SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT03620669

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

First Line Durvalumab in Patients With PD-L1 Positive, Advanced NSCLC With Performance Status 2 Unsuitable for Combination Chemotherapy. A Multicenter, Single-arm Phase II Trial

The aim of the trial is to assess efficacy and safety of the treatment with durvalumab in PS 2 patients with treatment-naïve, locally advanced or metastatic, PD-L1 positive NSCLC who are considered unsuitable for combination platinum-containing therapy.

NCT03620669 NSCLC Stage IV NSCLC Stage IIIB
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Durvalumab

Description: Durvalumab 1500mg q4W until progression or unacceptable toxicity
Type: Drug
Group Labels: 1

Durvalumab


Primary Outcomes

Description: OS at 6 months is defined as being alive at 6 months after registration.

Measure: Overall survival (OS) at 6 months

Time: At 6 months after registration

Secondary Outcomes

Description: OR is defined as any complete response (CR) or partial response (PR) according to RECIST 1.1 criteria achieved during trial treatment.

Measure: Objective response (OR) according to RECIST 1.1

Time: At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatment

Description: iOR is defined as any complete response (CR/iCR) or partial response (PR/iPR) according to RECIST1.1 or iRECIST criteria achieved during trial treatment.

Measure: Objective response according to iRECIST (iOR)

Time: At trial treatment discontinuation or the latest 5 years after last patient discontinued trial treatment

Description: DoR is defined as the time from the first documentation of OR until disease progression according to RECIST 1.1 criteria or death due to disease progression, whichever occurs first.

Measure: Duration of response (DoR) according to RECIST 1.1

Time: At disease progression according to RECIST 1.1 criteria or death due to disease progression or the latest 5 years after last patient discontinued trial treatment

Description: iDoR is defined as the time from the first documentation of iOR until disease progression according to iRECIST criteria (iPD) or death due to disease progression.

Measure: Duration of response according to iRECIST (iDoR)

Time: At disease progression according to iRECIST criteria (iPD) or death due to disease progression or the latest 5 years after last patient discontinued trial treatment

Description: PFS is defined as the time from registration until disease progression according to RECIST v1.1 criteria or death due to any cause, whichever occurs first.

Measure: Progression-free survival (PFS) according to RECIST 1.1

Time: At disease progression according to RECIST v1.1 criteria or death due to any cause or the latest 5 years after last patient discontinued trial treatment

Description: iPFS is defined as the time from registration until disease progression according to iRECIST criteria (iPD) or death due to any reason, whichever occurs first. iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial treatment discontinuation. Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment showing no evidence of iPD before starting a subsequent anticancer treatment, if any.

Measure: Progression-free survival according to iRECIST (iPFS)

Time: At disease progression according to iRECIST criteria (iPD) or death due to any reason or the latest 5 years after last patient discontinued trial treatment

Description: OS is defined as the time from registration until death due to any cause

Measure: Overall survival (OS)

Time: At death of the patient or the latest 5 years after last patient discontinued trial treatment

Description: All AEs will be assessed according to NCI CTCAE v5.0

Measure: Adverse events (AEs)

Time: From registration until 28 days after last trial treatment dose

Description: QoL is measured by the Questionnaire Core 30 (QLQ-C30) including the complementary Lung Cancer Module (QLQ-LC13)

Measure: Quality of life (QoL): Core 30 (QLQ-C30)

Time: From registration until trial treatment discontinuation or the latest 1 year after registration

Description: Screening instrument (G8)

Measure: Geriatric assessment (GA) - Screening instrument (G8)

Time: At baseline

Description: Assessment with IADL

Measure: Geriatric assessment (GA) - Assessment with IADL

Time: At baseline

Description: Comorbidities assessment with CCI

Measure: Geriatric assessment (GA)

Time: At baseline

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

Cytology could be accepted if histology is not possible - PD-L1 expression of ≥ 25% of the tumor cells by local testing (Ventana SP142 excluded) - No sensitizing EGFR mutation (L858R or exon 19 deletions), ALK fusion oncogene or rearrangements of the ROS1 gene detected in patients with a non-squamous cell NSCLC - Patient unsuitable for platinum-containing combination chemotherapy according to investigator or due to patient preference - WHO PS of 2. Confirmation of PS2 by a second medical doctor is mandatory. --- L858R ---



HPO Nodes


HPO: