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Report for Clinical Trial NCT01466660

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung

This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.

NCT01466660 Lung Neoplasms
MeSH: Adenocarcinoma Lung Neoplasms Adenocarcinoma of Lung
HPO: Neoplasm of the lung

2 Interventions

Name: Afatinib

Description: afatinib once daily

Type: Drug

afatinib

Name: gefitinib

Description: Gefitinib once daily

Type: Drug

gefitinib


Primary Outcomes

Description: Progression-free survival (PFS) defined as the time from the date of randomisation to the date of disease progression, or to date of death if a patient died earlier. Disease progression was primarily evaluated by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.

Measure: Progression-free Survival

Time: From first drug administration until last drug administration, up to 1293 days

Description: Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.

Measure: Time to Treatment Failure (TTF)

Time: From first drug administration until last drug administration, up to 1293 days

Description: Overall survival (OS) which was defined as the time from the date of randomisation to the date of death.

Measure: Overall Survival

Time: From first drug administration until last drug administration, up to 1482 days

Secondary Outcomes

Description: Objective response rate (ORR) which was defined as the number of participants with complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST v1.1. for target lesions and assessed by CT-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Overall Response (OR) = CR + PR

Measure: Objective Response Rate

Time: From first drug administration until last drug administration, up to 1293 days

Description: Number of participants with objective response over time, cumulative number of participants is displayed. Time to objective response was defined as the time from randomisation to the first recorded objective response.

Measure: Time to Objective Response

Time: From first drug administration until last drug administration, up to 1293 days

Description: Duration of objective response defined as the time of first objective response to the time of progression or death, whichever occurred first (or date of censoring for progression free survival (PFS))

Measure: Duration of Objective Response

Time: From first drug administration until last drug administration, up to 1293 days

Description: Disease control which was defined as objective response (complete response or partial response) or stable disease (SD).

Measure: Disease Control

Time: From first drug administration until last drug administration, up to 1293 days

Description: Duration of disease control was measured from randomisation to the time of progressive disease (PD) or death, whichever occurred first (or date of censoring for progression free survival (PFS))

Measure: Duration of Disease Control

Time: From first drug administration until last drug administration, up to 1293 days

Description: Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.

Measure: Tumour Shrinkage

Time: From first drug administration until last drug administration, up to 1293 days

Description: Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS). EQ-5D utility scores range from 0 (worst health) to 1 (full health). EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). Results display the mean score up to 56 weeks.

Measure: Health-related Quality of Life

Time: Every 8 weeks, up to 56 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues. --- L858R ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8