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Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Carcinoma, Squamous Cell, Carcinoma, Adenosquamous, Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung

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Trial Information

Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

The study was discontinued on December 29, 2009 due to an analysis by an independent Data
Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to
paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving
overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to
terminate the trial was based on futility, not on specific safety concerns; however, the
DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of
the patients.

Inclusion Criteria:

- Confirmed diagnosis of non small cell lung cancer with a primary histology of
predominantly squamous cell, large cell or adenosquamous carcinoma.

- Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or
recurrent disease.

- No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant
chemotherapy must have completed for greater than or equal to 12 months prior to

- Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior
to randomization and all acute toxicities have resolved.

- ECOG performance status (PS) 0 or 1.

Exclusion Criteria:

- Patients with symptomatic central nervous system (CNS) metastases are not permitted.

- Patients requiring chronic steroid use or patients with uncontrolled diabetes are not

- Patients with other active cancer types are not permitted.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

September 2012

Related Keywords:

  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous
  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
  • IGF-1R inhibitor
  • Non-small-cell lung carcinoma
  • CP-751
  • 871
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous
  • Carcinoma, Large Cell



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