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Report for Clinical Trial NCT03292133

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer

This research study is studying a combination of drugs as a possible treatment for EGFR mutation-positive lung cancer. The drugs involved in this study are: - EGF816 - Gefitinib

NCT03292133 Lung Cancer
MeSH: Lung Neoplasms
HPO: Neoplasm of the lung

2 Interventions

Name: EGF816

Description: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying

Type: Drug

EGF816 + Gefitinib

Name: Gefitinib

Description: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying

Type: Drug

EGF816 + Gefitinib


Primary Outcomes

Description: The number of participants that are free from objective disease progression or death at 9 months. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Measure: Progression Free Survival at 9 months

Time: 9 months

Secondary Outcomes

Description: The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All CRs and PRs must be confirmed by a second assessment not earlier than 4 weeks after the criteria for response are first met.

Measure: Response Rate

Time: 2 years

Description: Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.

Measure: Overall Survival

Time: 2 years

Description: Summary of the adverse events experienced by study participants as evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v4.

Measure: Safety and Tolerability of the EGF816/gefitinib combination (Summary of the adverse events experienced by study participants as evaluated by CTCAE v4)

Time: 2 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 L858R

Specifically, patients harboring the most common mutations, deletions in exon 19 or the L858R mutation in exon 21 are eligible. --- L858R ---



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