SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03402048

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Randomized Phase III Multicenter Trial of Customized Chemotherapy Versus Standard of Care for1st Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer

This is a randomized phase III trial that will randomize elderly patients(70 years of age and older) who are not considered eligible for standard doublet or triplet regimens. In a 2:1 fashion, patients will be randomized to the customization arm or the standard arm, respectively. This trial will be offered to patients who are previously untreated for stage IV NSCLC. The primary objective is to evaluate if chemotherapy selection based on histology and tumoral molecular determinants ERCC1, RRM1 and TS (arm A, the experimental arm) results in superior outcome in elderly patients with untreated, advanced NSCLC compared to standard of care treatments (arm B, the standard arm).

NCT03402048 Stage IV, NSCLC Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms
MeSH: Neoplasms Lung Diseases Lung Neoplasms Respiratory Tract Diseases Thoracic Neoplasms Respiratory Tract Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic
HPO: Abnormal lung morphology Bronchial neoplasm Neoplasm Neoplasm of the lung Neoplasm of the respiratory system

5 Interventions

Name: Carboplatin

Type: Drug

control arm experimental arm

Name: Gemcitabine

Type: Drug

control arm experimental arm

Name: Pemetrexed

Type: Drug

control arm experimental arm

Name: Docetaxel

Type: Drug

control arm experimental arm

Name: Vinorelbine

Type: Drug

control arm experimental arm


Primary Outcomes

Description: primary endpoint is OS (determined from the date of randomization).Assuming an exponential survival distribution for both treatment arms and a median survival time of 8 months in the control arm we anticipate to detect an improvement of three months in OS.

Measure: Overall Survival

Time: from the date of randomization

Secondary Outcomes

Description: PFS at 6 months (determined from the date of randomization). The anticipated 6-month PFS in arm B is approximately 25% and the goal in the experimental arm is to achieve a 32% improvement to 33%.

Measure: Progression Free survival

Time: at six months determined from the date of randomization

Other Outcomes

Description: adverse events and serious adverse events as a measure of safety and tolerability

Measure: AE and SAE (according to CTCAE version 4.0)

Time: every week from the day 1 treatment until the end of treatment (up to 18 weeks)

Description: Rate of successfully conducted gene expression analysis in patients that have signed the informed consent document

Measure: Rate of successfully conducted gene expression analysis in patients that have signed the informed consent document

Time: up to10 business days of submission of the tumor specimen

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

T790M and D770. --- T790M ---



HPO Nodes


HPO:
Abnormal lung morphology
Genes 786
NHLRC1 EPHB4 MKKS ERBB2 SLC29A3 ERCC2 ABCA3 DGCR6 GLDN ERCC3 LZTR1 ABL1 ESS2 RNF168 ERF ZMPSTE24 MANBA AICDA PYROXD1 MARS USP9X SLC35C1 MAT2A TRAIP ACP5 NCF1 ACTA1 ACTA2 ETFA ETFB KIAA0319L ETFDH NAA10 CCNO TCIRG1 EVC MMP21 MCM4 IKZF1 EWSR1 CD46 KLHL41 TMEM173 RRAS ACVRL1 RREB1 ARID1A ADA COLQ IL17F MECP2 KLRC4 IFT43 MYSM1 NME8 MEFV RYR1 STN1 TBC1D24 BAP1 CDC45 GREB1L CITED2 FANCB ARID1B SAMD9L FBN1 PANK2 SFTPA2 KITLG MBTPS2 MGP AARS2 ZMYND10 CIITA FCGR3A ARHGAP31 AGA JAG1 AGT AGTR1 MIF MITF GPC4 SCN9A SCN10A SCNN1A SCNN1B WDR35 EMG1 SCNN1G CC2D2A AK2 SFTPA1 AKT1 NOP10 FGFR1 FGFR3 IFT80 PWAR1 PRKAG2 DOCK6 LTBP4 RSPH9 ALOX12B FOXF1 ALPL CRTAP FOXE3 FOXC2 FOXE1 FLI1 FLNA FLNB FRAS1 CLCA4 FBLN5 FMO3 CCDC22 LAMTOR2 OFD1 SFTPB SFTPC CTC1 PUF60 SGCG SGSH KLHL40 IFT81 SLC35A1 ITGA8 IKBKG ELP1 FUZ SLC34A2 BIRC3 XIAP LIPN CHD7 APOE AP3B1 FAS FCN3 NHP2 FASLG EPG5 MSN SDR9C7 WDR19 MST1 DNAI1 NPHP3 PIEZO2 TNFSF11 ARSB SLC11A1 G6PC3 ARVCF DYNC2LI1 MTHFD1 ASAH1 SLC18A3 SLC25A1 RFXANK SLCO2A1 DLL3 FSHR SNAI2 SMARCA4 RSPO2 SMARCB1 FLCN SMARCC2 SMARCD2 SMARCE1 FOXP1 SMN1 C11ORF95 CARD11 SMPD1 MESP2 NR5A1 FUCA1 ATM NGLY1 SNAP25 TBC1D23 MCTP2 SNRPN MUSK ATP5F1A GAA H19 AFF4 INVS MASP2 SON DNAH11 SOS1 SOS2 SNORD115-1 TRAF3IP2 MYD88 SOX10 SOX11 STK36 MYH3 INTU MYH7 SPAG1 MYH11 EOGT MYL2 DIS3L2 GALNS MYLK RIPK1 SPINK1 KIF1A MYO5A CHST14 TNFSF12 RTEL1 ERAP1 MYO9A JAGN1 MYOD1 NADK2 SDCCAG8 B2M PKD1L1 NAGLU GAS8 MAP3K20 GATA2 GATA4 GATA6 FADD GBA PWRN1 SRP54 NBN DRC1 SIK1 NCF2 NCF4 SLC46A1 CCND1 BCL2 NDN TNFRSF11A BCL6 NEB GDF1 BCR GPKOW GFI1 STAT1 CFB STAT3 STAT4 BGN STAT5B SLC52A3 BLM IFIH1 DNAAF3 STK11 MALT1 NEK1 BMPR2 STX1A GLA GPC3 GLB1 BRAF BRCA2 SULT2B1 NFE2L2 GLE1 GLI1 NFIX GLI3 NFKB1 BTK NFKB2 NFKBIA HES7 BUB1 VAMP1 BUB1B VPS13A LRRC56 HYLS1 KIAA0556 C4A TRPV3 ATP11A BCL10 TAF1 BMPER HERC2 STRA6 MYRF TAP1 TAP2 TAPBP AP3D1 GNS CFAP410 NOTCH1 TBX1 NOTCH2 NOTCH3 TBCE GP1BB PNP SPINK5 TBX5 TBX6 NPM1 CACNA1C TCF4 NIPAL4 TCF3 CARMIL2 NRAS GPR35 DOK7 ROR2 DDR2 NUMA1 NUP88 HGSNAT BAZ1B CASP8 OAS1 CASP10 MUC5B IL17RC RIPK4 OCRL SYT2 SPECC1L CAV1 RUNX2 SLC7A7 NSMCE3 CBL TERC CHAMP1 SERPINH1 TERT NXN DICER1 NR2F2 POLR3A TFRC TGFB1 GRIP1 TGFB2 TGFB3 UNC119 TGFBR1 TGFBR2 SLC22A18 LMOD3 TGM1 CORO1A GTF2E2 CD3D CD3E CD3G GTF2I