Overview

This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Treatments bevacizumab [avastin], carboplatin, paclitaxel, placebo
Phase phase 3
Target VEGF
Sponsor Hoffmann-La Roche
Start date May 2011
End date December 2016
Trial size 276 participants
Trial identifier NCT01364012, YO25404

Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of Avastin (bevacizumab) versus placebo in combination with carboplatin/paclitaxel in patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced disease. Patients will be randomized to receive either Avastin 15 mg/kg intravenously 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, patients in the Avastin-arm may continue to receive Avastin in combination with approved second- and third-line treatment at the discretion of the investigator, up to the third progression.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
bevacizumab [avastin]
15 mg/kg intravenously (iv) on Day 1 of each 3-week cycle
carboplatin
AUC 6.0 iv on Day 1 of each 3-week cycle, up to 6 cycles
paclitaxel
175 mg/m2 iv on Day 1 of each 3-week cycle, up to 6 cycles
(Active Comparator)
carboplatin
AUC 6.0 iv on Day 1 of each 3-week cycle, up to 6 cycles
paclitaxel
175 mg/m2 iv on Day 1 of each 3-week cycle, up to 6 cycles
placebo
15 mg iv on Day 1 of each 3-week cycle

Primary Outcomes

Measure
Progression-free survival (PFS), tumour assessments according to RECIST criteria
time frame: approximately 24 months

Secondary Outcomes

Measure
Overall survival (OS)
time frame: approximately 48 months
1-year survival rate
time frame: approximately 30 months
Overall response rate (ORR): complete response + partial response
time frame: approximately 24 months
Duration of response
time frame: approximately 24 months
Safety: Incidence of adverse events
time frame: approximately 48 months
Correlation of baseline vascular endothelial growth factor (VEGF) plasma levels with clinical outcome (PFS/OS/ORR)
time frame: approximately 48 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Locally advanced (Stage IIIb not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC) - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Adequate haematological, renal and liver function Exclusion Criteria: - Prior chemotherapy or treatment with another systemic anti-cancer agent for the current stage of the disease (IIIb, IV or recurrent) - Mixed non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component - Evidence of tumour invading major blood vessels on imaging - CNS metastases, even if previously treated - History of haemoptysis 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 NSCLC 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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.