SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02789345

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Open-Label, Multicenter, Phase 1 Study With Expansion Cohorts of Ramucirumab or Necitumumab in Combination With Osimertinib in Patients With Advanced T790M-Positive EGFR-Mutant Non-Small Cell Lung Cancer After Progression on First-Line EGFR TKI Therapy

The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in combination with osimertinib in participants with non-small cell lung cancer (NSCLC).

NCT02789345 Non-small Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Ramucirumab

Description: Administered IV

Type: Drug

Ramucirumab + Osimertinib

Name: Necitumumab

Description: Administered IV

Type: Drug

Necitumumab + Osimertinib

Name: Osimertinib

Description: Administered orally

Type: Drug

Ramucirumab + Osimertinib Necitumumab + Osimertinib

Primary Outcomes

Measure: Number of Participants with Dose Limiting Toxicities (DLTs)

Time: Up to Two Cycles (Up to 21 Day Cycles)

Secondary Outcomes

Measure: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Time: Day 1 Cycle 2 to Day 1 Cycle 13 (14 Day Cycles)

Measure: PK: Cmin of Necitumumab

Time: Day 1 Cycle 3 to Day 1 Cycle 9 (21 Day Cycles)

Measure: Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)

Time: Baseline to Objective Disease Progression (Approximately 30 Months)

Measure: Disease Control Rate (DCR): Percentage of Participants with CR, PR or Stable Disease (SD)

Time: Baseline to Objective Disease Progression (Approximately 30 Months)

Measure: Duration of Response (DoR)

Time: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Approximately 30 Months)

Measure: Progression Free Survival (PFS)

Time: Baseline to Measured Progressive Disease or Death from Any Cause (Approximately 30 Months)

Measure: Overall Survival (OS)

Time: Baseline to Death from Any Cause (Approximately 30 Months)
Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment

There is one SNP

SNPs

1 T790M

An Open-Label, Multicenter, Phase 1 Study With Expansion Cohorts of Ramucirumab or Necitumumab in Combination With Osimertinib in Patients With Advanced T790M-Positive EGFR-Mutant Non-Small Cell Lung Cancer After Progression on First-Line EGFR TKI Therapy. --- T790M ---

- Have T790M-positive status using a test validated and performed locally after disease progression on EGFR tyrosine kinase inhibitor (TKI) treatment. --- T790M ---


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