SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02504489

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Randomized Blinded Phase III Assessment of Second or Third-Line Chemotherapy With Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced Non-Small Cell Lung Cancer and With at Least One Measurable Lung Lesion

To compare the overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease. Secondary purposes of the study are: - To compare the neutropenia (incidence of Grade 4 neutropenia [absolute neutrophil count (ANC) < 0.5 × 10^9/L]) on Day 8 (+/- 1 day) of Cycle 1), DoR, neutrophil count on Day 8 (+/- 1 day) of Cycle 1, incidence of docetaxel dose reduction and/or docetaxel dose withheld in Cycle 2 due to neutropenia in Cycle 1, QoL (EORTC QLQ-C30 [item 30, average overall quality of life over all observable weeks]), ORR, and PFS in patients with NSCLC treated in the DP Arm to patients treated in the D Arm as 2nd- or 3rd-line therapy for advanced or metastatic disease. - To compare the safety and adverse events profile of the DP Arm to D Arm. - To compare dose intensity of docetaxel (percent dose administered compared to dose assigned) between the 2 treatment arms. - To evaluate population pharmacokinetics in patients enrolled in China and rest of world (RoW).

NCT02504489 Non-Small Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Docetaxel + Plinabulin (DP)

Description: Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2

Type: Drug

Docetaxel + Plinabulin (DP)

Name: Docetaxel (D)

Description: Docetaxel 75 mg/m2 IV

Type: Drug

Docetaxel (D) Docetaxel + Plinabulin (DP)


Primary Outcomes

Description: Overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy

Measure: Overall Survival

Time: Approximately 2 years after study initiation

Secondary Outcomes

Description: Incidence of Grade 4 neutropenia on Day 8 of Cycle 1

Measure: Grade 4 neutropenia

Time: During 1st 21-day cycle

Description: Neutrophil count on Day 8 of Cycle 1

Measure: Neutrophil count

Time: During 1st 21-day cycle

Description: incidence of docetaxel dose reduction and/or docetaxel dose withheld in Cycle 2 due to neutropenia in Cycle 1

Measure: docetaxel dose reduction and/or docetaxel dose withheld

Time: During 2nd 21-day cycle

Description: Average Quality of Life score over all observed weeks (scale 0 - 30, higher value represents better outcome)

Measure: Quality of Life (EORTC QLQ-C30)

Time: Approximately 2 years after study initiation.

Description: Overall response rate

Measure: ORR

Time: Approximately 2 years after study initiation.

Description: Progress-free survival

Measure: PFS

Time: Approximately 2 years after study initiation.

Description: Duration of response

Measure: DoR

Time: Approximately 2 years after study initiation.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Radiographic tumor assessment is to be performed within 28 days prior to randomization. 5. patients with nonsquamous NSCLC must have been tested for EGFR exon 19 deletion and Exon 21 L858R substitution mutation. --- 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