CD8A DPP9 CD19 MS4A1 DCLRE1C ZNF341 NKX2-1 IL12A-AS1 CD28 TK2 GUSB BTNL2 SCARB2 TLR4 DNAI2 TNFRSF13C LRRC8A TNFRSF13B CD79A CD79B CD81 PRKN PARN HABP2 PAX3 PAX6 SPIDR LRBA TNFRSF1A TNFRSF1B BUB3 DNAAF1 KAT6B AGRN HACD1 TP53 ATP6V0A2 BMP15 PCNT HELLS TPM2 TPM3 CFH PIGN HFE TPP2 SCN11A POU6F2 CFAP300 HLA-B PDGFRA PDGFRB HLA-DPA1 ORC6 HLA-DPB1 CCDC114 CTSC HLA-DRB1 CFTR TRPS1 PEPD BLNK SLC5A7 PEX1 CLEC7A SOX18 PEX13 CHAT TSC1 TSC2 LRRC6 WNT4 TRIP13 TRIP11 LYST CHRM3 TRIP4 ZNHIT3 CHRNA1 PGM3 CHRND CHRNG HIRA RNU4ATAC TYK2 SLC2A10 CRELD1 SERPINA1 ICOS CLCN7 HOXD13 PIK3CA PIK3CD PIK3R1 HPGD EDARADD RAB3GAP2 HPS1 UFD1 A2ML1 NPAP1 SNX10 HRAS PKHD1 PSMC3IP GTF2H5 UMPS CCR1 UNG CCR6 IL17RA DGCR8 PLCG2 PLEC PLG SERPINF2 PLOD1 PLP1 KDM6A NIPBL CCDC151 ALG12 COG4 PML COL1A1 PMM2 COL2A1 COL3A1 VHL SLC25A24 COL5A1 COL5A2 COL6A1 HSPG2 COL6A2 COL6A3 PIGL PSAT1 EXOSC9 COL11A2 MAGEL2 COL13A1 DONSON WAS COMT CCDC103 WIPF1 TAPT1 ADAMTS3 ADAMTS2 CLIP2 DLL4 NSD2 NELFA MAP3K8 POLA1 WNT3 POLE GNPTAB EFEMP2 WRN IRF8 WT1 PORCN MINPP1 NABP1 GTF2IRD1 IDUA CFI CR2 LGI4 SP110 CREBBP CFAP298 ZAP70 CRKL PPP1CB DNAH1 IFNGR1 PPP2R1B BCL11B CSF2RA CSF2RB SEC24C IGH LACC1 NEK8 IGHM IL21R SETBP1 RBPJ LPIN2 MPLKIP PRKAR1A NKX2-5 CYP4F22 PRKCD CCN2 CTLA4 IGLL1 PRKDC PRKG1 MAPK1 IKBKB IL1RN CEP57 CCDC65 IL2RA IL2RG HYDIN IL6 IL7R CYBA PRPS1 CYBB MKRN3 IL10 IL12A TCTN3 PRSS1 IFT140 ZBTB16 SAMD9 PRTN3 PLVAP PSAP INHBA ABCA12 TMEM94 MCIDAS RIPPLY2 IFT172 PIEZO1 INPPL1 CYBC1 RNF113A KIAA0586 VPS33A INSR CD55 IPW IRF1 PTPN22 IRF5 TTC25 NHLRC2 DNAL1 KEAP1 ITGA3 ITGA7 PTEN BCOR ACE NEK9 ZEB2 ZBTB24 PTH1R MRPS22 PHGDH SNORD116-1 MKS1 HELLPAR ITPR1 FAM111B NSDHL DNAJB13 TMEM260 JAK3 DNAAF5 FREM2 TIMM8A FAM20C PTPN11 CEP120 RNF125 ALMS1 CLPB RSPH1 TINF2 TECPR2 WASHC5 FGF20 CXCR4 KCNJ6 HPS4 DHCR7 DHCR24 NECTIN1 IL21 DKC1 ALDH18A1 FIP1L1 CDT1 DNAH5 DNASE1L3 RAB27A IL23R KIF11 CCDC40 DNMT3B FOXP3 KRAS SLC12A6 RAF1 RAG1 DGCR2 RAG2 FAT4 EPM2A EVC2 B3GLCT ITCH RAPSN RARA RARB RSPH4A RASA2 WDR34 NUP107 USB1 DSG1 RB1 DSP DOCK8 DYNC2H1 SLC26A2 DNAAF4 ASCC1 DVL3 LAMA2 AGGF1 FARSB WDR60 LAMB2 RELA RELB REN DPF2 LBR ARMC4 REST RET LCK RFC2 WRAP53 GPC6 CCNQ ECM1 SELENON TBL1XR1 RFX5 RFXAP GMNN JMJD1C LEP CCDC39 LEPR LETM1 LFNG EDNRB ADGRG6 MKRN3-AS1 CEP55 RIT1 TTC7A DNAAF2 SLC25A22 RMRP LIFR MFAP5 RASGRP1 MLXIPL LIG4 LIMK1 RSPH3 KMT2D FAM13A LMNA EGFR CDCA7 TRIM28 RCBTB1 VANGL1 CCBE1 LOX ARID2 IER3IP1 ALG9 HPS6 RLIM IRAK4 TTC21B EHMT1 ELANE TRPV4 UBAC2 PIH1D3 ALOXE3 EIF2AK4 ELN LTBP3 RPGR DCTN4 SH2D1A ENG CSPP1 TBL2 EP300 COQ7 RPL10 SMAD3 SMAD4
