A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC

Conditions

• Carcinoma, Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Necitumumab — DRUG
  Administered IV
• Nab-Paclitaxel — DRUG
  Administered IV
• Carboplatin — DRUG
  Administered IV

Study Details

The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus necitumumab is effective and safe in participants with stage IV squamous non-small cell lung cancer.

Key Dates

Start date

Oct 12, 2015

Status verified

Nov 2019

Primary completion

Jan 29, 2018

Completion

Nov 6, 2019

Study Design

Enrollment

54 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Necitumumab + Nab-Paclitaxel + Carboplatin
  Induction: Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 milligram per square meter (mg/m²) on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC (area under curve) 6 milligram per milliliter over time (mg\*min/mL) on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.

Primary Outcome Measure

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR]) [ Time Frame: From Date of Randomization to Objective Disease Progression (Up to 18 Months) ]

Locations (1)

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