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First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (SQUIRE)

Primary Purpose

Non Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Necitumumab
Gemcitabine
Cisplatin
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Squamous, Non Small Cell Lung Cancer, First line treatment, Monoclonal, Antibodies, Epidermal Growth Factor Receptor (EGFR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Necitumumab + Gemcitabine + Cisplatin

Gemcitabine + Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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.
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.
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
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.

Full Information

First Posted
September 18, 2009
Last Updated
April 12, 2023
Sponsor
Eli Lilly and Company
Collaborators
Parexel, PPD, Medidata Solutions, Laboratory Corporation of America, University of Colorado, Denver, Thermo Fisher Scientific FS, ICON Clinical Research, Pacific Biomarkers, Sysmex Inostics GmbH, Intertek
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1. Study Identification

Unique Protocol Identification Number
NCT00981058
Brief Title
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
Acronym
SQUIRE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 1, 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 7, 2010 (Actual)
Primary Completion Date
June 17, 2013 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Parexel, PPD, Medidata Solutions, Laboratory Corporation of America, University of Colorado, Denver, Thermo Fisher Scientific FS, ICON Clinical Research, Pacific Biomarkers, Sysmex Inostics GmbH, Intertek

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Squamous, Non Small Cell Lung Cancer, First line treatment, Monoclonal, Antibodies, Epidermal Growth Factor Receptor (EGFR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1093 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Necitumumab + Gemcitabine + Cisplatin
Arm Type
Experimental
Arm Title
Gemcitabine + Cisplatin
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Necitumumab
Other Intervention Name(s)
IMC-11F8, LY3012211
Intervention Description
800 milligrams (mg) Intravenously IV infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
LY2334737
Intervention Description
1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
Primary Outcome Measure Information:
Title
Overall Survival Time (OS)
Description
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.
Time Frame
Randomization to Death from Any Cause (Up to 31 Months)
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
Title
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])
Description
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.
Time Frame
Baseline to Measured Progressive Disease (Up to 31 Months)
Title
Time to Treatment Failure (TTF)
Description
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.
Time Frame
Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)
Title
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)
Description
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).
Time Frame
Baseline, Cycle 6 (Cycle = 3 Weeks)
Title
Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)
Description
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.
Time Frame
Baseline, Cycle 6 (Cycle = 3 Weeks)
Title
Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
Description
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.
Time Frame
31 Months
Title
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Time Frame
Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months
Title
Number of Participants With a Serum Anti-Necitumumab Antibody Assessment
Description
A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.
Time Frame
Baseline through 31 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
ImClone Investigational Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
ImClone Investigational Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
ImClone Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
ImClone Investigational Site
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
ImClone Investigational Site
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
ImClone Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
ImClone Investigational Site
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
ImClone Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
ImClone Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
ImClone Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
ImClone Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
ImClone Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
ImClone Investigational Site
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
ImClone Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
ImClone Investigational Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
ImClone Investigational Site
City
Garran
State/Province
New South Wales
ZIP/Postal Code
2605
Country
Australia
Facility Name
ImClone Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
ImClone Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
ImClone Investigational Site
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
ImClone Investigational Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
ImClone Investigational Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
ImClone Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
ImClone Investigational Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
ImClone Investigational Site
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Facility Name
ImClone Investigational Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
ImClone Investigational Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
ImClone Investigational Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
ImClone Investigational Site
City
Brasilia, Distrito Federal
ZIP/Postal Code
70710-904
Country
Brazil
Facility Name
ImClone Investigational Site
City
Goiania
ZIP/Postal Code
74884-606
Country
Brazil
Facility Name
ImClone Investigational Site
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
Itajai
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
ImClone Investigational Site
City
Lajeado
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
Porto Alegre/RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
ImClone Investigational Site
City
Santo Andre
ZIP/Postal Code
09090-780
Country
Brazil
Facility Name
ImClone Investigational Site
City
Sao Paulo
ZIP/Postal Code
01224-010
Country
Brazil
Facility Name
ImClone Investigational Site
City
São Paulo - SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
ImClone Investigational Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
ImClone Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
ImClone Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
ImClone Investigational Site
City
Dubrovnik
ZIP/Postal Code
20000
Country
Croatia
Facility Name
ImClone Investigational Site
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
ImClone Investigational site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
ImClone Investigational Site
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
ImClone Investigational Site
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
ImClone Investigational Site
City
Draguignan
ZIP/Postal Code
83300
Country
France
Facility Name
ImClone Investigational Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
ImClone Investigational Site
City
Le Mans Cedex
ZIP/Postal Code
72037
Country
France
Facility Name
ImClone Investigational Site
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
ImClone Investigational Site
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
ImClone Investigational Site
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
ImClone Investigational Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
ImClone Investigational Site
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
ImClone Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
ImClone Investigational Site
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
ImClone Investigational Site
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
ImClone Investigational Site
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
ImClone Investigational Site
City
Saint-Jean
ZIP/Postal Code
31240
Country
France
Facility Name
ImClone Investigational Site
City
Toulon Armées
ZIP/Postal Code
83800
Country
France
Facility Name
ImClone Investigational Site
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
ImClone Investigational Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
ImClone Investigational Site
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
ImClone Investigational Site
City
Frankfurt
ZIP/Postal Code
60487
Country
Germany
Facility Name
