Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00321815

Enrollment

Registered

2006-05-04

Start date

2006-08-31

Completion date

2010-06-30

Last updated

2010-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator

Brief summary

To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Interventions

DRUGPF-3512676 + Erlotinib

PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity

DRUGErlotinib

Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Advanced, EGFR-positive NSCLC * ECOG Performance Status 0, 1 or 2 * Measurable disease

Exclusion criteria

* Known CNS metastasis * Pre-existing autoimmune or antibody mediated disease

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival	50Events

Secondary

Measure	Time frame
Overall Safety Profile	28 days post treatment
Time to Tumor Progression	End of treatment
Overall Objective Response Rate	Time of disease progression
Duration of Response	Time of disease progression
Overall Survival	Time of death

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026