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Report for Clinical Trial NCT03647956

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Atezolizumab in Combination With Bevacizumab, Carboplatin and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors: a Single Arm Phase 2 Study

This project will recruit 40 EGFR-mutant metastatic non-small cell lung cancer patients who failed any EGFR tyrosine kinase inhibitors. All recruited patients will receive 1200mg Azetolizumab administered over 60 minutes (1st cycle) and 30 minutes (2nd cycle onwards) intravenously, as well as 7.5mg/kg bevacizumab administered over 90 minutes (1st cycle), 60 minutes (2nd cycle) and 30 minutes (3rd cycle onwards) for every 3 weeks, until radiographically documented disease progression, unacceptable toxicity as judged by investigators or patient withdrawal. The primary objective is to assess the progression-free survival of this treatment population, and to identify potential genomic and immunologic biomarkers for treatment response. Objective response rate (ORR) will be the primary efficacy endpoint.

NCT03647956 NSCLC Stage IIIB NSCLC Stage IV EGFR Activating Mutation
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

4 Interventions

Name: Atezolizumab

Description: Atezolizumab (trade name Tecentriq) is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1).
Type: Drug
Group Labels: 1

Arm 1

Name: Bevacizumab

Description: Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A).
Type: Drug
Group Labels: 1

Arm 1

Name: Carboplatin

Description: Carboplatin, sold under the trade name Paraplatin among others, is a chemotherapy medication used to treat a number of forms of cancer.
Type: Drug
Group Labels: 1

Arm 1

Name: Pemetrexed

Description: Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.
Type: Drug
Group Labels: 1

Arm 1


Primary Outcomes

Description: The percentage of patients with radiologically complete or partial response as determined by the investigator according to RECIST version 1.1.

Measure: Objective response rate (ORR)

Time: 3 years

Secondary Outcomes

Description: PFS is measured from the date of study enrollment to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.

Measure: Progression-free Survival (PFS)

Time: 3 years

Description: TTP is measured from the date of study enrollment to radiographically documented progression according to RECIST 1.1. This does not include death from any cause.

Measure: Time to progression (TTP)

Time: 3 years

Measure: Duration of response (DoR)

Time: 3 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

The use of neoadjuvant or adjuvant platinum-based chemotherapy more than 6 months before study enrollment is allowed - Previous exposure to VEGF inhibitor for anti-cancer treatment - Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PDL2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms - Patients carries EGFR genotype T790M but have not received 3rd generation EGFR TKI Osimertinib - Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of atezolizumab - Expected to require any other form of antineoplastic therapy while on study - Patients with untreated symptomatic brain metastases. --- T790M ---



HPO Nodes


HPO: