Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00981058




Registration number
NCT00981058
Ethics application status
Date submitted
18/09/2009
Date registered
22/09/2009
Date last updated
20/03/2024

Titles & IDs
Public title
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
Scientific title
A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
CP11-0806
Secondary ID [2] 0 0
13909
Universal Trial Number (UTN)
Trial acronym
SQUIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Necitumumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin

Experimental: Necitumumab + Gemcitabine + Cisplatin -

Active Comparator: Gemcitabine + Cisplatin -


Other interventions: Necitumumab
800 milligrams (mg) Intravenously IV infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.

Treatment: Drugs: Gemcitabine
1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.

Treatment: Drugs: Cisplatin
75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival Time (OS)
Timepoint [1] 0 0
Randomization to Death from Any Cause (Up to 31 Months)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
Secondary outcome [2] 0 0
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])
Timepoint [2] 0 0
Baseline to Measured Progressive Disease (Up to 31 Months)
Secondary outcome [3] 0 0
Time to Treatment Failure (TTF)
Timepoint [3] 0 0
Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)
Secondary outcome [4] 0 0
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)
Timepoint [4] 0 0
Baseline, Cycle 6 (Cycle = 3 Weeks)
Secondary outcome [5] 0 0
Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)
Timepoint [5] 0 0
Baseline, Cycle 6 (Cycle = 3 Weeks)
Secondary outcome [6] 0 0
Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
Timepoint [6] 0 0
31 Months
Secondary outcome [7] 0 0
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Timepoint [7] 0 0
Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months
Secondary outcome [8] 0 0
Number of Participants With a Serum Anti-Necitumumab Antibody Assessment
Timepoint [8] 0 0
Baseline through 31 Months

Eligibility
Key inclusion criteria
- Has histologically or cytologically confirmed squamous NSCLC

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has nonsquamous NSCLC (adenocarcinoma/large cell or other)

