Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer

A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00321308

Enrollment

Registered

2006-05-03

Start date

2006-09-30

Completion date

2008-01-31

Last updated

2009-09-28

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 cancer, phase II, pemetrexed, Alimta, PF-3512676, immunotherapy, immunomodulator

Brief summary

To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen

Detailed description

PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.

Interventions

DRUGpemetrexed

500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity

DRUGpemetrexed + PF-3512676

pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle 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

* Locally advanced or metastatic NSCLC * Measurable disease * ECOG PS 0 or 1

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	110 Events

Secondary

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

Countries

Germany, Italy, United States

Outcome results

None listed

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