A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC)

Sponsor
Eli Lilly and Company
Study ID
NCT02411591
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Necitumumab — DRUG
    Administered IV.
  • Abemaciclib — DRUG
    Administered orally.

Study Details

This is medical research evaluating the safety and efficacy of two new medicines (necitumumab and abemaciclib), administered in combination in participants affected by a defined type of advanced lung cancer (stage IV non-small-cell lung cancer).

Key Dates

Start date
Jun 4, 2015
Status verified
Jul 2019
Primary completion
Jun 23, 2017
Completion
May 28, 2019

Study Design

Enrollment
66 participants (actual)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Necitumumab + Abemaciclib
    Cohort 1 Part A: Necitumumab 800 mg administered intravenously (IV) on Days 1 and 8, followed by abemaciclib 100 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met. Cohort 2 Part A: Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. Treatment may continue until discontinuation criterion is met. Cohort 3 Part A: Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 200 mg given orally every 12 hours on Days 1 to 21. Treatment may continue until discontinuation criterion is met. Part B (expansion cohort): Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. Treatment may continue until discontinuation criterion is met.

Primary Outcome Measure

Part A: Number of Participants With Abemaciclib Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (Up to 21 Days) ]

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