SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02743923

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Chemotherapy in KRAS Mutated Chemotherapy Naive Non-small Cell Lung Cancer Patients: a Phase III Study Comparing Cisplatin-pemetrexed With Carboplatin-paclitaxel-bevacizumab: NVALT 22

The purpose of this study is to determine whether carboplatin-paclitaxel-bevacizumab results in a prolonged progression free survival compared to cisplatin-pemetrexed as first line treatment in patients with KRAS mutated non-small cell lung cancer.

NCT02743923 Carcinoma, Non-Small Cell Lung
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

5 Interventions

Name: carboplatin

Description: AUC 6

Type: Drug

carboplatin-paclitaxel- bevacizumab

Name: paclitaxel

Description: 200mg/m2

Type: Drug

carboplatin-paclitaxel- bevacizumab

Name: Bevacizumab

Description: 15 mg/kg

Type: Drug

carboplatin-paclitaxel- bevacizumab

Name: Pemetrexed

Description: 500 mg/m2

Type: Drug

cisplatin-pemetrexed

Name: cisplatin

Description: 75 mg/m2

Type: Drug

cisplatin-pemetrexed


Primary Outcomes

Measure: progression free survival

Time: Every 6 weeks, from date of randomization until the date of progression of disease or of death from any cause, assessed up to 60 months

Secondary Outcomes

Measure: disease control rate

Time: Every 6 weeks, from date of randomization until the date of progression of disease or of death from any cause, assessed up to 60 months.

Description: Stratification for KRAS mutation (G12V versus G12C versus other)

Measure: overall survival

Time: date of randomization to the date of death from any cause, assessed up to 60 months.

Description: The two most common KRAS types are G12C in about 40% of cases, G12V in 18% and G12D in 15% of cases. Subgroup analyses are planned to explore treatment effect in these different KRAS mutations groups. At baseline the metastatic patterns of these subgroups will be described. KRAS mutations in NSCLC occur mainly in codon 12 and 13. Stratification for KRAS mutation (G12V versus G12C versus other) at randomization.

Measure: outcome between G12V versus G12C versus other subtypes of KRAS mutations (mutational analysis on plasma and blood platelets).

Time: date of randomization to the date of death from any cause, assessed up to 60 months.

Measure: response by Crabb criteria (if applicable)

Time: Every 6 weeks, from date of randomization until the date of progression of disease or of death from any cause, assessed up to 60 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 G12C

Stratification for KRAS mutation (G12V versus G12C versus other). --- G12V --- --- G12C ---

outcome between G12V versus G12C versus other subtypes of KRAS mutations (mutational analysis on plasma and blood platelets).. --- G12V --- --- G12C ---

The two most common KRAS types are G12C in about 40% of cases, G12V in 18% and G12D in 15% of cases. --- G12C ---

Stratification for KRAS mutation (G12V versus G12C versus other) at randomization.. response by Crabb criteria (if applicable). --- G12V --- --- G12C ---


2 G12D

The two most common KRAS types are G12C in about 40% of cases, G12V in 18% and G12D in 15% of cases. --- G12C --- --- G12V --- --- G12D ---


3 G12V

Stratification for KRAS mutation (G12V versus G12C versus other). --- G12V ---

outcome between G12V versus G12C versus other subtypes of KRAS mutations (mutational analysis on plasma and blood platelets).. --- G12V ---

The two most common KRAS types are G12C in about 40% of cases, G12V in 18% and G12D in 15% of cases. --- G12C --- --- G12V ---

Stratification for KRAS mutation (G12V versus G12C versus other) at randomization.. response by Crabb criteria (if applicable). --- G12V ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1