Randomized Comparative Study of Erlotinib and Pemetrexed in the Maintenance Treatment of Advanced Lung Cancer Patients.

Sponsor
Hikma Pharmaceuticals LLC
Study ID
NCT03460678
Phase
PHASE4
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Pemetrexed — DRUG
    Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium) administered as 500mg/m2 IV over 10 minutes on the first day of each 21-day cycle, until disease progression or unacceptable toxic effects
  • Erlotinib — DRUG
    Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride) administered once daily until disease progression or unacceptable toxic effects

Study Details

The purpose of this multicenter randomized study is to compare the effectiveness and safety of erlotinib and pemetrexed in the maintenance treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC)

Key Dates

First listed
Mar 9, 2018
Start date
Feb 28, 2018
Status verified
Mar 2020
Primary completion
Nov 14, 2018
Completion
Nov 14, 2018

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Pemetrexed Arm
    Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium)
  • Other: Erlotinib Arm
    Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride)

Primary Outcome Measure

Progression-Free Survival (PFS) in eligible patients randomized to erlotinib or pemetrexed treatment arms [ Time Frame: 12 months ]

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