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Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer

A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

NCT01160601•Peregrine Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults over 18 years of age with a life expectancy of at least 3 months.
•Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
•Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
•Adequate hematologic, renal and hepatic function.
•PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.

Exclusion Criteria

•Squamous cell, small cell, or mixed histology.
•Known history of bleeding diathesis or coagulopathy.
•Cavitary tumors or tumors abutting large blood vessels.
•Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
•Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
•Ongoing therapy with oral or parenteral anticoagulants.
•Concurrent estrogens, anti-estrogens or progesterone compounds.
•Grade 2 or higher peripheral neuropathy.
•Radiotherapy within 2 weeks preceding Study Day 1.
•Symptomatic or clinically active brain metastases.
+3 more criteria

Locations (40)

Ironwood Cancer and Research Center

Chandler, Arizona, United States

Baptist Clinical Research

Jonesboro, Arkansas, United States

American Institute of Research

Whittier, California, United States

Baptist Cancer Institute

Jacksonville, Florida, United States

Community Hospital

Munster, Indiana, United States

Cedar Valley Medical Specialists, PC

Waterloo, Iowa, United States

Southeast Nebraska Cancer Center

Lincoln, Nebraska, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Key Dates

Start Date

June 1, 2010

Primary Completion Date

June 1, 2013

Completion Date

September 1, 2013

Last Updated

April 19, 2017

Enrollment

ACTUAL participants

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

Paclitaxel / Carboplatin

DRUG

bavituximab

DRUG

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

NCT06627647

Non-squamous Non-small Cell Lung Cancer

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RECRUITINGPHASE2/PHASE3

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

NCT06417008

Non-Squamous Non-Small Cell Lung Cancer

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ACTIVE_NOT_RECRUITINGPHASE3

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Paclitaxel-bevacizumab in Advanced Lung Cancer

A Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab in the Treatment of First-line Non-squamous Non-small Cell Lung Cancer(NSCLC).