Phase 2 N=303 Randomized Treatment

A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.

Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00700180 ↗

Enrolled (actual)

303

Serious AEs

37.4%

Results posted

Sep 2014

Primary outcome: Primary: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level — 42.86; 47.69; 34.85; 49.33 percentage of participants — p=0.8127

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab [Avastin] (Drug); Carboplatin-based chemotherapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level	42.86; 47.69; 34.85; 49.33; 36.99; 42.03	0.8127
SECONDARY Progression-Free Survival - Percentage of Participants With an Event	83.1; 85.9	—
SECONDARY Progression-Free Survival - Time to Event	6.8; 6.7	0.9454
SECONDARY Percentage of Participants With Objective Response	37.1; 46.4	0.1737
SECONDARY Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks	76.8; 78.6	0.6148
SECONDARY Duration of Response - Percentage of Participants With an Event	80.4; 78.5	—
SECONDARY Duration of Response - Time to Event	5.8; 5.6	0.7587
SECONDARY Overall Survival - Percentage of Participants With an Event	64.3; 76.5	—
SECONDARY Overall Survival - Time to Event	13.4; 13.7	0.3120

Summary

This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Eligibility Criteria

Inclusion Criteria

adult patients, >=18 years of age;
locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC);
>=1 measurable tumor lesion;
ECOG performance status 0-1.

Exclusion Criteria

prior chemotherapy or treatment with another systemic anti-cancer agent;
evidence of CNS metastases;
history of grade 2 or higher hemoptysis;
evidence of tumor invading or abutting major blood vessels;
malignancies other than NSCLC within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS;
clinically significant cardiovascular disease;
current or recent use of aspirin (>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00700180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.