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Report for Clinical Trial NCT02504489

Developed by Shray Alag, 2020.
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
Group Labels: 1

Docetaxel + Plinabulin (DP)

Name: Docetaxel (D)

Description: Docetaxel 75 mg/m2 IV
Type: Drug
Group Labels: 2

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: