Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer (ADVIGO1017)

Pfizer

Status and phase: Withdrawn; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: CP-751,871; Drug: Cisplatin; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00907504

A4021017

Details and patient eligibility

About

Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
• Male or female > 18 years
• Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
• Adequate organ function

Exclusion criteria

• Uncontrolled hypertension or diabetes;
• Pregnant female;
• Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

CP-751,871 + Gemcitabine + Cisplatin

Experimental group

Description:

investigational arm

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: Gemcitabine

Drug: CP-751,871

Drug: Cisplatin

Gemcitabine + Cisplatin

Active Comparator group

Description:

standard of care

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: Gemcitabine

Drug: Cisplatin