Bronchial neoplasm
Neoplasm
Genes 762
CDKN1A CDKN1B CDKN1C CDKN2A HFE CDKN2B CDKN2C GDF5 TSR2 CDKN2D H19-ICR TMEM67 RPL26 RPL27 TREX1 ASXL1 ERBB2 SCN11A POU6F2 ERCC2 RPL35A ERCC3 BRIP1 ERCC4 ABL1 ERCC5 CEBPA ERCC6 PDE6D GCM2 CEL PDGFB PDGFRA PDGFRL MNX1 PDGFRB LEMD3 ENPP1 CTSC ESR1 HLA-DRB1 SLC26A4 MAX APC2 RPS7 TMC6 TMEM216 TRPS1 ACTB RPS10 MC1R MC2R BLNK RPS14 RPS15A ACTG2 ETV6 TCIRG1 DNAJC21 EVC HMBS L2HGDH RPS17 MCM4 RPS19 RPS20 TSC1 TSC2 EWSR1 EXT1 EXT2 RPS24 RPS26 RPS27 ACVR1 EYA1 RPS28 RPS29 MAGT1 ACVRL1 MDH2 MDM2 ADA HNF4A ADAR TRIP13 LYST PICALM ALX4 F13A1 TERF2IP PHF21A F13B RYR1 MAP3K1 AXIN1 TBC1D24 AXIN2 BAP1 CHRNG TWIST1 MEN1 TNFRSF4 FANCA FANCC FANCD2 FANCE TYR GFI1B FAH MET TYROBP FANCB FANCF FANCG SERPINA1 ARID1B SAMD9L AP2S1 MGAT2 DLC1 ICOS DMRT3 SFTPA2 PIGA MGMT MBTPS2 CLCNKB HOXD13 PIK3CA PIK3R1 ACAN FDPS HPGD JAG1 RNASEH2C RECQL4 SCN4A HACE1 RAD54B NR0B1 MITF AHCY GPC4 SCN9A SCN10A HRAS MLF1 MLH1 CTHRC1 TJP2 GTF2H5 FGF3 CC2D2A ANTXR1 LMOD1 PLAG1 FGF8 COL14A1 AKT1 NOP10 ASPSCR1 FGFR1 PLCB4 FGFR3 PLCD1 FGFR2 HAX1 MMP1 MAD2L2 UROD FH MN1 ALK HSPA9 SEC23B SEC23A CARD14 SDHA RAD54L SDHB SDHC SDHD FOXI1 COL1A1 FOXC2 COL2A1 FOXE1 MPL VEGFC ALX3 PMS1 FOXO1 VHL COL4A5 FLI1 MRE11 HSPG2 FLNA KLF11 COL7A1 PIGL SEMA3C BIN1 FLT3 PMS2 FLT4 COL11A2 CIB1 CCDC22 WAS COMP FN1 WIPF1 OFD1 KLF6 ADAMTS3 RNASEH2A LIN28B SFTPC CTC1 PUF60 WHCR NSD2 PPM1D NELFA MAP3K8 INPP5E POLD1 POLE WNT5A POLH GNPTAB SH3GL1 POT1 SH3KBP1 FERMT1 POLR1C WRN TUBB KCNAB2 WT1 APC IKBKG SHH PORCN SHOX BIRC3 POU2AF1 XIAP NLRP1 SAMHD1 XPA MSH2 CHD7 XPC MSH3 ZSWIM6 IDH1 MINPP1 IDH2 TMEM107 TXNRD2 XRCC2 XRCC4 SIX1 SIX3 FANCM SKI FAS FCN3 NHP2 FASLG CR2 CTSA TMEM127 CREB1 CREBBP AR ZAP70 ABCC6 CRKL ZIC2 FAN1 MSR1 MST1 PPP2R1B SETD2 C2CD3 MLH3 PIEZO2 IGF2 ARSA IGF2R MTAP MMEL1 STS GNA14 PMVK SLC12A3 COX1 COX2 UBE2T COX3 IGH SLC17A9 DYNC2LI1 PRCC ELMO2 ASCL1 PRF1 TP63 SLCO2A1 IGHM MTM1 ND1 SETBP1 ND4 ND5 ND6 SNAI2 PTCH2 RNR1 MPLKIP PRKAR1A SMARCB1 ABCB11 WNT10A FLCN SMARCD2 APPL1 PRKCD FOXP1 TRNF C11ORF95 CTBP1 SMO NR5A1 TRNH CTLA4 TRNK IGLL1 TRNL1 ATM RERE MAPK1 CTNNB1 TRNP TRNQ TRNS1 TRNS2 TRNW KDSR SUFU MAP2K1 MAP2K2 CEP57 FZD2 PRDM16 IL2RG G6PC SLC37A4 STAG3 PALLD TRIM37 SLX4 PRLR MUTYH H19 MVD IL7 MVK IL7R SOS1 MYC SOX2 GABRD CYLD MYCN TET2 SOX9 MYD88 IL12A IL12RB1 MYF6 TCTN3 ATP6V1B2 INTU MYH8 MYH11 SAMD9 ATP7A DIS3L2 ATP7B PSAP WWOX MYLK HDAC4 