A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Eli Lilly and Company
Study ID
NCT02789345
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in combination with osimertinib in participants with non-small cell lung cancer (NSCLC).

Key Dates

Start date
Oct 24, 2016
Status verified
May 2023
Primary completion
Oct 19, 2017
Completion
May 9, 2022

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Ramucirumab + Osimertinib
    Dose Finding: Participants received Ramucirumab 10 milligrams/kilogram (mg/kg) given intravenously (IV) on day 1 every 2 weeks and osimertinib 80 milligrams (mg) given orally daily during each 14-day cycle.
  • Experimental: Arm B: Necitumumab + Osimertinib
    Dose Finding: Participants received Necitumumab 800 mg given IV on days 1 and 8 every 3 weeks and osimertinib 80 mg given orally daily during each 21 day cycle.
  • Experimental: Cohort A: Ramucirumab + Osimertinib
    Dose Expansion: Participants received Ramucirumab 10 mg/kg given IV on day 1 every 2 weeks and osimertinib 80 mg given orally daily during each 14-day cycle.

Primary Outcome Measure

Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Arm A: Cycle 1 through Cycle 2 (14-day cycle); Arm B: Cycle 1 (21-day cycle) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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