Lung Cancer Clinical Trial
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
Summary
The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.
Full Description
Multinational, randomized, multicenter, open-label Phase 3 study of 633 participants with advanced, nonsquamous (Stage IV) NSCLC. Participants will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of pemetrexed and cisplatin in study Arm A, or first-line pemetrexed-cisplatin chemotherapy alone in Arm B.
Baseline radiographic assessment of disease will be performed within 21 days prior to randomization (first treatment will be administered within 7 days following randomization).
Participants will undergo radiographic assessment (computed tomography or magnetic resonance imaging) of disease status every 6 weeks (± 3 days), until there is radiographic documentation of progressive disease (PD). Chemotherapy will continue for a maximum of six cycles in each arm (Or until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or withdrawal of consent); participants in Arm A only will continue to receive necitumumab until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
After the end-of-study-visit (following PD), follow-up information regarding further anticancer treatment and survival will be collected every 2 months (± 7 days). For participants who discontinue study for reasons other than PD (eg, symptomatic deterioration), information on disease progression will also be collected until PD is documented. Follow-up will continue as long as the participant is alive, or until the end of the trial.
Eligibility Criteria
Inclusion Criteria:
Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer
Has Stage IV disease at the time of study entry
Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (participants with only truly nonmeasurable disease are not eligible)
Has resolution to Grade ≤ 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)
Has an Eastern Cooperative Oncology Group performance status score of 0-2
Has adequate hepatic function
Has adequate renal function
Has adequate hematologic function
If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method). If male, the participants surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period
Female participants of childbearing potential must have a negative serum
Exclusion Criteria:
Has squamous non small cell lung cancer
Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the Epidermal Growth Factor Hormone (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor
Received previous chemotherapy for advanced NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization)
Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization
Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible
Has superior vena cava syndrome contraindicating hydration
Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
Has experienced myocardial infarction within 6 months prior to randomization
Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus
Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance
Has Grade ≥ 2 peripheral neuropathy
Has significant third space fluid retention, requiring repeated drainage
Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the participant's ability to complete the study or sign an informed consent document The participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments
Is pregnant or breastfeeding
Has a known history of drug abuse
Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years
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There are 101 Locations for this study
Nyack New York, 10960, United States
Kogarah New South Wales, 2217, Australia
Hobart Tasmania, 7000, Australia
East Bentleigh Victoria, 3165, Australia
Rankweil , 6830, Austria
Wien , 1090, Austria
Wien , 1130, Austria
Duffel , 2570, Belgium
Liège , 4000, Belgium
Namur , 5000, Belgium
Barretos - SP , 14784, Brazil
Brasilia, Distrito Federal , 70310, Brazil
Goiania - GO , 74884, Brazil
Ijui , 98700, Brazil
Itajai , 88301, Brazil
Lajeado , 95900, Brazil
Porto Alegre/RS , 90610, Brazil
Ribeirão Preto - SP , 14015, Brazil
Salvador , 40050, Brazil
Santo Andre - SP , 09090, Brazil
São Paulo - SP , 01246, Brazil
Montreal Quebec, H3T 1, Canada
Pula , 52100, Croatia
Caen , 14076, France
Paris , 75571, France
Berlin , 12200, Germany
Essen , 45136, Germany
Frankfurt , 60487, Germany
Gauting , 82131, Germany
Großhansdorf , 22927, Germany
Halle , 06120, Germany
Hamburg , 21075, Germany
Heidelberg , 69126, Germany
Hemer , 58675, Germany
Hofheim , 65719, Germany
Karlsruhe , 76137, Germany
Lostau , 39291, Germany
Löwenstein , 74245, Germany
Mainz , 55131, Germany
München , 81675, Germany
Münster , 48149, Germany
Regensburg , 93053, Germany
Ulm , 89081, Germany
Athens , 11527, Greece
Heraklion, Crete , 71110, Greece
Patras , 26500, Greece
Budapest , 1125, Hungary
Budapest , 1145, Hungary
Deszk , 6772, Hungary
Mosonmagyaróvár , 9200, Hungary
Szombathely , 9700, Hungary
Székesfehérvár , 8000, Hungary
Törökbálint , 2045, Hungary
Lido di Camaiore Lucca, 55041, Italy
Aviano Pordenone, 33081, Italy
Frosinone , 03100, Italy
Genova , 16132, Italy
Milano , 20133, Italy
Parma , 43100, Italy
Perugia , 06126, Italy
Olsztyn , 10-35, Poland
Otwock , 05-40, Poland
Poznan , 60-56, Poland
Radom , 26-61, Poland
Szczecin , 70-89, Poland
Wroclaw , 53-43, Poland
Coimbra , 3041-, Portugal
Lisboa , 1649-, Portugal
Brasov , 50036, Romania
Bucharest , 02232, Romania
Bucharest , 03017, Romania
Cluj-Napoca , 40001, Romania
Craiova, Dolj , 20038, Romania
Iasi , 70010, Romania
Sibiu , 55024, Romania
Ivanovo , 15301, Russian Federation
Kirov , 61002, Russian Federation
Omsk , 64401, Russian Federation
St. Petersburg , 19404, Russian Federation
St. Petersburg , 19702, Russian Federation
St. Petersburg , 19825, Russian Federation
Ufa , 45005, Russian Federation
Yaroslavi , 15005, Russian Federation
Bratislava , 826 0, Slovakia
Nitra , 949 8, Slovakia
Bloemfontein Free State, 9301, South Africa
Pretoria Gauteng, 0001, South Africa
Sevilla Andalucia, 41013, Spain
Barcelona Cataluña, 08035, Spain
Barcelona Cataluña, 08041, Spain
Terrassa Cataluña, 08221, Spain
Madrid Communidad De Madrid, 28041, Spain
Madrid Communidad De Madrid, 28050, Spain
Majadahonda Communidad De Madrid, 28222, Spain
L'Hospitalet de Llobregat , 08908, Spain
Aberdeen , AB25 , United Kingdom
Bournemouth , BH7 7, United Kingdom
Edinburgh , EH4 2, United Kingdom
Guildford , GU2 7, United Kingdom
Leeds , LS16 , United Kingdom
Preston , PR2 9, United Kingdom
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