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Report for Clinical Trial NCT03117049

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.

NCT03117049 Non-Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

5 Interventions

Name: ONO-4538

Description: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 1

ONO-4538 group

Name: Carboplatin

Description: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 2

ONO-4538 group Placebo group

Name: Paclitaxel

Description: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 2

ONO-4538 group Placebo group

Name: Bevacizumab

Description: Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 2

ONO-4538 group Placebo group

Name: Placebo

Description: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Type: Drug
Group Labels: 1

Placebo group


Primary Outcomes

Measure: Progression Free Survival (PFS) as assessed by the Independent Radiology Review Committee (IRRC)

Time: Up to approximately 3 years

Secondary Outcomes

Measure: Overall survival (OS)

Time: At least 3 years

Measure: PFS (as assessed by the study site's investigator)

Time: Up to approximately 3 years

Measure: Objective response rate (ORR [as assessed by the IRRC and study site's investigator])

Time: Up to approximately 3 years

Measure: Disease control rate (DCR [as assessed by the IRRC and study site's investigator])

Time: Up to approximately 3 years

Measure: Duration of response (DOR [as assessed by the IRRC])

Time: Up to approximately 3 years

Measure: Time to response (TTR [as assessed by the IRRC])

Time: Up to approximately 3 years

Measure: Best overall response (BOR [as assessed by the IRRC and study site's investigator])

Time: Up to approximately 3 years

Measure: Maximum percentage of change in the sum of diameters of target lesions (as assessed by the IRRC)

Time: Up to approximately 3 years

Measure: Safety will be analyzed through the incidence of adverse events, serious adverse events

Time: Up to 100 days from last dose

Measure: Patient reported outcome (PRO)

Time: Up to approximately 5 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 Exclusion Criteria: - Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R) substitution mutations. --- L858R ---



HPO Nodes


HPO: