A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (STELLA)

A Randomized, Multicenter, Multinational, Double-Blind Study to Assess the Efficacy and Safety of MB02 (Bevacizumab Biosimilar Drug) Versus Avastin® in Combination With Carboplatin and Paclitaxel for the Treatment of Subjects With Stage IIIB/IV Non-squamous Non-Small Cell Lung Cancer (NSCLC)

This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: MB02 (Bevacizumab Biosimilar Drug); Drug: Carboplatin; Drug: Paclitaxel; Drug: EU-approved Avastin®

Detailed Description

Efficacy parameters, safety profiles and immunogenicity will be compared between MB02 (Bevacizumab Biosimilar Drug) and European (EU)-approved Avastin®

• Study Type: Interventional
• Enrollment (Actual): 627
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Hospital Santa Marcelina
  • AL
    • Maceió, AL, Brazil
      • MedRadius
  • CE
    • Fortaleza, CE, Brazil
      • Instituto do Cancer do Ceara - ICC
  • GO
    • Goiânia, GO, Brazil
      • Centro Brasileiro de Radioterapia Oncologia e Mastologia
  • PR
    • Curitiba, PR, Brazil
      • Hospital Erasto Gaertner - Paranaense de Combate ao Câncer
  • RJ
    • Rio de Janeiro, RJ, Brazil
      • Instituto Nacional de Câncer- INCA
  • RS
    • Caxias do Sul, RS, Brazil
      • Centro de Pesquisa e Educação da Serra Gaúcha (CEPESG)
    • Caxias do Sul, RS, Brazil
      • IPCEM Universidade de Caxias Do Sul
    • Ijuí, RS, Brazil
      • Hospital de Caridade de Ijui
    • Passo Fundo, RS, Brazil
      • Instituto do Câncer - Hospital São Vicente de Paulo
    • Pôrto Alegre, RS, Brazil
      • Hospital Sao Lucas da PUCRS
  • SP
    • Barretos, SP, Brazil
      • Hospital de Cancer de Barretos
    • São José do Rio Prêto, SP, Brazil
      • Hospital de Base de Sao Jose do Rio Preto
    • São Paulo, SP, Brazil
      • Centro de Pesquisa do Instituto Brasileiro de Controle do Câncer - IBCC
    • São Paulo, SP, Brazil
      • Instituto de Ensino E Pesquisa Sao Lucas
• Bulgaria
  • Plovdiv, Bulgaria
    • Central Hospital Plovdiv
  • Sofia, Bulgaria
    • Acıbadem City Clinic Cancer Center UMHAT
  • Sofia, Bulgaria
    • Specialized Hospital for Active Treatment of Oncology Diseases Sofia District EOOD
• Chile
  • Santiago, Chile
    • Fundación Arturo López Pérez - Instituto Oncológico FALP
  • Santiago, Chile
    • Health & Care SPA
  • Temuco, Chile
    • Instituto Clinico Oncologico del Sur ICOS
  • Viña del Mar, Chile
    • Oncocentro APYS
• Georgia
  • Batumi, Georgia
    • Cancer Center of Adjara Autonomous Republic
  • Tbilisi, Georgia
    • Acad. F . Todua medical center-research institute of clinical medicine
  • Tbilisi, Georgia
    • Consilium Medulla
  • Tbilisi, Georgia
    • Institute Of Clinical Oncology
  • Tbilisi, Georgia
    • LTD Aversi Clinic
  • Tbilisi, Georgia
    • LTD Cancer Research Centre
  • Tbilisi, Georgia
    • Tbilisi State Medical Universitys First university Clinic
• Greece
  • Athens, Greece
    • General Hospital of Athens "Ippokratio"
  • Athens, Greece
    • Sotiria General Hospital for Chest Diseases
  • Lárisa, Greece
    • University General Hospital of Larissa
  • Néa Kifisiá, Greece
    • Agioi Anargyroi General Oncological Hospital of Kifissia
  • Thessaloníki, Greece
    • General Hospital of Thessaloniki "George Papanikolaou"
• Hungary
  • Budapest, Hungary
    • National Koranyi Institute of Tb and Pulmonology
  • Budapest, Hungary
    • Országos Korányi Pulmonológiai Intézet (OKPI)
  • Deszk, Hungary
    • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza
  • Farkasgyepű, Hungary
    • Veszprém Megyei Tüdőgyógyinzézet