ATR SPIB ACD ATRX SPINK1 ING1 TNFSF12 RTEL1 INHBA PSENEN INS GJB4 CYP11B1 CYP11B2 GJB6 ARHGAP26 KIF1B MAFA RNF113A SRC GAS1 GATA1 CPLX1 GATA2 GATA4 PDX1 BARD1 GBA CDH23 SRP54 FGFRL1 IRF1 NBN SRP72 IRF5 DAXX SRY GCGR CCND1 BCL2 SMARCAD1 GCK NDP KEAP1 TNFRSF10B BCL6 RB1CC1 DCC GPR101 PTCH1 PTEN GDF2 SSX1 BCR SSX2 ADA2 NSUN2 NEK9 DDB2 GDNF DPM1 GINS1 RNF43 GFI1 PTH1R STAR BDNF NAGS STAT1 ITK STAT3 KIAA0753 NOD2 BLK BLM NUTM1 JAK2 STK4 IFIH1 GJA1 STK11 MALT1 NEK1 PTPN3 FAM20C BMPR1A BMPR1B GJB2 GJB3 CCM2 PTPN11 ARL6IP6 KARS NEUROD1 NF1 ANTXR2 DHH GPC3 BRCA1 BRAF BRCA2 NF2 TINF2 SDHAF2 WASHC5 KCNH1 CXCR4 SQSTM1 GLI1 GLI2 GLI3 ABCC8 NBEAL2 DHCR7 DHCR24 KCNJ10 NFKB1 BTK KCNJ11 NFKB2 BUB1 CYP26C1 BUB1B VAMP7 TMC8 MFN2 DKC1 KCNQ1 C1S GNA11 KDR TRPV3 BCL10 DLEC1 GNAI3 GNAQ CDC73 BMPER GNAS SEMA4A GNB1 NME1 TMEM231 FOXH1 PHOX2B CPLANE1 MAPRE2 NODAL TAL1 KIT TAL2 KCNQ1OT1 TNFSF15 DNASE1L3 NOTCH1 NOTCH3 KIF11 CDON DNM2 DNMT3A PNP RAD21 TBX2 RAD51 RAD51C RNASEH2B RAD51D KRAS NPM1 RAF1 KRT1 RAG1 RAG2 CACNA1S KRT5 TCF4 KRT6B EFL1 HNF1A FAT4 HNF1B KRT9 TCF3 CYSLTR2 KRT10 KRT14 EVC2 KCNE3 RARA RPGRIP1L KRT16 CARMIL2 NRAS SRD5A3 KRT17 SASH1 RASA1 RHBDF2 SH2B3 USB1 RB1 TCOF1 NRTN DOCK8 DYNC2H1 CALR GPR35 SLC26A2 NTHL1 NTRK1 MYO1H NUMA1 DVL1 ASCC1 DVL3 NSD1 LAMA3 AGGF1 GPR143 CASP8 B3GALT6 LAMB3 CASP10 GJC2 NR4A3 CASR LAMC2 FANCL RELA OCA2 TDGF1 NUP214 OCRL AIP REST RET MLLT10 RUNX1 WRAP53 CBFB ECE1 GPC6 DLL1 TEK CBL TERC ECM1 AAGAB TERT OGG1 TFAP2A DICER1 WDPCP PALB2 EDN1 LETM1 OPCML MSTO1 EDN3 EDNRB TFE3 ZFPM2 RFWD3 KRIT1 KIF7 SIX6 TG RAD50 ESCO2 VANGL2 RMRP TBX18 TGFBR2 POLR1D SLC22A18 TGIF1 MSH6 COL18A1 USP8 RASGRP1 LIG4 SEMA3D GTF2E2 KLLN RNASEL THPO SF3B1 HMGA2 ALX1 LMNA RNF6 CD19 MS4A1 MTMR14 EGFR LMO1 DCLRE1C ABCA5 LZTS1 LMX1B CD27 TRIM28 CD28 VANGL1 CCBE1 SBDS FANCI BRD4 SLC25A13 MRAP ARMC5 LPP SLC49A4 CHEK2 TREM2 TNFRSF13C FIBP LRRC8A ELANE TNFRSF13B LRP5 CD70 SPRED1 CD79A CD79B CD81 SLC45A2 PRKN PARN HABP2 TAF15 PAX3 EIF2AK4 PAX4 RPL35 PAX6 GREM1 PAX7 SPRTN TNFRSF1B BUB3 KAT6B HBB PDCD10 RNF139 SH2D1A ENG CDH1 EPCAM RSPO1 NNT RPL5 TNPO3 CD96 EP300 DISP1 TOP2A TP53 RPL10 RPL11 SMAD4 RPL15 CDK4 RPL18
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
Neoplasm of the respiratory system
Genes 47
WT1 MLH1 KRAS SLC22A18 STK11 IRF1 MSH6 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA MSH2 KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA RSPO1 TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN