / dL 4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) 5. Serum Glutamic Oxaloacetic Transaminase (SGOT) (Aspartate Aminotransferase, AST) and Serum Glutamic Pyruvic Transaminase (SGPT) (Alanine Aminotransferase, ALT) ≤2.5 x ULN in patients without liver or bone metastases; < 5 x ULN in patients with liver or bone metastases. --- L858R ---

Patients who have one of the following EGRF mutations: exon 19 or exon 21 L858R with progressive disease on osimertinib may be eligible to participate in this study. --- L858R ---



HPO Nodes


HPO: