Loading clinical trials...

Phase 2 Trial of Durvalumab With or Without Bavituximab in Patients With Previously Treated Metastatic Non-small-cell Lung Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Phase 2 Trial of Durvalumab With or Without Bavituximab in Patients With Previously Treated Metastatic Non-small-cell Lung Cancer

An Open-Label, Randomized, Phase II Trial of Durvalumab (MEDI4736) With or Without Bavituximab in Patients With Previously Treated Metastatic Non-Small Cell Lung Cancer

NCT02673814•Peregrine Pharmaceuticals

View on ClinicalTrials.gov

Summary

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to durvalumab will improve the results of the treatment for non-small-cell lung cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed Written Informed Consent
•Male or female at least 18 years of age
•Histologically or cytologically documented NSCLC (Non-small-cell lung carcinoma) who present with Stage IV disease (according to the American Joint Committee on Cancer Staging Manual \[7th edition\]) or with recurrent disease or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease)
•Disease recurrence or progression during or after one prior platinum-based doublet chemotherapy treatment for advanced or metastatic disease
•Measurable disease on cross-sectional imaging per RECIST 1.1
•Eastern Cooperative Oncology Group performance status 0 or 1
•Tumor tissue (archival or recent tumor biopsy) must be available for biomarker evaluation
•Adequate hematologic function (absolute neutrophil count ≥1500 cells/µL; hemoglobin ≥9 g/dL; platelets ≥100,000/µL).
•Serum creatinine CL\>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
•Adequate hepatic function (serum bilirubin ≤1.5 × ULN, serum albumin levels ≥3.0 g/dL, alanine aminotransferase \[ALT\] ≤2.5 × ULN, and aspartate aminotransferase \[AST\] ≤2.5 × ULN)
+20 more criteria

Exclusion Criteria

•Known history of bleeding diathesis or coagulopathy (von Willebrand disease or hemophilia)
•Tumors invading large blood vessels that, in the opinion of the Investigator, put the patient at risk for major hemorrhage
•Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding, and hemoptysis within the 6 months before screening, unless the cause has been identified and adequately treated (eg, cystitis, ulcer)
•Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months before screening
•Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, arterial embolism, or unstable angina pectoris within 6 months prior to screening
•QT interval using Fridericia's Correction (QTc) \> 500 ms

Key Dates

Start Date

February 1, 2016

Primary Completion Date

April 1, 2017

Completion Date

April 1, 2018

Last Updated

August 1, 2016

Conditions

Non-Small Cell Lung Cancer

Interventions

durvalumab

BIOLOGICAL

bavituximab

BIOLOGICAL

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

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: August 1, 2016Data 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

Phase 2 Trial of Durvalumab With or Without Bavituximab in Patients With Previously Treated Metastatic Non-small-cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)