ImClone Investigational Site
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
ImClone Investigational Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
ImClone Investigational Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
ImClone Investigational Site
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
ImClone Investigational Site
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
ImClone Investigational Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
ImClone Investigational Site
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
ImClone Investigational Site
City
Hofheim
ZIP/Postal Code
65719
Country
Germany
Facility Name
ImClone Investigational Site
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
ImClone Investigational Site
City
Lostau
ZIP/Postal Code
39291
Country
Germany
Facility Name
ImClone Investigational Site
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
ImClone Investigational Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
ImClone Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
ImClone Investigational Site
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
ImClone Investigational Site
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
ImClone Investigational Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
ImClone Investigational Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
ImClone Investigational Site
City
Heraklion, Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
ImClone Investigational Site
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
ImClone Investigational Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
ImClone Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
ImClone Investigational Site
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
ImClone Investigational Site
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
ImClone Investigational Site
City
Farkasgyepü
ZIP/Postal Code
8582
Country
Hungary
Facility Name
ImClone Investigational Site
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
ImClone Investigational Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
ImClone Investigational Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
ImClone Investigational Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
ImClone Investigational Site
City
Lido di Camaiore
State/Province
Lucca
ZIP/Postal Code
55041
Country
Italy
Facility Name
ImClone Investigational Site
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
ImClone Investigational Site
City
Frosinone
ZIP/Postal Code
03100
Country
Italy
Facility Name
ImClone Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
ImClone Investigational Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
ImClone Investigational Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
ImClone Investigational Site
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
ImClone Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
ImClone Investigational Site
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
ImClone Investigational Site
City
Incheon
ZIP/Postal Code
405760
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Jeonju-si
ZIP/Postal Code
561712
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Seoul
ZIP/Postal Code
120752
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Seoul
ZIP/Postal Code
138736
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Suwon
ZIP/Postal Code
442723
Country
Korea, Republic of
Facility Name
ImClone Investigational Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
ImClone Investigational Site
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
ImClone Investigational Site
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
ImClone Investigational Site
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Facility Name
ImClone Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
ImClone Investigational Site
City
Quezon City
ZIP/Postal Code
1000
Country
Philippines
Facility Name
ImClone Investigational Site
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
ImClone Investigational Site
City
Olsztyn
ZIP/Postal Code
10357
Country
Poland
Facility Name
ImClone Investigational Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
ImClone Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
ImClone Investigational Site
City
Radom
ZIP/Postal Code
26-617
Country
Poland
Facility Name
ImClone Investigational Site
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
ImClone Investigational Site
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
ImClone Investigational Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
ImClone Investigational Site
City
Wroclaw
ZIP/Postal Code
53-439
Country
Poland
Facility Name
ImClone Investigational Site
City
Coimbra
ZIP/Postal Code
3041-801
Country
Portugal
Facility Name
ImClone Investigational Site
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
ImClone Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
ImClone Investigational Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
ImClone Investigational Site
City
Brasov
ZIP/Postal Code
500366
Country
Romania
Facility Name
ImClone Investigational Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
ImClone Investigational Site
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
ImClone Investigational Site
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
ImClone Investigational Site
City
Craiova, Dolj
ZIP/Postal Code
200385
Country
Romania
Facility Name
ImClone Investigational Site
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
ImClone Investigational Site
City
Piatra Neamt
ZIP/Postal Code
610136
Country
Romania
Facility Name
ImClone Investigational Site
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
ImClone Investigational Site
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Kirov
ZIP/Postal Code
610021
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Smolensk
ZIP/Postal Code
214000
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
ImClone Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
ImClone Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
ImClone Investigational Site
City
Nis
ZIP/Postal Code
18204
Country
Serbia
Facility Name
ImClone Investigational Site
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
ImClone Investigational Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
ImClone Investigational Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
ImClone Investigational Site
City
Nitra
ZIP/Postal Code
949 88
Country
Slovakia
Facility Name
ImClone Investigational Site
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
ImClone Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
ImClone Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
ImClone Investigational Site
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
ImClone Investigational Site
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
ImClone Investigational Site
City
Avila
State/Province
Castilla Y Leon
ZIP/Postal Code
05004
Country
Spain
Facility Name
ImClone Investigational Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
ImClone Investigational Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Facility Name
ImClone Investigational Site
City
Terrassa
State/Province
Cataluña
ZIP/Postal Code
08221
Country
Spain
Facility Name
ImClone Investigational Site
City
Madrid
State/Province
Communidad De Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
ImClone Investigational Site
City
Madrid
State/Province
Communidad De Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
ImClone Investigational Site
City
Majadahonda
State/Province
Communidad De Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
ImClone Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
ImClone Investigational Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
ImClone Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
ImClone Investigational Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
ImClone Investigational Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
ImClone Investigational Site
City
Chiang Mai
ZIP/Postal Code
50002
Country
Thailand
Facility Name
ImClone Investigational Site
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
ImClone Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
ImClone Investigational Site
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29158123
Citation
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.
Results Reference
derived
PubMed Identifier
27207107
Citation
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.
Results Reference
derived
PubMed Identifier
26980471
Citation
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.
Results Reference
derived
PubMed Identifier
26045340
Citation
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.
Results Reference
derived

Learn more about this trial

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin

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