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Report for Clinical Trial NCT02789345

Developed by Shray Alag, 2020.
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

Necitumumab + Osimertinib Ramucirumab + 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 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
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1