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

Pfizer

Status and phase

Terminated

Phase 3

Conditions

Carcinoma, Adenosquamous Cell

Carcinoma, Squamous Cell

Carcinoma, Large Cell

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Erlotinib

Drug: CP 751,871 (Figitumumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00673049

A4021018

Details and patient eligibility

About

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).

Full description

This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Enrollment

583 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion criteria

Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
Prior Erlotinib therapy.
Prior anti IGF IR based investigational therapy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

583 participants in 2 patient groups

Arm A

Experimental group

Description:

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.

Treatment:

Drug: CP 751,871 (Figitumumab)

Drug: Erlotinib

Arm B

Active Comparator group

Description:

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)

Treatment:

Drug: Erlotinib