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

March 19, 2024 updated by: Eli Lilly and Company

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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Interventional

Enrollment (Actual)

1093

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Necitumumab + Gemcitabine + Cisplatin

800 milligrams (mg) Intravenously IV infusion on Days 1 and 8 of every 3 week cycle.

Continues until progressive disease, toxicity, noncompliance, or withdrawal.

Other Names:
  • IMC-11F8
  • LY3012211

1250 mg/m2 on Days 1 and 8 of every 3 week cycle.

Continues for a maximum of six cycles.

Other Names:
  • LY2334737

75 mg/m2 IV on Day 1 of every 3 week cycle.

Continues for a maximum of six cycles.

Active Comparator: Gemcitabine + Cisplatin

1250 mg/m2 on Days 1 and 8 of every 3 week cycle.

Continues for a maximum of six cycles.

Other Names:
  • LY2334737

75 mg/m2 IV on Day 1 of every 3 week cycle.

Continues for a maximum of six cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Time (OS)
Time Frame: Randomization to Death from Any Cause (Up to 31 Months)
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.
Randomization to Death from Any Cause (Up to 31 Months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
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.
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])
Time Frame: Baseline to Measured Progressive Disease (Up to 31 Months)
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.
Baseline to Measured Progressive Disease (Up to 31 Months)
Time to Treatment Failure (TTF)
Time Frame: Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)
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.
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)
Time Frame: Baseline, Cycle 6 (Cycle = 3 Weeks)
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).
Baseline, Cycle 6 (Cycle = 3 Weeks)
Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)
Time Frame: Baseline, Cycle 6 (Cycle = 3 Weeks)
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.
Baseline, Cycle 6 (Cycle = 3 Weeks)
Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)
Time Frame: 31 Months
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.
31 Months
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
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
Time Frame: Baseline through 31 Months
A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.
Baseline through 31 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2010

Primary Completion (Actual)

June 17, 2013

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimated)

September 22, 2009

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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