NCT00828009|CompletedPhase 2ResultsFDA Drug

BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer After Definitive Chemoradiation

ECOG-ACRIN Cancer Research Group ClinicalTrials.gov

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3 other identifiers

CDR0000632611E6508U10CA180794

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2009

StartedJan 2011

CompletionMay 2019

Brief Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine therapy together with bevacizumab after chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine together with bevacizumab after chemotherapy and radiation therapy in treating patients with newly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline

Completed

Started Jan 2011

Longer than P75 for phase_2 lung-cancer

Geographic Reach

1 country

88 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.3 years study duration

First Submitted

Initial submission to the registry

January 22, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed

2 years until next milestone

Study Start

First participant enrolled

January 17, 2011

Completed

7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed

7 months until next milestone

Results Posted

Study results publicly available

March 26, 2019

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2019

Completed

Last Updated

July 7, 2023

Status Verified

June 1, 2023

Enrollment Period

7.6 years

First QC Date

January 22, 2009

Results QC Date

March 3, 2019

Last Update Submit

June 21, 2023

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceradenocarcinoma of the lung

Outcome Measures

Primary Outcomes (1)

Proportion of Patients With Target Adverse Events for the Step 2 Treatment
The study is to evaluate the safety of the combination of tecemotide immunotherapy with bevacizumab. The target adverse events for the combined treatment are as follows: grade 4-5 hemorrhage, esophagitis, fistula, platelet count decrease (thrombocytopenia), encephalitis infection, or hepatic failure episodes.
Assessed every 3 weeks while on treatment and up to 5 years

Secondary Outcomes (2)

Overall Survival
Every 3 months for patients < 2 years from study entry, and every 6 months if patient is 2-5 years from study entry; up to 5 years
Progression-free Survival
Every 3 months for patients < 2 years from study entry, and every 6 months if patient is 2-5 years from study entry; up to 5 years

Study Arms (1)

Tecemotide/bevacizumab after chemoradiation

EXPERIMENTAL

Concomitant Chemoradiotherapy: Patients (pts) receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 15-30 minutes weekly for 6 weeks. Pts also receive radiotherapy 5 days a week for 6½ weeks. Pts with CR, PR, or SD proceed to consolidation chemotherapy. Consolidation chemotherapy: Pts receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression (PD) or unacceptable toxicity. Pts with CR, PR, or SD proceed to maintenance therapy. Maintenance therapy: Pts receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and tecemotide. Pts then receive bevacizumab IV over 30-90 minutes on day 1 and tecemotide subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of PD or unacceptable toxicity.

Biological: bevacizumabBiological: TecemotideDrug: carboplatinDrug: cyclophosphamideDrug: paclitaxelRadiation: radiotherapy