  • Miskolc, Hungary
    • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
• India
  • Ahmedabad, India
    • Zydus Hospital
  • Delhi, India
    • Action Cancer Hospital
  • Hisar, India
    • Aadhar Health Institute
  • Hyderabad, India
    • NIMS - Nizam's Institute of Medical Sciences
  • Jaipur, India
    • Ganadhipati Purushottam Shekhawati Hospital Research Centre
  • Kerola, India
    • PVS Hospital Pvt Ltd
  • Kolkata, India
    • Apollo Gleneagles Hospital
  • Kolkata, India
    • Netaji Subhas Chandra Bose Cancer Research Institute
  • Nashik, India
    • Shatabdi Super Speciality Hospital
  • Pune, India
    • Deenanath Mangeshkar Hospital & Research Center
  • Surat, India
    • Nirmal Hospital Pvt. Ltd.
  • Sūrat, India
    • Kiran Super Multispeciality Hospital
  • Vadodara, India
    • Shree Himalaya Cancer Hospital Research Institute
  • Visakhapatnam, India
    • Queen's NRI Hospital Gurudwara Lane
• Lebanon
  • Jbaïl, Lebanon
    • Notre Dame De Secours
• Malaysia
  • Kepala Batas, Malaysia
    • Institut Perubatan dan Pergigian Termaju Universiti Sains Malaysia
  • Kuala Lumpur, Malaysia
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia
    • Pusat Perubatan Universiti Kebangsaan Malaysia
  • Kuching, Malaysia
    • Hospital Umum Sarawak
  • Putrajaya, Malaysia
    • National Cancer Institute
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia
      • Hospital Pulau Pinang
• Mexico
  • Mexico City, Mexico
    • Instituto Nacional De Cancerologia
  • Monterrey, Mexico
    • Hospital Universitario Dr. Jose Eleuterio Gonzalez
• Oman
  • Muscat, Oman
    • Sultan Qaboos University Hospital
• Philippines
  • Baguio, Philippines
    • Baguio General Hospital & Medical Center
  • Cebu, Philippines
    • Cebu Doctors University Hospital - CDUH
  • Cebu, Philippines
    • Perpetual Succour Hospital - PSH
  • Dasmariñas, Philippines
    • De La Salle University Medical Center - DLSUMC
  • Davao, Philippines
    • Davao Doctors Hospital - DDH
  • Makati City, Philippines
    • Makati Medical Center
  • Manila, Philippines
    • Philippine General Hospital - PGH
  • Pasig, Philippines
    • The Medical City
  • Taguig, Philippines
    • St. Luke's Medical Center - Global City
• Russian Federation
  • Arkhangel'sk, Russian Federation
    • SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
  • Belgorod, Russian Federation
    • Regional state budgetary Healthcare Institution "Belgorod oncology dispensary"
  • Ivanovo, Russian Federation
    • State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary
  • Kaluga, Russian Federation
    • Kaluga Regional Clinical Oncology Center
  • Kazan', Russian Federation
    • Republic Clinical Oncology Dispensary
  • Kursk, Russian Federation
    • Kursk Republican Clinical Oncology Dispensary
  • Moscow, Russian Federation
    • "VitaMed" LLC
  • Moscow, Russian Federation
    • Moscow City Oncology Hospital № 62
  • Moscow, Russian Federation
    • N. N. Blokhin Russian Cancer Research Center
  • Moscow, Russian Federation
    • University Headache Clinic LLC
  • Novgorod, Russian Federation
    • Federal budget Healthcare Institution "Volga District Medical Centre" under Federal Medical and Biological Agency
  • Pyatigorsk, Russian Federation
    • GBUZ of SK Pyatigorsk Oncology Dispensary
  • Ryazan', Russian Federation
    • Ryazan Regional Clinical Oncology Dispensary
  • Saint Petersburg, Russian Federation
    • City Clinical Oncology Dispensary
  • Saint Petersburg, Russian Federation
    • GUZ "Leningrad Regional Clinical Hospital"
  • Samara, Russian Federation
