Non Small Cell Lung CancerPhase 3SQUIRENCT00981058
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
A Phase 3 study testing Necitumumab, Gemcitabine and Cisplatin in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 182 sites in 26 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Necitumumab, Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,093 participants
- Where
- 182 sitesin 26 countries
- Study dates
- 7 Jan 2010to 30 May 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
182 sites in 26 countries.
182 sites in 26 countries
Germany20 sites
ImClone Investigational Site
Berlin, 12200
ImClone Investigational Site
Essen, 45122
ImClone Investigational Site
Essen, 45136
ImClone Investigational Site
Frankfurt, 60487
ImClone Investigational Site
Gauting, 82131
ImClone Investigational Site
Großhansdorf, 22927
ImClone Investigational Site
Halle, 06120
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Hamburg, 21075
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Hamburg, 22087
ImClone Investigational Site
Heidelberg, 69126
ImClone Investigational Site
Hemer, 58675
ImClone Investigational Site
Hofheim, 65719
ImClone Investigational Site
Karlsruhe, 76137
ImClone Investigational Site
Lostau, 39291
ImClone Investigational Site
Löwenstein, 74245
ImClone Investigational Site
München, 81675
ImClone Investigational Site
Münster, 48149
ImClone Investigational Site
Regensburg, 93042
ImClone Investigational Site
Regensburg, 93049
ImClone Investigational Site
Ulm, 89081
France16 sites
ImClone Investigational Site
Brest, 29609
ImClone Investigational Site
Caen, 14076
ImClone Investigational Site
Draguignan, 83300
ImClone Investigational Site
Grenoble, 38043
ImClone Investigational Site
Le Mans, 72000
ImClone Investigational Site
Le Mans, 72037
ImClone Investigational Site
Lille, 59020
ImClone Investigational Site
Lyon, 69373
ImClone Investigational Site
Marseille, 13009
ImClone Investigational Site
Paris, 75005
ImClone Investigational Site
Paris, 75010
ImClone Investigational Site
Paris, 75571
ImClone Investigational Site
Paris, 75651
ImClone Investigational Site
Rennes, 35033
ImClone Investigational Site
Saint-Jean, 31240
ImClone Investigational Site
Toulon Armées, 83800
United States15 sites
ImClone Investigational Site
Akron, Ohio, 44304
ImClone Investigational Site
Baltimore, Maryland, 21204
ImClone Investigational Site
Camp Hill, Pennsylvania, 17011
ImClone Investigational Site
Chandler, Arizona, 85224
ImClone Investigational Site
Fairfax, Virginia, 22031
ImClone Investigational Site
Fayetteville, Arkansas, 72703
ImClone Investigational Site
Galesburg, Illinois, 61401
ImClone Investigational Site
Goshen, Indiana, 46526
ImClone Investigational Site
Hazard, Kentucky, 41701
ImClone Investigational Site
Jefferson City, Missouri, 65109
ImClone Investigational Site
Lincoln, Nebraska, 68510
ImClone Investigational Site
Memphis, Tennessee, 38104
ImClone Investigational Site
New York, New York, 10065
ImClone Investigational Site
Sacramento, California, 95816
ImClone Investigational Site
Wichita, Kansas, 67214
Russia12 sites
ImClone Investigational Site
Ivanovo, 153013
ImClone Investigational Site
Kirov, 610021
ImClone Investigational Site
Krasnodar, 350040
ImClone Investigational Site
Moscow, 117997
ImClone Investigational Site
Omsk, 644013
ImClone Investigational Site
Saint Petersburg, 194044
ImClone Investigational Site
Saint Petersburg, 194291
ImClone Investigational Site
Saint Petersburg, 197022
ImClone Investigational Site
Saint Petersburg, 198255
ImClone Investigational Site
Smolensk, 214000
ImClone Investigational Site
Ufa, 450054
ImClone Investigational Site
Yaroslavl, 150054
Brazil11 sites
ImClone Investigational Site
Barretos, 14784-400
ImClone Investigational Site
Brasilia, Distrito Federal, 70710-904
ImClone Investigational Site
Goiânia, 74884-606
ImClone Investigational Site
Ijuí, 98700-000
ImClone Investigational Site
Itajaí, 88301-220
ImClone Investigational Site
Lajeado, 95900-000
ImClone Investigational Site
Porto Alegre/RS, 90610-000
ImClone Investigational Site
Salvador, 40050-410
ImClone Investigational Site
Santo André, 09090-780
ImClone Investigational Site
São Paulo, 01224-010
ImClone Investigational Site
São Paulo - SP, 01246-000
Spain11 sites
ImClone Investigational Site
Ávila, Castille and León, 05004
ImClone Investigational Site
Barcelona, Catalonia, 08035
ImClone Investigational Site
Barcelona, Catalonia, 08041
ImClone Investigational Site
Barcelona, 08036
ImClone Investigational Site
L'Hospitalet de Llobregat, 08908
ImClone Investigational Site
