SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04194203

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase III, Randomized, Double-Blind Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)

This study will evaluate the efficacy and safety of atezolizumab when given in combination with bevacizumab, investigator's choice of either paclitaxel or pemetrexed, and carboplatin compared with placebo given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with chemotherapy-naive, Stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase.

NCT04194203 Carcinoma, Non-Small-Cell Lung
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

6 Interventions

Name: Atezolizumab

Description: Atezolizumab will be administered by IV infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Type: Drug
Group Labels: 1

Treatment A

Name: Placebo

Description: Placebo matching to atezolizumab will be administered by IV infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
Type: Drug
Group Labels: 1

Treatment B

Name: Bevacizumab

Description: Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Type: Drug
Group Labels: 2

Treatment A Treatment B

Name: Paclitaxel

Description: Paclitaxel will be administered by IV infusion at a dose of 175 mg/m2.
Type: Drug
Group Labels: 2

Treatment A Treatment B

Name: Pemetrexed

Description: Pemetrexed will be administered by IV infusion at a dose of 500 mg/m2.
Type: Drug
Group Labels: 2

Treatment A Treatment B

Name: Carboplatin

Description: Carboplatin will be administered by IV infusion to achieve an initial target AUC of 6 mg/mL/min.
Type: Drug
Group Labels: 2

Treatment A Treatment B


Primary Outcomes

Description: PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1

Measure: Progression Free Survival (PFS) in the intent to treat (ITT) population, as determined by the investigator

Time: Randomization until the first occurence of disease progression or death from any cause, whichever occures first (up to approximately 33 months)

Secondary Outcomes

Description: OS after randomization, defined as the time from randomization to death from any cause.

Measure: Overall Survival (OS) in the ITT population

Time: Randomization to death from any cause (up to approximately 33 months)

Description: PFS after randomizationdefined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the an Independent Review Facility (IRF) according to RECIST v1.1

Measure: PFS in the ITT population, as determined by IRF

Time: Randomization until the first occurence of disease progression or death from any cause, whichever occures first (up to approximately 33 months)

Description: PFS after randomization as determined by the investigator according to RECIST v1.1 in the subgroup of patients with PD-L1 expression defined by the SP263 immunohistochemistry (IHC) assay.

Measure: PFS in subgroup of participants with PD-L1 Expression, as determined by the investigator

Time: Randomization until the first occurence of disease progression or death from any cause, whichever occures first (up to approximately 33 months)

Description: PFS after randomization as determined by the investigator according to RECIST v1.1 in the subgroup of patients with genomic alterations in EGFR (i.e., sensitizing EGFR mutations) or ALK gene.

Measure: PFS in the subgroup of participants with genomic alterations in EGFR or ALK gene, as determined by the investigator

Time: Randomization until the first occurence of disease progression or death from any cause, whichever occures first (up to approximately 33 months)

Description: ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.

Measure: Objective Response Rate (ORR) in the ITT population

Time: Randomization until disease progression or death, which ever occurs first (up to approximately 33 months)

Description: DOR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

Measure: Duration of response (DOR) in the ITT population

Time: Randomization until the first occurence of a documented objective response to disease progression or death from any cause, whichever occures first (up to approximately 33 months)

Description: (TTD) in physical functioning, defined as the time from randomization to the first observed >=10-point decrease in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) for cancer linearly transformed physical functioning scale score that is sustained for two consecutive assessments or followed by death while the patient is on study treatment.

Measure: Time to Deterioration (TTD) in physical functioning in the ITT population

Time: Randomization up until approximately 33 months

Measure: Percentage of Participants With Adverse Events

Time: Randomization up to approximately 33 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and who have no evidence of the EGFR T790M mutation in the tumor tissue after TKI therapy are eligible. --- T790M ---

Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation in their tumor tissue must have also progressed on or were intolerant to osimertinib to be eligible. --- T790M ---



HPO Nodes


HPO: