Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Bavituximab

• Registration Number: NCT01323062
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).

Detailed Description

Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.

Study Timeline

• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-25
• Study Start: 2011-05
• Primary Completion: 2014-05-14
• Study Completion: 2018-10-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Greater than or equal to 18
• Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy
• Evaluable disease by clinical or radiographic parameters
• No history or concomitant malignancy
• Adequate organ and marrow function
• Female subjects with negative urine or serum pregnancy
• ECOG must be 0 or 1

Exclusion Criteria

• Squamous cell, small cell, or mixed histology
• Known history of bleeding diathesis or coagulopathy
• Cavitary tumors or tumors invading or abutting large blood vessels
• Any history of thromboembolic events
• Ongoing therapy with oral or parenteral anticoagulants
• Major surgery within 4 weeks of Day 1 of treatment
• Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease)
• any history of significant vascular disease
• Congestive heart failure
• History of any condition requiring anti-platelet therapy
• Serious non healing wound
• Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis
• Unable or unwilling to discontinue use of prohibited medications
• D-dimers >2 x ULN as measured on 2 separate occasions at least 1 day apart

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm trial	Bavituximab	Single-arm trial

Primary Outcome Measures

Name	Time	Method
Measure number of severe side effects seen during first cycle of therapy	Three weeks	To determine the maximum tolerated dose based on occurrence of dose-limititing toxicity (DLT) within the first 3 weeks of treatment to determine appropriate and safe dose of bavituximab in combination with carboplatin and pemetrexed

Secondary Outcome Measures

Name	Time	Method
Progression free survival	At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death	to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed

Trial Locations

Locations (2)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Lineberger Comprehensive Cancer Center, UNC; 🇺🇸 Chapel Hill, North Carolina, United States