Madrid, Communidad de Madrid, 28041
ImClone Investigational Site
Madrid, Communidad de Madrid, 28050
ImClone Investigational Site
Madrid, 28040
ImClone Investigational Site
Majadahonda, Communidad de Madrid, 28222
ImClone Investigational Site
Seville, Andalusia, 41013
ImClone Investigational Site
Terrassa, Catalonia, 08221
United Kingdom10 sites
ImClone Investigational Site
Aberdeen, AB25 2ZN
ImClone Investigational Site
Bournemouth, BH7 7DW
ImClone Investigational Site
Dundee, DD1 9SY
ImClone Investigational Site
Edinburgh, EH4 2XU
ImClone Investigational Site
Guildford, GU2 7XX
ImClone Investigational Site
Liverpool, L14 3PE
ImClone Investigational Site
London, SW10 9NH
ImClone Investigational Site
Manchester, M20 4BX
ImClone Investigational Site
Manchester, M23 9LT
ImClone Investigational Site
Preston, PR2 9HT
Italy9 sites
ImClone Investigational Site
Aviano, Pordenone, 33081
ImClone Investigational Site
Frosinone, 03100
ImClone Investigational Site
Genova, 16132
ImClone Investigational Site
Lido di Camaiore, Lucca, 55041
ImClone Investigational Site
Milan, 20133
ImClone Investigational Site
Milan, 20162
ImClone Investigational Site
Monza, 20900
ImClone Investigational Site
Parma, 43100
ImClone Investigational Site
Perugia, 06126
Hungary8 sites
ImClone Investigational Site
Budapest, 1125
ImClone Investigational Site
Budapest, 1145
ImClone Investigational Site
Deszk, 6772
ImClone Investigational Site
Farkasgyepü, 8582
ImClone Investigational Site
Mosonmagyaróvár, 9200
ImClone Investigational Site
Székesfehérvár, 8000
ImClone Investigational Site
Szombathely, 9700
ImClone Investigational Site
Törökbálint, 2045
Poland8 sites
ImClone Investigational Site
Olsztyn, 10357
ImClone Investigational Site
Otwock, 05-400
ImClone Investigational Site
Poznan, 60-569
ImClone Investigational Site
Radom, 26-617
ImClone Investigational Site
Rzeszów, 35-055
ImClone Investigational Site
Szczecin, 70-891
ImClone Investigational Site
Torun, 87-100
ImClone Investigational Site
Wroclaw, 53-439
Romania8 sites
ImClone Investigational Site
Brasov, 500366
ImClone Investigational Site
Bucharest, 022328
ImClone Investigational Site
Bucharest, 030171
ImClone Investigational Site
Cluj-Napoca, 400015
ImClone Investigational Site
Craiova, Dolj, 200385
ImClone Investigational Site
Iași, 700106
ImClone Investigational Site
Piatra Neamţ, 610136
ImClone Investigational Site
Sibiu, 550245
Philippines7 sites
ImClone Investigational Site
Cebu, 6000
ImClone Investigational Site
Cebu City, 6000
ImClone Investigational Site
Davao City, 8000
ImClone Investigational Site
Makati City, 1229
ImClone Investigational Site
Manila, 1000
ImClone Investigational Site
Quezon City, 1000
ImClone Investigational Site
Quezon City, 1102
South Korea7 sites
ImClone Investigational Site
Incheon, 405760
ImClone Investigational Site
Jeonju, 561712
ImClone Investigational Site
Seongnam, 463-707
ImClone Investigational Site
Seoul, 120752
ImClone Investigational Site
Seoul, 135710
ImClone Investigational Site
Seoul, 138736
ImClone Investigational Site
Suwon, 442723
Australia5 sites
ImClone Investigational Site
East Bentleigh, Victoria, 3165
ImClone Investigational Site
Garran, New South Wales, 2605
ImClone Investigational Site
Geelong, Victoria, 3220
ImClone Investigational Site
Westmead, New South Wales, 2145
ImClone Investigational Site
Wollongong, New South Wales, 2500
Greece4 sites
ImClone Investigational Site
Athens, 11527
ImClone Investigational Site
Heraklion, Crete, 71110
ImClone Investigational Site
Pátrai, 26500
ImClone Investigational Site
Thessaloniki, 57010
Portugal4 sites
ImClone Investigational Site
Coimbra, 3041-801
ImClone Investigational Site
Lisbon, 1099-023
ImClone Investigational Site
Lisbon, 1649-035
ImClone Investigational Site
Porto, 4200-072
Serbia4 sites
ImClone Investigational Site
Belgrade, 11000
ImClone Investigational Site
Kamenitz, 21204
ImClone Investigational Site
Kragujevac, 34000
ImClone Investigational Site
Niš, 18204
Austria3 sites
ImClone Investigational Site
Linz, 4020
ImClone Investigational Site
Vienna, 1090
ImClone Investigational Site
Vienna, 1130
Belgium3 sites
ImClone Investigational Site
Duffel, 2570
ImClone Investigational Site
Liège, 4000
ImClone Investigational Site
Namur, 5000
Canada3 sites
ImClone Investigational Site
Brampton, Ontario, L6R 3J7
ImClone Investigational Site
Saint John, New Brunswick, E2L 4L2
ImClone Investigational Site
Saskatoon, Saskatchewan, S7N 4H4
Croatia3 sites
ImClone Investigational Site
Dubrovnik, 20000
ImClone Investigational Site
Pula, 52100
ImClone Investigational site
Zagreb, 10000
