Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC

A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00313768

Enrollment

Registered

2006-04-12

Start date

2005-12-31

Completion date

2008-05-31

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, Phase II, paclitaxel, Taxol, carboplatin, Paraplatin, bevacizumab, Avastin, PF-3512676, immunotherapy, immunomodulator

Brief summary

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer

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/survival follow-up. Data collection was completed on 22 May 2008.

Interventions

DRUGpaclitaxel + carboplatin + bevacizumab

paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles

DRUGcarboplatin + paclitaxel + bevacizumab + PF-3512676

carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles

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 Stage IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung cancer * ECOG Performance Status 0-1 * Measurable disease per RECIST criteria

Exclusion criteria

* Squamous cell, small cell, or carcinoid lung cancer * CNS metastasis * Pre-existing autoimmune or antibody mediated disease * Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or investigation drugs

Design outcomes

Primary

Measure	Time frame
Progression-free survival	110 Events

Secondary

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

Countries

United States

Outcome results

None listed

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