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LUNG: Metastatic; NSCLC; Phase 1; CDK4/6 inhibitor; "I3Y-MC-JPBJ"

A phase 1b study of LY2835219 in combination with multiple single agent options for patients with stage IV NSCLC

Title

Eli Lilly I3Y-MC-JPBJ

Study Title

A phase 1b study of LY2835219 in combination with multiple single agent options for patients with stage IV NSCLC

Site Link

NCT02079636

Malignancy

Lung cancer; NSCLC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line (Group E only), 3rd or 4th line

Investigational Agent

LY2835219

Drug Class

CDK4/6 inhibitor

Ari VanderWalde, MD

Sponsor

Eli Lilly and Company

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02079636

Key Eligibility Criteria Details

Stage IV NSCLC
ECOG PS 0-1
Off all anti-cancer tx for at least 21 days
No CNS mets
No serious cardiac history (except chronic afib)

Part D (abemaciclib + LY3023414)

At least 3rd line but no more than 4th line
No prior tx with a PI3K or mTOR inhibitor
No history of ILD

Part E (abemaciclib + pembrolizumab)

At least 2nd line but no more than 4th line.

Objective

Primary- Drug-related AEs; Secondary- PK, ORR, PFS, QoL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Non-small cell

Dosing Frequency

abemaciclib orally bid

Control Agents

Study Protocol

Randomized