Slovakia3 sites
ImClone Investigational Site
Bratislava, 826 06
ImClone Investigational Site
Nitra, 949 88
ImClone Investigational Site
Poprad, 058 01
South Africa3 sites
ImClone Investigational Site
Bloemfontein, Free State, 9301
ImClone Investigational Site
Durban, KwaZulu-Natal, 4091
ImClone Investigational Site
Pretoria, Gauteng, 0002
Taiwan2 sites
ImClone Investigational Site
Taichung, 40447
ImClone Investigational Site
Taichung, 40705
Thailand2 sites
ImClone Investigational Site
Chiang Mai, 50002
ImClone Investigational Site
Songkhla, 90110
About this study
Official 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)
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.
Read the detailed description
Multinational, randomized, multicenter, open-label, Phase III study of 1093 participants (age ≥ 18 years) with histologically- or cytologically-confirmed, stage IV squamous-cell NSCLC, who have received no prior therapy for metastatic disease, will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study 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 of disease status (computed tomography or magnetic resonance imaging) 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Necitumumab, Gemcitabine, Cisplatin
- Keywords
- Squamous, Non Small Cell Lung Cancer, First line treatment, Monoclonal, Antibodies, Epidermal Growth Factor Receptor (EGFR)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NecitumumabBiological
Also called IMC-11F8, LY3012211
Administered intravenously.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.
GemcitabineDrug
Also called LY2334737
Administered intravenously.
Continues for a maximum of six cycles.
CisplatinDrug
Administered intravenously.
Continues for a maximum of six cycles.
| Study group | Role | What they receive |
|---|---|---|
| Necitumumab + Gemcitabine + Cisplatin | Experimental | 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. Receives: Biological: Necitumumab; Drug: Gemcitabine; Drug: Cisplatin |
| Gemcitabine + Cisplatin | Active comparator | 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. Receives: Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Time (OS)
Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.
Measured: Randomization to Death from Any Cause (Up to 31 Months)
Secondary outcomes (8)
Progression-Free Survival (PFS)
PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.
Measured: Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a >=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
Measured: Baseline to Measured Progressive Disease (Up to 31 Months)
Time to Treatment Failure (TTF)
TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.
Measured: Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
Measured: Baseline, Cycle 6 (Cycle = 3 Weeks)
Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.
Measured: Baseline, Cycle 6 (Cycle = 3 Weeks)
Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of <200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.
Measured: 31 Months
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Measured: Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months
Number of Participants With a Serum Anti-Necitumumab Antibody Assessment
A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.
Measured: Baseline through 31 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study start7 Jan 2010
- Primary completion17 Jun 2013
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel, PPD Development, LP, Medidata Solutions, Laboratory Corporation of America, University of Colorado, Denver, Thermo Fisher Scientific FS, ICON Clinical Research, Pacific Biomarkers, Sysmex Inostics GmbH, Intertek
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981058
- Sponsor's protocol ID
- 13909
- Other IDs
- CP11-0806, I4X-IE-JFCC, 2009-013838-25, 2009
- Acronym
- SQUIRE
- Status last verified
- May 2025
- First submitted
- 18 Sep 2009
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yuan M, Su S, Ding H, Yang Y, Gupta M, Xu XS. Multitask learning of longitudinal circulating biomarkers and clinical outcomes: identification of optimal machine-learning and deep-learning models. BMC Med Inform Decis Mak. 2026 Jun 30. doi: 10.1186/s12911-026-03671-2. Online ahead of print.
PubMed 42381014Ciuleanu 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.
PubMed 29158123Paz-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.
PubMed 27207107Reck 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.
PubMed 26980471Thatcher 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.
PubMed 26045340