Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Squamous Cell; Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Adenosquamous

Treatments: Drug: CP-751,871 (Figitumumab); Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00596830

A4021016

Details and patient eligibility

About

Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

Full description

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.

Enrollment: 681 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 randomization.
• 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 permitted.
• Patients with other active cancer types are not permitted.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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681 participants in 2 patient groups

A

Experimental group

Description:

Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'

Treatment:

Drug: Paclitaxel

Drug: CP-751,871 (Figitumumab)

Drug: Carboplatin

Drug: Paclitaxel

Drug: Carboplatin

B

Active Comparator group

Description:

Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Paclitaxel

Drug: Carboplatin