SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03117049

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1