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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

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

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

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

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

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:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1