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Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With Squamous Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT03717155
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief Summary:
The main purpose of the study is to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with treatment-naïve advanced squamous NSCLC.

Condition or disease Intervention/treatment Phase
Squamous Non-Small Cell Lung Cancer Drug: Avelumab Drug: Cetuximab Drug: Gemcitabine Drug: Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIa, Single-arm, Multicenter Study to Investigate the Clinical Activity and Safety of Avelumab in Combination With Cetuximab Plus Gemcitabine and Cisplatin in Participants With Advanced Squamous Non-small-cell Lung Cancer
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : January 25, 2021
Estimated Study Completion Date : February 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Avelumab + Cetuximab + Gemcitabine + Cisplatin Drug: Avelumab
Participants will receive avelumab intravenous infusions at a dose of 800 milligram (mg) on Day 1 and Day 8 of each 3-week cycle for the first 4 cycles. Thereafter, it will be given every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities.

Drug: Cetuximab
Participants will receive cetuximab intravenous infusions at a dose of 250 milligram per meter square (mg/m^2) body surface area on Day 1 and 500 mg/m^2 body surface area on Day 8 of first 4 cycles of concurrent chemotherapy. Thereafter, it will be given at a dose of 500 mg/m^2 intravenous every 2 weeks in the Maintenance phase, until disease progression or unacceptable toxicities.

Drug: Gemcitabine
Participants will receive gemcitabine intravenous infusions at a dose of 1250 mg/m^2 body surface area on Day 1 and Day 8 in 3-week cycles up to a maximum of 4 cycles.

Drug: Cisplatin
Participants will receive cisplatin intravenous infusions at a dose of 75 mg/m^2 body surface area on Day 1 of 3-week cycles up to a maximum of 4 cycles.




Primary Outcome Measures :
  1. Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) Assessed by Investigator [ Time Frame: From the first dose of study intervention until planned final assessment at Month 17 ]

Secondary Outcome Measures :
  1. Occurrence of Treatment-emergent Adverse Events (TEAEs), Treatment-related AEs, Treatment-related Grade >= 3 AEs, and Immune-related AEs According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: From the first dose of study intervention until planned final assessment at Month 17 ]
  2. Progression-free Survival (PFS) Time According to RECIST v 1.1 Assessed by Investigator [ Time Frame: From the first dose of study intervention until planned final assessment at Month 17 ]
  3. Duration of response (DOR) as Assessed by Investigator [ Time Frame: From the first dose of study intervention until planned final assessment at Month 17 ]
  4. Peak Serum Concentration of Avelumab and Cetuximab [ Time Frame: Pre-dose up to Week 49/progressive disease (PD), end of treatment (within 7 days of treatment discontinuation), safety follow up (30 days +/- 5 days after last treatment), assessed approximately up to a maximum of Week 104 ]
  5. Trough Serum Concentration of Avelumab and Cetuximab [ Time Frame: Pre-dose up to Week 49/progressive disease (PD), end of treatment (within 7 days of treatment discontinuation), safety follow up (30 days +/- 5 days after last treatment), assessed approximately up to a maximum of Week 104 ]
  6. Number of Participants With Positive Antidrug Antibody (ADA) Assay of Avelumab and Cetuximab in Combination Therapy [ Time Frame: From the first dose of study intervention until planned final assessment at Month 17 ]
  7. Overall Survival [ Time Frame: From the first dose of study intervention until planned final assessment at Month 17 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed Stage IV metastatic or recurrent (Stage IV) NSCLC of squamous histology
  • Availability of formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or a minimum of 15 (preferably 25) unstained tumor slides (cut within 1 week) suitable for Programmed death ligand 1 (PD-L1) expression and epidermal growth factor receptor (EGFR) expression/amplification assessments
  • At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 criteria
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study entry
  • Adequate hematological, hepatic and renal function
  • Estimated life expectancy of at least 3 months
  • Can give signed informed consent
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Participants whose tumor disease harbors an activating EGFR mutation or ALK rearrangement. Participants with tumors of unknown EGFR or ALK status will require testing only in never smokers
  • All participants with brain metastases with protocol defined exceptions
  • Previous malignant disease (other than NSCLC) within the last 5 years (except adequately treated non-melanoma skin cancers, carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least 2 years prior to study entry and the participant was deemed to have been cured with no additional therapy required or anticipated to be required
  • Active infection requiring systemic therapy
  • Known history of human immunodeficiency virus or known acquired immunodeficiency syndrome
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid (RNA) if anti-HCV antibody screening test positive)
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Interstitial parenchymal lung disease
  • Pregnancy or lactation
  • Known alcohol or drug abuse as determined by the Investigator
  • History of uncontrolled intercurrent illness
  • Clinically significant (that is active) cardiovascular disease
  • Known history of inflammatory colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis
  • Any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements
  • Prior/Concomitant Therapy as described in protocol
  • Use of any investigational drug within 28 days before the start of study treatment
  • Other protocol defined exclusion criteria could apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717155


Contacts
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Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
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Hungary
Semmelweis Egyetem - Pulmonologiai Klinika Recruiting
Budapest, Hungary, 1125
Debreceni Egyetem - Tudogyogyaszati Klinika Recruiting
Debrecen, Hungary, 4032
Contact       bittner.nora@med.unideb.hu   
Principal Investigator: Nora Bittner         
Petz Aladar Megyei Oktato Korhaz - Pulmonologiai Osztaly Recruiting
Gyor, Hungary, 9024
Markusovszky Egyetemi Oktatokorhaz Recruiting
Szombathely, Hungary, 9700
Contact    +3694515607    szima.barna@markusovszky.hu   
Principal Investigator: Barna Szima         
Tudogyogyintezet Torokbalint - Onkopulmonologiai es Jarobeteg centrum Recruiting
Torokbalint, Hungary, 2045
Zala Megyei Szent Rafael Korhaz Recruiting
Zalaegerszeg, Hungary, 8900
Contact    +3692501525 ext 2245    tehenes.pul@zmkorhaz.hu   
Principal Investigator: Sandor Tehenes         
Serbia
Clinical Center "Bezanijska kosa" - Department of Oncology Recruiting
Belgrade, Serbia
Contact       drzoranandric@gmail.com   
Principal Investigator: Zoran Andric         
Clinical Center Kragujevac (no dept.) Recruiting
Belgrade, Serbia
Contact       drmarinapetrovic@yahoo.com   
Principal Investigator: Marina Petrovic         
Institute for Pulmonary Diseases of Vojvodina Recruiting
Sremska Kamenica, Serbia
Contact       drgoran0302@yahoo.com   
Principal Investigator: Goran Stojanovic         
Spain
Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia Recruiting
A Coruña, Spain, 15006
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica Recruiting
Barcelona, Spain, 08028
Hospital Universitari Vall d'Hebron - Dept of Oncology Recruiting
Barcelona, Spain, 08035
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica Recruiting
Madrid, Spain, 28007
Contact       antonio.calles@live.com   
Principal Investigator: Antonio Calles Blanco         
Hospital Universitario 12 de Octubre - Servicio de Oncologia Recruiting
Madrid, Spain, 28041
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia Recruiting
Madrid, Spain, 28050
Hospital Regional Universitario de Malaga (11327) Recruiting
Málaga, Spain, 29010
Hospital Universitario Virgen Macarena - Servicio de Oncologia Recruiting
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio Not yet recruiting
Sevilla, Spain
Contact       reyesbernab@yahoo.es   
Principal Investigator: Reyes Bernabe Caro         
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica Recruiting
Valencia, Spain, 46026
Hospital Clinico Universitario Lozano Blesa - Dept of Oncology Recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT03717155     History of Changes
Other Study ID Numbers: MS201944_0170
2018-001529-24 ( EudraCT Number )
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck KGaA, Darmstadt, Germany:
Avelumab
Cetuximab
Cisplatin
Gemcitabine
Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Cetuximab
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological