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Report for Clinical Trial NCT02155465

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1/2 Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib

This is a phase 2 study. The goal of this study is to find out what effects, good and/or bad, taking erlotinib and ruxolitinib has on the patients and on lung cancer. Erlotinib and ruxolitinib are FDA approved for other indications, but the use of erlotinib and ruxolitinib together has not been studied before and is not FDA-approved.

NCT02155465 Lung Cancer
MeSH:Adenocarcinoma Adenocarcinoma of Lung

2 Interventions

Name: Ruxolitinib

Description: Ruxolitinib 10mg PO BID Ruxolitinib 15mg PO BID Ruxolitinib 20mg PO BID
Type: Drug
Group Labels: 1

Ruxolitinib and Erlotinib

Name: Erlotinib

Description: Erlotinib 150mg PO QD
Type: Drug
Group Labels: 1

Ruxolitinib and Erlotinib

Primary Outcomes

Measure: Maximally Tolerated Dose (MTD) (Phase I)

Time: 1 year

Description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), at least a 20% increase in the sum of the diameter of the target lesions or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Measure: Assess Overall Response Rate

Time: 1 year

Secondary Outcomes

Description: Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0.

Measure: Number of Participants With NCI CTCAE Toxicity

Time: 2 years

Measure: Progression-free Survival

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There are 2 SNPs


1 L858R

Inclusion Criteria: - Pathologic evidence of advanced (non-operable or metastatic) biopsy-proven stage IV or recurrent lung cancer reviewed at MSKCC. - a documented somatic activating mutation in EGFR (including but not limited to Exon 19 deletion or L858R) - Radiographic progression during treatment with erlotinib. --- L858R ---

2 T790M

- Received erlotinib or other EGFR TK treatment for at least 2 weeks prior to enrollment - Measurable (RECIST 1.1) indicator lesion not previously irradiated - Must have undergone biopsy after development of acquired resistance to erlotinib (which is performed as standard of care) with adequate tissue to determine EGFR T790M and tumor histology. --- T790M ---

HPO Nodes