Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Pemetrexed

Bavituximab

Antineoplastic Agents, Immunological

Juneko Grilley Olson, MD

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).

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.

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

A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer

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

to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed

Peregrine Pharmaceuticals

UNC Lineberger Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects	NCT01323062	Non Small Cell ...	Bavituximab	18 Years -	UNC Lineberger Comprehensive Cancer Center
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects	NCT01323062	Non Small Cell ...	Bavituximab	18 Years -	UNC Lineberger Comprehensive Cancer Center

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