NCT00334815|Active Not RecruitingPhase 2Results

Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-small Cell Lung Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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6 other identifiers

NCI-2009-01097SWOG-S0533CDR0000472907S0533U10CA180888U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2006

StartedJun 2006

CompletionFeb 2027

Brief Summary

This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

10mo left

Started Jun 2006

Longer than P75 for phase_2

Geographic Reach

1 country

62 active sites

Status

active not recruiting

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

20.7 years study duration

Study Progress96%

Jun 2006Feb 2027

First Submitted

Initial submission to the registry

June 7, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed

7 days until next milestone

Study Start

First participant enrolled

June 15, 2006

Completed

8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

February 29, 2016

Completed

11 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2027

Expected

Last Updated

April 29, 2026

Status Verified

February 1, 2026

Enrollment Period

8 years

First QC Date

June 7, 2006

Results QC Date

September 22, 2015

Last Update Submit

April 10, 2026

Conditions

Lung Adenocarcinoma Lung Adenosquamous Carcinoma Lung Large Cell Carcinoma Lung Squamous Cell Carcinoma Minimally Invasive Lung Adenocarcinoma Stage IIIA Lung Non-Small Cell Cancer AJCC v7 Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

Adverse Events
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Up to one year

Secondary Outcomes (3)

Progression-free Survival
Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.
Overall Survival
Every week, up to 4 years
Response Rate (Confirmed or Unconfirmed Partial Response)
Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration

Study Arms (3)

Group 1 (cisplatin, etoposide, radiotherapy)

EXPERIMENTAL

Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.

Drug: CisplatinDrug: DocetaxelDrug: EtoposideBiological: FilgrastimBiological: PegfilgrastimRadiation: Radiation Therapy

Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)

EXPERIMENTAL

Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.

Biological: BevacizumabDrug: CisplatinDrug: DocetaxelDrug: EtoposideBiological: FilgrastimBiological: PegfilgrastimRadiation: Radiation Therapy

Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)

EXPERIMENTAL

Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.

Biological: BevacizumabDrug: CisplatinDrug: DocetaxelDrug: EtoposideBiological: FilgrastimBiological: PegfilgrastimRadiation: Radiation Therapy

Interventions

BevacizumabBIOLOGICAL

Given IV

Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev

Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)

CisplatinDRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin