Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

Conditions

• Carcinoma, Adenosquamous Cell
• Carcinoma, Large Cell
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CP 751,871 (Figitumumab) — DRUG
  CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
• Erlotinib — DRUG
  Erlotinib (one tablet of 150 mg/day PO).
• Erlotinib — DRUG
  Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

Study Details

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Key Dates

First listed

May 7, 2008

Start date

May 31, 2008

Status verified

Jul 2013

Primary completion

Mar 31, 2011

Completion

Apr 30, 2012

Study Design

Enrollment

583 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  The CP 751,871 treatment in combination with erlotinib will be given in three week cycles. CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
• Active Comparator: Arm B
  Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)

Primary Outcome Measure

Overall Survival [ Time Frame: Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months ]

Locations (69)

Find similar trials in Fort Smith, AR

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