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Report for Clinical Trial NCT03122717

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1/2 Study of Osimertinib in Combination With Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

This research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The interventions involved in this study are: - Osimertinib (Tagrisso) - Gefitinib (Iressa)

NCT03122717 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: Gefitinib

Description: gefitinib is a EGFR inhibitor

Type: Drug

Gefitini Gefitinib + Osimertinib

Name: Osimertinib

Description: An orally available, irreversible, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor

Type: Drug

Gefitinib + Osimertinib


Primary Outcomes

Description: The feasibility of combination gefitinib/osimertinib dosing will be determined through evaluation of the number of patients in each cohort who are able to remain on combination therapy for 6 x 28 day cycles.

Measure: Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles

Time: 3 years

Secondary Outcomes

Description: CTCAE v4.0 will be used to monitor toxicities in patients on combination therapy with gefitinib and osimertinib.

Measure: Rate of treatment-related Grade 3-5 adverse events

Time: 3 years

Description: RECIST 1.1 measurements of CT scans of the chest/abdomen/pelvis will be measured every 2 cycles on treatment to determine the objective response rate for patients being treated with combination gefitinib and osimertinib.

Measure: Objective response rate

Time: 3 years (each cycle is 28 days)

Description: The Kaplan-Meier method will be used to determine the progression-free survival of patients enrolled on protocol and treated with combination gefitinib and osimertinib.

Measure: Progression free survival

Time: 3 years

Description: Survival follow-up with clinic visits or phone calls will be used to monitor for overall survival from time of study randomization to death from any cause. The Kaplan-Meier method will be used to calculate overall survival.

Measure: Overall Survival

Time: 3 years

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

The Kaplan-Meier method will be used to calculate overall survival.. Inclusion Criteria: - Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory. --- L858R ---

Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with gefitinib or osimertinib, breastfeeding should be discontinued if the mother is treated with these agents Inclusion Criteria: - Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory. --- L858R ---


2 T790M

Patients must be off warfarin for >7 days prior to enrollment - Identification of EGFR T790M in baseline cfDNA analysis - Active pregnancy or breast-feeding. --- T790M ---

However, even though these drugs can be very effective, after a period of time, most EGFR tumors will develop resistance to this treatment, most often because of a second mutation in EGFR called T790M. --- T790M ---

Osimertinib is currently approved only to treat patients whose cancers develop resistance to gefitinib (or other similar EGFR inhibitors) because of the T790M mutation. --- 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