SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02411448

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B). The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.

NCT02411448 Metastatic Non-Small Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

5 Interventions

Name: Ramucirumab

Description: Administered IV.

Type: Drug

Ramucirumab + Erlotinib (Part C) Ramucirumab + Gefitinib or Osimertinib

Name: Placebo

Description: Administered IV.

Type: Drug

Placebo + Erlotinib

Name: Erlotinib

Description: Administered orally.

Type: Drug

Ramucirumab + Erlotinib Placebo + Erlotinib

Name: Gefitinib

Description: Administered orally.

Type: Drug

(Part C) Ramucirumab + Gefitinib or Osimertinib

Name: Osimertinib

Description: Administered orally.

Type: Drug

(Part C) Ramucirumab + Gefitinib or Osimertinib


Primary Outcomes

Measure: Progression Free Survival (PFS)

Time: Randomization to Measured Progressive Disease or Death from Any Cause (Estimated as 37 Months)

Measure: Number of Participants with One or More Drug Related Adverse Events (AEs) or Any Serious AEs

Time: Cycle 1 Day 1 through End of Study (Estimated as 38 Months)

Secondary Outcomes

Measure: Overall Survival (OS)

Time: Randomization to Date of Death from Any Cause (Estimated as 47 Months)

Measure: Objective Response Rate (ORR)

Time: Randomization to Disease Progression (Estimated as 37 Months)

Measure: Disease Control Rate (DCR)

Time: Randomization to Disease Progression (Estimated as 37 Months)

Measure: Duration of Response (DoR)

Time: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated as 37 Months)

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

Time: Cycle 2 Predose through Cycle 14 Predose (Estimated as 28 Months)

Measure: Number of Participants with Anti-Ramucirumab Antibodies

Time: Cycle 1 Predose through Follow-up (Estimated as 38 Months)

Measure: Change from Baseline on the Lung Cancer Symptom Scale (LCSS)

Time: Baseline, End of Study (Estimated as 37 Months)

Measure: Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)

Time: Baseline, End of Study (Estimated as 37 Months)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). --- L858R ---

- Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation [exon 19 deletion or exon 21 (L858R) substitution mutation]. --- L858R ---


2 T790M

The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC. --- T790M ---

Exclusion Criteria: - Known T790M EGFR mutation (not applicable for Part C Period 2). --- 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