Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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Multi-center, open, randomized (parallel) and comparative phase III. Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression. Arm A: Bevacizumab + pemetrexed Arm B: Bevacizumab + pemetrexed + carboplatin

Detailed Description
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Primary: Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival Secondary: To assess the efficacy of bevacizumab as measured by overall response rate and overall survival. To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin. To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13 To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score

Official Title
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Open-label Study of Bevacizumab (Avastin®) in Combination With Pemetrexed or Pemetrexed and Carboplatin as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

Conditions
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Non-squamous Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Bevacizumab + Pemetrexed
* Drug: Bevacizumab + Pemetrexed + Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage IIIb and IV NSCLC, excluded squamous cell NSCLC Age ≥ 65 years ECOG 0-2 Exclusion Criteria: Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component History of haemoptysis Evidence of tumour invading major blood vessels on imaging Radiotherapy within 28 days prior to enrolment Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam) Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, CHF NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication Non-healing wound, active peptic ulcer or bone fracture History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bevacizumab + Pemetrexed<br>Bevacizumab + Pemetrexed | Drug: Bevacizumab + Pemetrexed<br>* Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks<br>* Other names: ALIMTA®;|
| Active Comparator: Bevacizumab + Pemetrexed + Carboplatin<br>Bevacizumab + Pemetrexed + Carboplatin | Drug: Bevacizumab + Pemetrexed + Carboplatin<br>* Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks<br>* Other names: Carboplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study). | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive). | 42 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, NSCLC, elderly, non-squamous, Elderly patients at least 65 years old, first line therapy, non-squamous non-small cell lung cancer stage IIIb or IV