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
Accrual to date
Final
1093
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
ImClone Investigational Site - Garran
Recruitment hospital [2] 0 0
ImClone Investigational Site - Westmead
Recruitment hospital [3] 0 0
ImClone Investigational Site - Wollongong
Recruitment hospital [4] 0 0
ImClone Investigational Site - East Bentleigh
Recruitment hospital [5] 0 0
ImClone Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Belgium
State/province [18] 0 0
Duffel
Country [19] 0 0
Belgium
State/province [19] 0 0
Liege
Country [20] 0 0
Belgium
State/province [20] 0 0
Namur
Country [21] 0 0
Brazil
State/province [21] 0 0
Barretos
Country [22] 0 0
Brazil
State/province [22] 0 0
Brasilia, Distrito Federal
Country [23] 0 0
Brazil
State/province [23] 0 0
Goiania
Country [24] 0 0
Brazil
State/province [24] 0 0
Ijui
Country [25] 0 0
Brazil
State/province [25] 0 0
Itajai
Country [26] 0 0
Brazil
State/province [26] 0 0
Lajeado
Country [27] 0 0
Brazil
State/province [27] 0 0
Porto Alegre/RS
Country [28] 0 0
Brazil
State/province [28] 0 0
Salvador
Country [29] 0 0
Brazil
State/province [29] 0 0
Santo Andre
Country [30] 0 0
Brazil
State/province [30] 0 0
Sao Paulo
Country [31] 0 0
Brazil
State/province [31] 0 0
São Paulo - SP
Country [32] 0 0
Canada
State/province [32] 0 0
New Brunswick
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Saskatchewan
Country [35] 0 0
Croatia
State/province [35] 0 0
Dubrovnik
Country [36] 0 0
Croatia
State/province [36] 0 0
Pula
Country [37] 0 0
Croatia
State/province [37] 0 0
Zagreb
Country [38] 0 0
France
State/province [38] 0 0
Brest Cedex
Country [39] 0 0
France
State/province [39] 0 0
Caen
Country [40] 0 0
France
State/province [40] 0 0
Draguignan
Country [41] 0 0
France
State/province [41] 0 0
Grenoble
Country [42] 0 0
France
State/province [42] 0 0
Le Mans Cedex
Country [43] 0 0
France
State/province [43] 0 0
Le Mans
Country [44] 0 0
France
State/province [44] 0 0
Lille
Country [45] 0 0
France
State/province [45] 0 0
Lyon
Country [46] 0 0
France
State/province [46] 0 0
Marseille
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
France
State/province [48] 0 0
Rennes
Country [49] 0 0
France
State/province [49] 0 0
Saint-Jean
Country [50] 0 0
France
State/province [50] 0 0
Toulon Armées
Country [51] 0 0
Germany
State/province [51] 0 0
Berlin
Country [52] 0 0
Germany
State/province [52] 0 0
Essen
Country [53] 0 0
Germany
State/province [53] 0 0
Frankfurt
Country [54] 0 0
Germany
State/province [54] 0 0
Gauting
Country [55] 0 0
Germany
State/province [55] 0 0
Großhansdorf
Country [56] 0 0
Germany
State/province [56] 0 0
Halle
Country [57] 0 0
Germany
State/province [57] 0 0
Hamburg
Country [58] 0 0
Germany
State/province [58] 0 0
Heidelberg
Country [59] 0 0
Germany
State/province [59] 0 0
Hemer
Country [60] 0 0
Germany
State/province [60] 0 0
Hofheim
Country [61] 0 0
Germany
State/province [61] 0 0
Karlsruhe
Country [62] 0 0
Germany
State/province [62] 0 0
Lostau
Country [63] 0 0
Germany
State/province [63] 0 0
Löwenstein
Country [64] 0 0
Germany
State/province [64] 0 0
München
Country [65] 0 0
Germany
State/province [65] 0 0
Münster
Country [66] 0 0
Germany
State/province [66] 0 0
Regensburg
Country [67] 0 0
Germany
State/province [67] 0 0
Ulm
Country [68] 0 0
Greece
State/province [68] 0 0
Athens
Country [69] 0 0
Greece
State/province [69] 0 0
Heraklion, Crete
Country [70] 0 0
Greece
State/province [70] 0 0
Patras
Country [71] 0 0
Greece
State/province [71] 0 0
Thessaloniki
Country [72] 0 0
Hungary
State/province [72] 0 0
Budapest
Country [73] 0 0
Hungary
State/province [73] 0 0
Deszk
Country [74] 0 0
Hungary
State/province [74] 0 0
Farkasgyepü
Country [75] 0 0
Hungary
State/province [75] 0 0
Mosonmagyaróvár
Country [76] 0 0
Hungary
State/province [76] 0 0
Szombathely
Country [77] 0 0
Hungary
State/province [77] 0 0
Székesfehérvár
Country [78] 0 0
Hungary
State/province [78] 0 0
Törökbálint
Country [79] 0 0
Italy
State/province [79] 0 0
Lucca
Country [80] 0 0
Italy
State/province [80] 0 0
Pordenone
Country [81] 0 0
Italy
State/province [81] 0 0
Frosinone
Country [82] 0 0
Italy
State/province [82] 0 0
Genova
Country [83] 0 0
Italy
State/province [83] 0 0
Milano
Country [84] 0 0
Italy
State/province [84] 0 0
Monza
Country [85] 0 0
Italy
State/province [85] 0 0
Parma
Country [86] 0 0
Italy
State/province [86] 0 0
Perugia
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Incheon
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Jeonju-si
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Seongnam
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Seoul
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Suwon
Country [92] 0 0
Philippines
State/province [92] 0 0
Cebu City
Country [93] 0 0
Philippines
State/province [93] 0 0
Cebu
Country [94] 0 0
Philippines
