SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02416739

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Randomized Double-blinded Comparative Trial to Study the Add-on Activity of Combination Treatment of Nicotinamide on Progression Free Survival for EGFR Mutated Lung Cancer Terminal Stage Patients Being Treated With Gefitinib or Erlotinib

Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer cells. Nicotinamide was found to be effective in several animal cancer models including lung, bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is also effective in the treatment of human lung cancer.

NCT02416739 Non-Small-Cell Lung Carcinoma
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Nicotinamide

Description: Nicotinamide (1g/day) or placebo treatment is added to the standard drug treatment (gefitinib or erlotinib) to EGFR mutated NSCLC patients

Type: Drug

Nicotinamide Placebo


Primary Outcomes

Description: Cox regression analysis

Measure: Hazard ratio (PFS) of the nicotinamide arm to the placebo arm

Time: two year

Secondary Outcomes

Description: chi-square test of complete response and partial response (RECIST 1.1)

Measure: Response rate

Time: two year

Description: measured by the cancer-related QOL questionaire response (questioned at each visit)

Measure: Difference in quality of life between the nicotinamide arm and the placebo arm

Time: two year

Description: Cox regression analysis

Measure: Overall survival

Time: two year

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: - Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy - EGFR mutated (exon 19 deletion or L858R mutation) - Life expectation more than 3 months - More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously - ECOG (Eastern Cooperative Oncology Group ) performance status grade 0~2 - Who signed the informed consent form Exclusion Criteria: - Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy - Who has metastasized brain lesion that needs operation or radiation therapy - Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney - Who does Not agree to contraception - Who has allergy to nicotinamide Inclusion Criteria: - Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy - EGFR mutated (exon 19 deletion or L858R mutation) - Life expectation more than 3 months - More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously - ECOG (Eastern Cooperative Oncology Group ) performance status grade 0~2 - Who signed the informed consent form Exclusion Criteria: - Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy - Who has metastasized brain lesion that needs operation or radiation therapy - Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney - Who does Not agree to contraception - Who has allergy to nicotinamide Non-Small-Cell Lung Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung The standard therapy to the EGFR (epidermal growth factor receptor) mutation positive non-small-cell lung cancer patients who are not eligible to operation is to administer EGFR-TKIs (tyrosine kinase inhibitors, gefitinib or erlotinib). --- L858R ---

Inclusion Criteria: - Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy - EGFR mutated (exon 19 deletion or L858R mutation) - Life expectation more than 3 months - More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously - ECOG (Eastern Cooperative Oncology Group ) performance status grade 0~2 - Who signed the informed consent form Exclusion Criteria: - Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy - Who has metastasized brain lesion that needs operation or radiation therapy - Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney - Who does Not agree to contraception - Who has allergy to nicotinamide Inclusion Criteria: - Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy - EGFR mutated (exon 19 deletion or L858R mutation) - Life expectation more than 3 months - More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously - ECOG (Eastern Cooperative Oncology Group ) performance status grade 0~2 - Who signed the informed consent form Exclusion Criteria: - Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy - Who has metastasized brain lesion that needs operation or radiation therapy - Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney - Who does Not agree to contraception - Who has allergy to nicotinamide Non-Small-Cell Lung Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung The standard therapy to the EGFR (epidermal growth factor receptor) mutation positive non-small-cell lung cancer patients who are not eligible to operation is to administer EGFR-TKIs (tyrosine kinase inhibitors, gefitinib or erlotinib). --- L858R --- --- 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