SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03631706

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.

NCT03631706 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: M7824

Description: Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks starting from Day 1 up to disease progression.

Type: Drug

M7824

Name: Pembrolizumab

Description: Participants will receive an intravenous infusion of 200 mg Pembrolizumab once every 3 weeks starting from Day 1 up to disease progression.

Type: Drug

Pembrolizumab


Primary Outcomes

Measure: Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee

Time: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months

Measure: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee

Time: Time from randomization to planned final assessment, expected at 37 months

Secondary Outcomes

Measure: Occurrences of Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

Time: Randomization up to the last safety follow-up visit, expected at approximately 47 months

Measure: Overall Survival (OS) Time

Time: Randomization up to 49 months

Measure: Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator

Time: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months

Measure: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator

Time: Time from randomization to planned final assessment, expected at 37 months

Measure: Duration of Response Assessed from Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 Assessed by Independent Review Committee

Time: Time from CR or PR to planned assessment, expected at 37 months

Measure: Concentration of M7284 at the end of Infusion (Ceoi)

Time: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months)

Measure: Concentration of M7284 at the end of the Dosing Interval (C trough)

Time: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months)

Measure: Immunogenicity as measured by Anti-drug Antibodies Concentration

Time: Randomization up to safety follow-up visit (28 days post last-dose of study drug administration, assessed up to 47 months)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

- Have measurable disease based on RECIST 1.1 - Have a life expectancy of at least 3 months - Availability of either tumor archival material (less than 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment - PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1 immunohistochemistry 22C3 pharmDx assay - Other protocol defined inclusion criteria could apply Exclusion Criteria: - The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved - Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study - Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations - Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years - Other protocol defined exclusion criteria could apply Inclusion Criteria: - Histologically confirmed diagnosis of advanced NSCLC - Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. --- V600E ---

- Have measurable disease based on RECIST 1.1 - Have a life expectancy of at least 3 months - Availability of either tumor archival material (less than 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment - PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1 immunohistochemistry 22C3 pharmDx assay - Other protocol defined inclusion criteria could apply Exclusion Criteria: - The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved - Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study - Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations - Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years - Other protocol defined exclusion criteria could apply Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- V600E ---



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