    • State Budgetary healthcare Institution "Samara regional clinical oncology dispensary"
• Serbia
  • Belgrade, Serbia
    • CHC Bezanijska Kosa
  • Belgrade, Serbia
    • Institute of Oncology and Radiology of Serbia (IORS)
  • Kragujevac, Serbia
    • Clinical Center Kragujevac
  • Niš, Serbia
    • Clinical center Nis (Clinic for pulmonary diseases)
  • Sremska Kamenica, Serbia
    • Institute for pulmonary diseases of Vojvodina
• Spain
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro Majadahonda
• Thailand
  • Bangkok, Thailand
    • Bangkok International Hospital And Wattanosod Hospital
  • Chiang Mai, Thailand
    • Chiang Mai University (CMU) - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital
  • Chiang Rai, Thailand
    • Chiang Rai Prachanukroh Hospital
  • Hat Yai, Thailand
    • Songklanagarind Hospital
  • Phitsanulok, Thailand
    • Buddhachinaraj Hospital
• Turkey
  • İstanbul, Turkey
    • Istanbul Medeniyet University Medical Faculty
  • İzmir, Turkey
    • Suat Seren Chest Diseases Hospital
• Ukraine
  • Cherkasy, Ukraine
    • Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council
  • Chernivtsi, Ukraine
    • Public Higher Education Insititution of Ukraine "Bukovinian State Medical University"
  • Dnepropetrovsk, Ukraine
    • Multifield Clinical Hospital No.4
  • Dnipro, Ukraine
    • Clinical Oncology Dispensary
  • Kharkiv, Ukraine
    • State Institution "Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine"
  • Kharkiv, Ukraine
    • State institution "V.T. Zaycev Institute of general and urgent surgery of National academy medical sciences of Ukraine"
  • Kropyvnytskyi, Ukraine
    • Medical and Diagnostic Centre Private Enterprise of Private Manufacturing Company "ACINUS"
  • Kryvyi Rih, Ukraine
    • Municipal Institution "Kryviy Rih Oncology Dispensary" of Dnipropetrovsk Regional Council
  • Kyiv, Ukraine
    • National Cancer Institute
  • Kyiv, Ukraine
    • National Institute of Cancer
  • L'viv, Ukraine
    • Lviv State Oncology Regional Treatment and Diagnostic Center
  • Luts'k, Ukraine
    • Healthcare facility "Volyn regional Oncological Dispensary"
  • Odessa, Ukraine
    • Odessa Regional Clinical Oncology Dispensary
  • Uzhgorod, Ukraine
    • Uzhgorod National University
  • Vinnytsya, Ukraine
    • Vinnytsia Regional Clinical Oncology Dispensary
  • Zaporizhzhya, Ukraine
    • Communal Institution "Zaporizhzhya Regional Clinical Oncological Dispensary" of Zaporizhzhya regional council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and female subjects aged ≤ 18 years to ≤ 80 years.
2. Signed informed consent must be obtained before initiation of any study-specific procedures or treatment as confirmation of the subject's awareness and willingness to comply with the study requirements.
3. Subjects should have newly diagnosed or recurrent Stage IIIB/IV (defined by seventh edition of the Tumor, Node and Metastasis (TNM) classification for Lung Cancer, 2010) non-squamous NSCLC not amenable to curative intent surgery, and not have received any systemic therapy for advanced disease (exclusion criteria 3 and 4). For subjects with recurrent disease, at least 6 months must have elapsed before randomization from previous adjuvant treatment.
4. Previous radiation therapy if completed >4 weeks before randomization. Palliative radiotherapy to bone lesions is allowed if completed >2 weeks of randomization.
5. Subjects must have at least 1 unidimensional measurable lesion per RECIST version 1.1 (assessed locally).
6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤1 at Screening.