State/province [94] 0 0
Davao City
Country [95] 0 0
Philippines
State/province [95] 0 0
Makati City
Country [96] 0 0
Philippines
State/province [96] 0 0
Manila
Country [97] 0 0
Philippines
State/province [97] 0 0
Quezon City
Country [98] 0 0
Poland
State/province [98] 0 0
Olsztyn
Country [99] 0 0
Poland
State/province [99] 0 0
Otwock
Country [100] 0 0
Poland
State/province [100] 0 0
Poznan
Country [101] 0 0
Poland
State/province [101] 0 0
Radom
Country [102] 0 0
Poland
State/province [102] 0 0
Rzeszow
Country [103] 0 0
Poland
State/province [103] 0 0
Szczecin
Country [104] 0 0
Poland
State/province [104] 0 0
Torun
Country [105] 0 0
Poland
State/province [105] 0 0
Wroclaw
Country [106] 0 0
Portugal
State/province [106] 0 0
Coimbra
Country [107] 0 0
Portugal
State/province [107] 0 0
Lisboa
Country [108] 0 0
Portugal
State/province [108] 0 0
Porto
Country [109] 0 0
Romania
State/province [109] 0 0
Brasov
Country [110] 0 0
Romania
State/province [110] 0 0
Bucharest
Country [111] 0 0
Romania
State/province [111] 0 0
Cluj-Napoca
Country [112] 0 0
Romania
State/province [112] 0 0
Craiova, Dolj
Country [113] 0 0
Romania
State/province [113] 0 0
Iasi
Country [114] 0 0
Romania
State/province [114] 0 0
Piatra Neamt
Country [115] 0 0
Romania
State/province [115] 0 0
Sibiu
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Ivanovo
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Kirov
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Krasnodar
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Moscow
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Omsk
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Smolensk
Country [122] 0 0
Russian Federation
State/province [122] 0 0
St. Petersburg
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Ufa
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Yaroslavl
Country [125] 0 0
Serbia
State/province [125] 0 0
Belgrade
Country [126] 0 0
Serbia
State/province [126] 0 0
Kragujevac
Country [127] 0 0
Serbia
State/province [127] 0 0
Nis
Country [128] 0 0
Serbia
State/province [128] 0 0
Sremska Kamenica
Country [129] 0 0
Singapore
State/province [129] 0 0
Singapore
Country [130] 0 0
Slovakia
State/province [130] 0 0
Bratislava
Country [131] 0 0
Slovakia
State/province [131] 0 0
Nitra
Country [132] 0 0
Slovakia
State/province [132] 0 0
Poprad
Country [133] 0 0
South Africa
State/province [133] 0 0
Free State
Country [134] 0 0
South Africa
State/province [134] 0 0
Gauteng
Country [135] 0 0
South Africa
State/province [135] 0 0
Kwazulu-Natal
Country [136] 0 0
Spain
State/province [136] 0 0
Andalucía
Country [137] 0 0
Spain
State/province [137] 0 0
Castilla Y Leon
Country [138] 0 0
Spain
State/province [138] 0 0
Cataluña
Country [139] 0 0
Spain
State/province [139] 0 0
Communidad De Madrid
Country [140] 0 0
Spain
State/province [140] 0 0
Barcelona
Country [141] 0 0
Spain
State/province [141] 0 0
L'Hospitalet de Llobregat
Country [142] 0 0
Spain
State/province [142] 0 0
Madrid
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taichung
Country [144] 0 0
Thailand
State/province [144] 0 0
Chiang Mai
Country [145] 0 0
Thailand
State/province [145] 0 0
Songkhla
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Aberdeen
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Bournemouth
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Dundee
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Edinburgh
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Guildford
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Liverpool
Country [152] 0 0
United Kingdom
State/province [152] 0 0
London
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Manchester
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
PPD
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Medidata Solutions
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Laboratory Corporation of America
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Colorado, Denver
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Thermo Fisher Scientific FS
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/Industry
Name [7] 0 0
ICON Clinical Research
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Pacific Biomarkers
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Commercial sector/Industry
Name [9] 0 0
Sysmex Inostics GmbH
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Commercial sector/Industry
Name [10] 0 0
Intertek
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The research study is testing the investigational drug necitumumab (IMC-11F8) 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 gemcitabine will be more effective in improving participant disease than the standard
chemotherapy combination alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00981058
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00981058