First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
NCT ID: NCT00981058
Last Updated: 2025-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1093 participants
INTERVENTIONAL
2010-01-07
2024-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Necitumumab + Gemcitabine + Cisplatin
Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
Necitumumab
Administered intravenously.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine
Administered intravenously.
Continues for a maximum of six cycles.
Cisplatin
Administered intravenously.
Continues for a maximum of six cycles.
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles.
Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
Gemcitabine
Administered intravenously.
Continues for a maximum of six cycles.
Cisplatin
Administered intravenously.
Continues for a maximum of six cycles.
Interventions
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Necitumumab
Administered intravenously.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Gemcitabine
Administered intravenously.
Continues for a maximum of six cycles.
Cisplatin
Administered intravenously.
Continues for a maximum of six cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has Stage IV disease at the time of study entry
* Measurable or nonmeasurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (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 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 (failure rate \< 1%) 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 participant is 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 pregnancy test within 7 days prior to randomization
* Has archived tumor tissue available for analysis of EGFR and KRAS mutation status (by PCR) and EGFR gene copy number (by FISH); minimum of four slides, paraffin-embedded tissue, required
Exclusion Criteria
* Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
* Has 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)
* Has undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization
* Has 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
* Has any National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 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
* Has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab (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
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
PPD Development, LP
INDUSTRY
Medidata Solutions
INDUSTRY
Laboratory Corporation of America
INDUSTRY
University of Colorado, Denver
OTHER
Thermo Fisher Scientific FS
OTHER
ICON Clinical Research
INDUSTRY
Pacific Biomarkers
OTHER
Sysmex Inostics GmbH
INDUSTRY
Intertek
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Chandler, Arizona, United States
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Fayetteville, Arkansas, United States
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Sacramento, California, United States
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Galesburg, Illinois, United States
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Goshen, Indiana, United States
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Wichita, Kansas, United States
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Hazard, Kentucky, United States
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Baltimore, Maryland, United States
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Jefferson City, Missouri, United States
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Lincoln, Nebraska, United States
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New York, New York, United States
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Akron, Ohio, United States
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Camp Hill, Pennsylvania, United States
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Memphis, Tennessee, United States
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Fairfax, Virginia, United States
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Garran, New South Wales, Australia
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Westmead, New South Wales, Australia
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Wollongong, New South Wales, Australia
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East Bentleigh, Victoria, Australia
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Geelong, Victoria, Australia
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Duffel, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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Barretos, , Brazil
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Brasilia, Distrito Federal, , Brazil
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Goiânia, , Brazil
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Ijuí, , Brazil
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Itajaí, , Brazil
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Lajeado, , Brazil
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Porto Alegre/RS, , Brazil
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Salvador, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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São Paulo - SP, , Brazil
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Saint John, New Brunswick, Canada
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Brampton, Ontario, Canada
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Saskatoon, Saskatchewan, Canada
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Dubrovnik, , Croatia
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Pula, , Croatia
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Zagreb, , Croatia
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Brest, , France
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Caen, , France
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Draguignan, , France
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Grenoble, , France
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Le Mans, , France
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Le Mans, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Rennes, , France
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Saint-Jean, , France
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Toulon Armées, , France
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Berlin, , Germany
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Essen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Gauting, , Germany
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Großhansdorf, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Hemer, , Germany
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Hofheim, , Germany
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Karlsruhe, , Germany
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Lostau, , Germany
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Löwenstein, , Germany
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München, , Germany
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Münster, , Germany
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Regensburg, , Germany
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Regensburg, , Germany
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Ulm, , Germany
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Athens, , Greece
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Heraklion, Crete, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Deszk, , Hungary
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Farkasgyepü, , Hungary
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Mosonmagyaróvár, , Hungary
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Székesfehérvár, , Hungary
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Szombathely, , Hungary
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Törökbálint, , Hungary
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Lido di Camaiore, Lucca, Italy
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Aviano, Pordenone, Italy
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Frosinone, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Monza, , Italy
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Parma, , Italy
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Perugia, , Italy
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Cebu, , Philippines
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Cebu City, , Philippines
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Davao City, , Philippines
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Makati City, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Olsztyn, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Radom, , Poland
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Rzeszów, , Poland
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Szczecin, , Poland
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Torun, , Poland
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Wroclaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Brasov, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Craiova, Dolj, , Romania
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Iași, , Romania
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Piatra Neamţ, , Romania
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Sibiu, , Romania
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Ivanovo, , Russia
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Kirov, , Russia
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Krasnodar, , Russia
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Moscow, , Russia
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Omsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Ufa, , Russia
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Yaroslavl, , Russia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Singapore, , Singapore
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Bratislava, , Slovakia
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Nitra, , Slovakia
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Poprad, , Slovakia
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Bloemfontein, Free State, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Incheon, , South Korea
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Jeonju, , South Korea
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Seongnam, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Seville, Andalusia, Spain
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Ávila, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Terrassa, Catalonia, Spain
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Madrid, Communidad de Madrid, Spain
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Madrid, Communidad de Madrid, Spain
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Majadahonda, Communidad de Madrid, Spain
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Barcelona, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Chiang Mai, , Thailand
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Songkhla, , Thailand
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Aberdeen, , United Kingdom
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Bournemouth, , United Kingdom
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Dundee, , United Kingdom
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Edinburgh, , United Kingdom
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Guildford, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Manchester, , United Kingdom
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Preston, , United Kingdom
Countries
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References
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Ciuleanu T, Socinski MA, Obasaju C, Luft AV, Szczesna A, Szafranski W, Ramlau R, Balint B, Molinier O, Depenbrock H, Nanda S, Paz-Ares L, Thatcher N. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. Epub 2017 Oct 13.
Paz-Ares L, Socinski MA, Shahidi J, Hozak RR, Soldatenkova V, Kurek R, Varella-Garcia M, Thatcher N, Hirsch FR. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol. 2016 Aug;27(8):1573-9. doi: 10.1093/annonc/mdw214. Epub 2016 May 20.
Reck M, Socinski MA, Luft A, Szczesna A, Dediu M, Ramlau R, Losonczy G, Molinier O, Schumann C, Gralla RJ, Bonomi P, Brown J, Soldatenkova V, Chouaki N, Obasaju C, Peterson P, Thatcher N. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial. J Thorac Oncol. 2016 Jun;11(6):808-18. doi: 10.1016/j.jtho.2016.03.002. Epub 2016 Mar 12.
Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Balint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.
Other Identifiers
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CP11-0806
Identifier Type: OTHER
Identifier Source: secondary_id
I4X-IE-JFCC
Identifier Type: OTHER
Identifier Source: secondary_id
2009-013838-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13909
Identifier Type: -
Identifier Source: org_study_id
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