7. Subjects must have adequate hepatic, renal and hematologic function defined as:

   • Hepatic function: bilirubin level <1.5 the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels<2.5×ULN.
   • Renal function: serum creatinine level <1.5×ULN, calculated creatinine clearance (CrCl) >50 mL/min (Cockcroft-Gault formula), urine protein to creatinine ratio <1. Subjects with urine protein-to-creatinine ratio >1 may be enrolled if they have <1 g of protein in 24-hour urine collection.
   • Hematological function: Absolute neutrophil count >1.5×109 /L; platelets >100×109 /L, hemoglobin (Hb) >9 g/dL.
   • Adequate coagulation parameters such as: INR ≤ 2.0 and aPTT ≤ 1.5 x ULN within 7 days prior to randomization for patients not receiving anticoagulation therapy.
8. Eligible subjects must have a systolic blood pressure of ≤ 140 mm Hg and a diastolic blood pressure of ≤90 mm Hg at screening.
9. Women of childbearing potential, and their partners, must agree to adhere to pregnancy prevention methods throughout the duration of the study (including the Follow-up visits, where applicable). Women of childbearing potential are defined as those who are not surgically sterile (did not underwent bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) and not postmenopausal.

Subjects and their partners must agree to use a highly effective method of contraception, to avoid women becoming pregnant throughout the course of the study. Medically acceptable forms of birth control can include the following, with approval of the treating physician:

• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence.

  10. Non fertile women can be included, that is, those who are physiologically incapable of becoming pregnant, because of:

• Hysterectomy.
• Bilateral oophorectomy (ovariectomy).
• Bilateral tubal ligation or,
• Postmenopausal women defined as:

Subjects not using hormone replacement therapy (HRT) and have experienced total cessation of menses for ≥ 1 year and be greater than 45 years of age, OR, in questionable cases, have a follicle stimulating hormone >40 mIU/mL and an estradiol value <40 pg/mL (<140 pmol/L).

Subjects must discontinue HRT before study enrolment because of the potential for inhibition of cytochrome enzymes that metabolize estrogens and progestins. For most forms of HRT, at least 2 to 4 weeks must elapse between the cessation of HRT and determination of menopausal status; the length of this interval depends on the type and dosage of HRT.

If a female subject is determined not to be postmenopausal, that subject must use adequate contraception, as defined immediately above (inclusion 8).

Exclusion Criteria:

1. Inability to comply with protocol procedures.
2. Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives of investigational agent before randomization, whichever is longer.
3. Subjects previously treated with monoclonal antibodies or small molecule inhibitors against Vascular Endothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®.
4. Subjects who have received previous chemotherapy, immunotherapy, targeted therapy, or biological therapy for their lung cancer. Note: Adjuvant and neo- adjuvant therapy are permitted (see: inclusion criterion 3).
5. Subjects who have known central nervous system disease, with the exception of subjects with treated brain metastases who have completed treatment (radiation, surgery or stereotactic surgery) and have not received steroids for at least 4 weeks before randomization. Subjects with central nervous system metastases treated by neurosurgical resection or brain biopsy performed within 8 weeks before randomization will be excluded. Subjects with known or history of brain metastases must undergo brain imaging during screening.
6. Current or recent (within 10 days of the first dose of study treatment) use of aspirin (at least 325 mg/day) or other nonsteroidal anti-inflammatory drugs with antiplatelet activity or treatment with dipyridamole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®), or cilostazol (Pletal®).
7. Current or recent (within 5 days) use of therapeutic anticoagulation or use of thrombolytic agent. Prophylactic use of low molecular weight heparin is allowed.
8. Subjects with an INR >2, unless receiving active anticoagulation treatment, will be excluded.
9. Subjects who have a diagnosis of small cell carcinoma of the lung or squamous cell carcinoma of the lung. Mixed tumors should be categorized according to the predominant histology. If small cell elements are present, the subject will be excluded.
10. Subjects with known tumors that harbor activating epidermal growth factor receptor and anaplastic lymphoma receptor tyrosine kinase (assessed locally).
11. Subjects who have a history of hypersensitivity to the active substance (bevacizumab, carboplatin, and/or paclitaxel) or any of the excipients (such as trehalose dehydrate, sodium phosphate, or polysorbate 20).
12. Subjects with known active viral infection, including but not limited to: hepatitis B, hepatitis C, or HIV.
13. Subjects who are pregnant or breastfeeding. Women of child-bearing potential must have a negative pregnancy test at Screening.
14. Subjects with previous major surgery, open biopsy, open pleurodesis, or significant traumatic injury within 4 weeks before randomization or those anticipated to require major surgery during the study.
15. Subjects who have had a core biopsy taken or have had another minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, and mediastinoscopy, within 1 week of randomization.
16. Subjects with a history of abdominal fistula, GI perforation, intra-abdominal abscess within 6 months of randomization.
17. Subjects with a nonhealing wound, active ulcer, or untreated bone fracture.
18. Subjects with previous history of hypertensive crisis or hypertensive encephalopathy.
19. Subjects with New York Heart Association Grade II or greater congestive heart failure, or angina, myocardial infarction within 6 months before randomization; symptomatic arrhythmia or serious cardiac arrhythmia requiring medication; abnormal left ventricular ejection fraction < 50% assessed by ultrasound or multigated acquisition scan.
20. Subjects with a previous malignancy within 3 years of randomization (other than superficial basal cell and superficial squamous (skin) cell carcinoma, or carcinoma in situ of the uterine cervix, bladder, or prostate).
21. Subjects with history of a significant vascular event within 6 months before randomization (including, but not limited to myocardial infarction and stroke or transient ischemic attack).
22. Subjects with known bleeding diathesis or significant coagulopathy defined as a bleeding event grade ≥ 2 within 3 months before randomization.
23. Subjects with history of grade ≥2 hemoptysis within 6 months before randomization (≥0.5 teaspoons of bright red blood per event).
24. Subjects with a tumor(s) invading or compressing major blood vessels.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MB02 (Bevacizumab Biosimilar Drug); MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel	Drug: MB02 (Bevacizumab Biosimilar Drug); 15 mg/kg IV every 3 weeks on Day 1; Other Names: Bevacizumab; Drug: Carboplatin; Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles; Drug: Paclitaxel; Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles; Other Names: Taxol
Active Comparator: EU-approved Avastin®; EU-approved Avastin® + Carboplatin/Paclitaxel	Drug: Carboplatin; Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles; Drug: Paclitaxel; Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles; Other Names: Taxol; Drug: EU-approved Avastin®; 15 mg/kg IV every 3 weeks on Day 1; Other Names: Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) at Week 18	Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC). Overall Response (OR) = CR + PR.	18 weeks from randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event.	At Week 52 from randomisation
Overall Survival (OS)	Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months.	At Week 52 from randomisation
Incidence of Treatment-emergent Adverse Events (TEAEs)	Comparison of Safety profile. Safety was monitored by incidence of adverse events (AEs). AEs were coded as per MedDRA (version 20.1) and severity was graded according to NCI-CTCAE (version 4.03);	Week 1 to week 52
Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb])	Incidence of anti-drug antibodies (ADA) and neutralizing ADAs (NAb). Analyses of ADA incidence rate, antibody titer, and neutralizing antibodies (NAb) (following the recommended 3-tier approach) were performed.	At Weeks 1, 4, 10, 19, 34 and 52 from randomization and, at the End of Treatment Visit if, an ADA sample has not been collected within the previous 3 weeks

Collaborators and Investigators

• Sponsor: mAbxience Research S.L.

Publications and helpful links

General Publications

• Trukhin D, Poddubskaya E, Andric Z, Makharadze T, Bellala RS, Charoentum C, Yanez Ruiz EP, Fulop A, Hyder Ali IA, Syrigos K, Katgi N, Lopez Chuken YA, Rumyana I, Reyes-Igama J, Costamilan RC, Del Campo Garcia A, Florez A, Paravisini A, Millan S; STELLA Investigators. Efficacy, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar) versus Reference Bevacizumab in Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study (STELLA). BioDrugs. 2021 Jul;35(4):429-444. doi: 10.1007/s40259-021-00483-w. Epub 2021 Apr 29.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): July 3, 2019
• Study Completion (Actual): February 27, 2020

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Bevacizumab
• Other Study ID Numbers: MB02-C-02-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No