A Study of Bevacizumab Versus Placebo in Combination With Carboplatin/Paclitaxel in Participants With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Double-blinded, Placebo-controlled, Multicenter Phase III Study Comparing Bevacizumab Plus Carboplatin/Paclitaxel Versus Placebo Plus Carboplatin/Paclitaxel in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy For Advanced Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364012
• Other study ID #: YO25404
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2011
• Last updated: February 1, 2018
• Start date: May 23, 2011
• Est. completion date: August 17, 2017

Study information

• Verified date: February 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of bevacizumab (Avastin) versus placebo in combination with carboplatin/paclitaxel in participants with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced disease. Participants will be randomized to receive either bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) or placebo on Day 1 of each 3 week cycle, plus up to 6 cycles of carboplatin/paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. After progression, participants in the bevacizumab arm may continue to receive bevacizumab in combination with approved second- and third-line treatment at the discretion of the investigator, up to the third progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: August 17, 2017
• Est. primary completion date: January 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Locally advanced (Stage IIIb not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Adequate hematological, renal and liver function

Exclusion Criteria:

• Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of the disease (Stage IIIb, IV or recurrent disease)

• Mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component

• Evidence of tumor invading major blood vessels on imaging

• Central nervous system (CNS) metastases, even if previously treated

• History of hemoptysis in the 3 months prior to enrollment

• History or evidence of inherited bleeding diathesis or coagulopathy

• Uncontrolled hypertension and/or history of hypertensive crisis or hypertensive encephalopathy

• Clinically significant cardiovascular or vascular disease

• Malignancies other than non-small cell lung cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or localized prostate cancer or ductal carcinoma in situ treated surgically with curative intent

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Bevacizumab
Bevacizumab will be administered at 15 mg/kg IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
• Carboplatin
Carboplatin will be administered at area under the plasma concentration-time curve (AUC) 6.0 IV on Day 1 of each 3-week cycle, up to 6 cycles.
• Paclitaxel
Paclitaxel will be administered at 175 milligrams per square meter (mg/m^2) IV on Day 1 of each 3-week cycle, up to 6 cycles.
• Placebo
Bevacizumab matching placebo will be administered IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Beijing Chest Hospital; Oncology Department	Beijing
China	Beijing Hospital of Ministry of Health; Hematology	Beijing
China	General Hospital of Chinese PLA; Department of Hematology	Beijing
China	The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha
China	West China Hospital, Sichuan University	Chengdu
China	Guangdong General Hospital	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou
China	Harbin Medical University Cancer Hospital	Harbin
China	Jiangsu Cancer Hospital	Nanjing
China	Guangxi Cancer Hospital of Guangxi Medical University	Nanning
China	Fudan University Shanghai Cancer Center	Shanghai
China	Shanghai chest hospital	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0) Criteria		Baseline up to death or disease progression, whichever occurs first (up to approximately 20 months)
Secondary	Overall Survival (OS)		Baseline up to death (up to approximately 35 months)
Secondary	Percentage of Participants Who are Alive at Year 1		Year 1
Secondary	Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed Using RECIST v1.0 Criteria		Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Secondary	Duration of Response as Assessed Using RECIST v1.0 Criteria		Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Secondary	Percentage of Participants With Adverse Events		From baseline up to approximately 35 months
Secondary	PFS as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by Vascular Endothelial Growth Factor-A (VEGF-A) High/Low Level Expression at Baseline		Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Secondary	PFS as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) High/Low Level Expression at Baseline		Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Secondary	OS in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline		Baseline up to death (up to approximately 35 months)
Secondary	OS in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline		Baseline up to death (up to approximately 35 months)
Secondary	Percentage of Participants With Objective Response of CR or PR as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline		Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Secondary	Percentage of Participants With Objective Response of CR or PR as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline		Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)