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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00981058
Other study ID # 13909
Secondary ID CP11-0806I4X-IE-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 7, 2010
Est. completion date June 2024

Study information

Verified date March 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 improving participant disease than the standard chemotherapy combination alone.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1093
Est. completion date June 2024
Est. primary completion date June 17, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Australia ImClone Investigational Site East Bentleigh Victoria
Australia ImClone Investigational Site Garran New South Wales
Australia ImClone Investigational Site Geelong Victoria
Australia ImClone Investigational Site Westmead New South Wales
Australia ImClone Investigational Site Wollongong New South Wales
Austria ImClone Investigational Site Linz
Austria ImClone Investigational Site Wien
Austria ImClone Investigational Site Wien
Belgium ImClone Investigational Site Duffel
Belgium ImClone Investigational Site Liege
Belgium ImClone Investigational Site Namur
Brazil ImClone Investigational Site Barretos
Brazil ImClone Investigational Site Brasilia, Distrito Federal
Brazil ImClone Investigational Site Goiania
Brazil ImClone Investigational Site Ijui
Brazil ImClone Investigational Site Itajai
Brazil ImClone Investigational Site Lajeado
Brazil ImClone Investigational Site Porto Alegre/RS
Brazil ImClone Investigational Site Salvador
Brazil ImClone Investigational Site Santo Andre
Brazil ImClone Investigational Site Sao Paulo
Brazil ImClone Investigational Site São Paulo - SP
Canada ImClone Investigational Site Brampton Ontario
Canada ImClone Investigational Site Saint John New Brunswick
Canada ImClone Investigational Site Saskatoon Saskatchewan
Croatia ImClone Investigational Site Dubrovnik
Croatia ImClone Investigational Site Pula
Croatia ImClone Investigational site Zagreb
France ImClone Investigational Site Brest Cedex
France ImClone Investigational Site Caen
France ImClone Investigational Site Draguignan
France ImClone Investigational Site Grenoble
France ImClone Investigational Site Le Mans
France ImClone Investigational Site Le Mans Cedex
France ImClone Investigational Site Lille
France ImClone Investigational Site Lyon
France ImClone Investigational Site Marseille
France ImClone Investigational Site Paris
France ImClone Investigational Site Paris
France ImClone Investigational Site Paris
France ImClone Investigational Site Paris
France ImClone Investigational Site Rennes
France ImClone Investigational Site Saint-Jean
France ImClone Investigational Site Toulon Armées
Germany ImClone Investigational Site Berlin
Germany ImClone Investigational Site Essen
Germany ImClone Investigational Site Essen
Germany ImClone Investigational Site Frankfurt
Germany ImClone Investigational Site Gauting
Germany ImClone Investigational Site Großhansdorf
Germany ImClone Investigational Site Halle
Germany ImClone Investigational Site Hamburg
Germany ImClone Investigational Site Hamburg
Germany ImClone Investigational Site Heidelberg
Germany ImClone Investigational Site Hemer
Germany ImClone Investigational Site Hofheim
Germany ImClone Investigational Site Karlsruhe
Germany ImClone Investigational Site Lostau
Germany ImClone Investigational Site Löwenstein
Germany ImClone Investigational Site München
Germany ImClone Investigational Site Münster
Germany ImClone Investigational Site Regensburg
Germany ImClone Investigational Site Regensburg
Germany ImClone Investigational Site Ulm
Greece ImClone Investigational Site Athens
Greece ImClone Investigational Site Heraklion, Crete
Greece ImClone Investigational Site Patras
Greece ImClone Investigational Site Thessaloniki
Hungary ImClone Investigational Site Budapest
Hungary ImClone Investigational Site Budapest
Hungary ImClone Investigational Site Deszk
Hungary ImClone Investigational Site Farkasgyepü
Hungary ImClone Investigational Site Mosonmagyaróvár
Hungary ImClone Investigational Site Székesfehérvár
Hungary ImClone Investigational Site Szombathely
Hungary ImClone Investigational Site Törökbálint
Italy ImClone Investigational Site Aviano Pordenone
Italy ImClone Investigational Site Frosinone
Italy ImClone Investigational Site Genova
Italy ImClone Investigational Site Lido di Camaiore Lucca
Italy ImClone Investigational Site Milano
Italy ImClone Investigational Site Milano
Italy ImClone Investigational Site Monza
Italy ImClone Investigational Site Parma
Italy ImClone Investigational Site Perugia
Korea, Republic of ImClone Investigational Site Incheon
Korea, Republic of ImClone Investigational Site Jeonju-si
Korea, Republic of ImClone Investigational Site Seongnam
Korea, Republic of ImClone Investigational Site Seoul
Korea, Republic of ImClone Investigational Site Seoul
Korea, Republic of ImClone Investigational Site Seoul
Korea, Republic of ImClone Investigational Site Suwon
Philippines ImClone Investigational Site Cebu
Philippines ImClone Investigational Site Cebu City
Philippines ImClone Investigational Site Davao City
Philippines ImClone Investigational Site Makati City
Philippines ImClone Investigational Site Manila
Philippines ImClone Investigational Site Quezon City
Philippines ImClone Investigational Site Quezon City
Poland ImClone Investigational Site Olsztyn
Poland ImClone Investigational Site Otwock
Poland ImClone Investigational Site Poznan
Poland ImClone Investigational Site Radom
Poland ImClone Investigational Site Rzeszow
Poland ImClone Investigational Site Szczecin
Poland ImClone Investigational Site Torun
Poland ImClone Investigational Site Wroclaw
Portugal ImClone Investigational Site Coimbra
Portugal ImClone Investigational Site Lisboa
Portugal ImClone Investigational Site Lisboa
Portugal ImClone Investigational Site Porto
Romania ImClone Investigational Site Brasov
Romania ImClone Investigational Site Bucharest
Romania ImClone Investigational Site Bucharest
Romania ImClone Investigational Site Cluj-Napoca
Romania ImClone Investigational Site Craiova, Dolj
Romania ImClone Investigational Site Iasi
Romania ImClone Investigational Site Piatra Neamt
Romania ImClone Investigational Site Sibiu
Russian Federation ImClone Investigational Site Ivanovo
Russian Federation ImClone Investigational Site Kirov
Russian Federation ImClone Investigational Site Krasnodar
Russian Federation ImClone Investigational Site Moscow
Russian Federation ImClone Investigational Site Omsk
Russian Federation ImClone Investigational Site Smolensk
Russian Federation ImClone Investigational Site St. Petersburg
Russian Federation ImClone Investigational Site St. Petersburg
Russian Federation ImClone Investigational Site St. Petersburg
Russian Federation ImClone Investigational Site St. Petersburg
Russian Federation ImClone Investigational Site Ufa
Russian Federation ImClone Investigational Site Yaroslavl
Serbia ImClone Investigational Site Belgrade
Serbia ImClone Investigational Site Kragujevac
Serbia ImClone Investigational Site Nis
Serbia ImClone Investigational Site Sremska Kamenica
Singapore ImClone Investigational Site Singapore
Slovakia ImClone Investigational Site Bratislava
Slovakia ImClone Investigational Site Nitra
Slovakia ImClone Investigational Site Poprad
South Africa ImClone Investigational Site Bloemfontein Free State
South Africa ImClone Investigational Site Durban Kwazulu-Natal
South Africa ImClone Investigational Site Pretoria Gauteng
Spain ImClone Investigational Site Avila Castilla Y Leon
Spain ImClone Investigational Site Barcelona Cataluña
Spain ImClone Investigational Site Barcelona Cataluña
Spain ImClone Investigational Site Barcelona
Spain ImClone Investigational Site L'Hospitalet de Llobregat
Spain ImClone Investigational Site Madrid
Spain ImClone Investigational Site Madrid Communidad De Madrid
Spain ImClone Investigational Site Madrid Communidad De Madrid
Spain ImClone Investigational Site Majadahonda Communidad De Madrid
Spain ImClone Investigational Site Sevilla Andalucía
Spain ImClone Investigational Site Terrassa Cataluña
Taiwan ImClone Investigational Site Taichung
Taiwan ImClone Investigational Site Taichung
Thailand ImClone Investigational Site Chiang Mai
Thailand ImClone Investigational Site Songkhla
United Kingdom ImClone Investigational Site Aberdeen
United Kingdom ImClone Investigational Site Bournemouth
United Kingdom ImClone Investigational Site Dundee
United Kingdom ImClone Investigational Site Edinburgh
United Kingdom ImClone Investigational Site Guildford
United Kingdom ImClone Investigational Site Liverpool
United Kingdom ImClone Investigational Site London
United Kingdom ImClone Investigational Site Manchester
United Kingdom ImClone Investigational Site Manchester
United Kingdom ImClone Investigational Site Preston
United States ImClone Investigational Site Akron Ohio
United States ImClone Investigational Site Baltimore Maryland
United States ImClone Investigational Site Camp Hill Pennsylvania
United States ImClone Investigational Site Chandler Arizona
United States ImClone Investigational Site Fairfax Virginia
United States ImClone Investigational Site Fayetteville Arkansas
United States ImClone Investigational Site Galesburg Illinois
United States ImClone Investigational Site Goshen Indiana
United States ImClone Investigational Site Hazard Kentucky
United States ImClone Investigational Site Jefferson City Missouri
United States ImClone Investigational Site Lincoln Nebraska
United States ImClone Investigational Site Memphis Tennessee
United States ImClone Investigational Site New York New York
United States ImClone Investigational Site Sacramento California
United States ImClone Investigational Site Wichita Kansas

Sponsors (11)

Lead Sponsor Collaborator
Eli Lilly and Company ICON Clinical Research, Intertek, Laboratory Corporation of America, Medidata Solutions, Pacific Biomarkers, Parexel, PPD, Sysmex Inostics GmbH, Thermo Fisher Scientific FS, University of Colorado, Denver

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Croatia,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Randomization to Death from Any Cause (Up to 31 Months)
Secondary 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. Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)
Secondary 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. Baseline to Measured Progressive Disease (Up to 31 Months)
Secondary 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. Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)
Secondary 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). Baseline, Cycle 6 (Cycle = 3 Weeks)
Secondary 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. Baseline, Cycle 6 (Cycle = 3 Weeks)
Secondary 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. 31 Months
Secondary Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months
Secondary 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. Baseline through 31 Months
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