A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Pfizer

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: PF-00299804; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00769067

2008-005235-14 (EudraCT Number)

A7471028

Details and patient eligibility

About

This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

Enrollment: 188 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• advanced measurable Non-Small Cell Lung Cancer (NSCLC);
• progressed after 1-2 prior chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) 0-2;
• tissue available for future KRAS/ EGFR testing

Exclusion criteria

• prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
• active or untreated Central Nervous System (CNS) metastases;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Erlotinib

B

Experimental group

Treatment:

Drug: PF-00299804