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Non Small Cell Lung CancerPhase 3INSPIRENCT00982111

First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin

A Phase 3 study testing Pemetrexed, Cisplatin and Necitumumab in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 101 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The research study is testing the investigational drug necitumumab 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 pemetrexed will be more effective in improving… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Pemetrexed, Cisplatin and Necitumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
633 participants
Where
101 sitesin 20 countries
Study dates
2 Nov 2009to 23 Dec 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer
  • Has Stage IV disease at the time of study entry
  • Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (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 an Eastern Cooperative Oncology Group performance status score of 0-2
  • Has adequate hepatic function
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  • Has adequate renal function
  • Has adequate hematologic function
  • If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method 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 participants 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

Who cannot join

  • Has squamous non small cell lung cancer
  • Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the Epidermal Growth Factor Hormone (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor
  • 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)
  • Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization
  • Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
  • Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible
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  • Has superior vena cava syndrome contraindicating hydration
  • Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
  • Has experienced myocardial infarction within 6 months prior to randomization
  • Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus
  • Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance
  • Has 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 The participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments
  • Is pregnant or breastfeeding
  • Has a known history of drug abuse
  • Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years

Trial locations and contacts

101 sites in 20 countries.

101 sites in 20 countries

Germany18 sites

  • ImClone Investigational Site

    Berlin, 12200

  • ImClone Investigational Site

    Essen, 45136

  • ImClone Investigational Site

    Frankfurt, 60487

  • ImClone Investigational Site

    Gauting, 82131

  • ImClone Investigational Site

    Großhansdorf, 22927

  • ImClone Investigational Site

    Halle, 06120

  • ImClone Investigational Site

    Hamburg, 21075

  • ImClone Investigational Site

    Heidelberg, 69126

  • ImClone Investigational Site

    Hemer, 58675

  • ImClone Investigational Site

    Hofheim, 65719

  • ImClone Investigational Site

    Karlsruhe, 76137

  • ImClone Investigational Site

    Lostau, 39291

  • ImClone Investigational Site

    Löwenstein, 74245

  • ImClone Investigational Site

    Mainz, 55131

  • ImClone Investigational Site

    München, 81675

  • ImClone Investigational Site

    Münster, 48149

  • ImClone Investigational Site

    Regensburg, 93053

  • ImClone Investigational Site

    Ulm, 89081

Other trials in Germany

Brazil11 sites

  • ImClone Investigational Site

    Barretos - SP, 14784-400

  • ImClone Investigational Site

    Brasilia, Distrito Federal, 70310-050

  • ImClone Investigational Site

    Goiania - GO, 74884-606

  • ImClone Investigational Site

    Ijuí, 98700-000

  • ImClone Investigational Site

    Itajaí, 88301-220

  • ImClone Investigational Site

    Lajeado, 95900-000

  • ImClone Investigational Site

    Porto Alegre/RS, 90610-000

  • ImClone Investigational Site

    Ribeirão Preto - SP, 14015-130

  • ImClone Investigational Site

    Salvador, 40050-410

  • ImClone Investigational Site

    Santo Andre - SP, 09090-780

  • ImClone Investigational Site

    São Paulo - SP, 01246-000

Other trials in Brazil

Russia8 sites

  • ImClone Investigational Site

    Ivanovo, 153013

  • ImClone Investigational Site

    Kirov, 610021

  • ImClone Investigational Site

    Omsk, 644013

  • ImClone Investigational Site

    Saint Petersburg, 194044

  • ImClone Investigational Site

    Saint Petersburg, 197022

  • ImClone Investigational Site

    Saint Petersburg, 198255

  • ImClone Investigational Site

    Ufa, 450054

  • ImClone Investigational Site

    Yaroslavi, 150054

Other trials in Russia

Spain8 sites

  • ImClone Investigational Site

    Barcelona, Catalonia, 08035

  • ImClone Investigational Site

    Barcelona, Catalonia, 08041

  • ImClone Investigational Site

    L'Hospitalet de Llobregat, 08908

  • ImClone Investigational Site

    Madrid, Communidad de Madrid, 28041

  • ImClone Investigational Site

    Madrid, Communidad de Madrid, 28050

  • ImClone Investigational Site

    Majadahonda, Communidad de Madrid, 28222

  • Imclone Investigational Site

    Seville, Andalusia, 41013

  • ImClone Investigational Site

    Terrassa, Catalonia, 08221

Other trials in Spain

Hungary7 sites

  • ImClone Investigational Site

    Budapest, 1125

  • ImClone Investigational Site

    Budapest, 1145

  • ImClone Investigational Site

    Deszk, 6772

  • ImClone Investigational Site

    Mosonmagyaróvár, 9200

  • ImClone Investigational Site

    Székesfehérvár, 8000

  • ImClone Investigational Site

    Szombathely, 9700

  • ImClone Investigational Site

    Törökbálint, 2045

Other trials in Hungary

Italy7 sites

  • ImClone Investigational Site

    Aviano, Pordenone, 33081

  • ImClone Investigational Site

    Frosinone, 03100

  • ImClone Investigational Site

    Genova, 16132

  • ImClone Investigational Site

    Lido di Camaiore, Lucca, 55041

  • ImClone Investigational Site

    Milan, 20133

  • ImClone Investigational Site

    Parma, 43100

  • ImClone Investigational Site

    Perugia, 06126

Other trials in Italy

Romania7 sites

  • ImClone Investigational Site

    Brasov, 500366

  • ImClone Investigational Site

    Bucharest, 022328

  • ImClone Investigational Site

    Bucharest, 030171

  • ImClone Investigational Site

    Cluj-Napoca, 400015

  • ImClone Investigational Site

    Craiova, Dolj, 200385

  • ImClone Investigational Site

    Iași, 700106

  • ImClone Investigational Site

    Sibiu, 550245

Other trials in Romania

Poland6 sites

  • ImClone Investigational Site

    Olsztyn, 10-357

  • ImClone Investigational Site

    Otwock, 05-400

  • ImClone Investigational Site

    Poznan, 60-569

  • ImClone Investigational Site

    Radom, 26-617

  • ImClone Investigational Site

    Szczecin, 70-891

  • ImClone Investigational Site

    Wroclaw, 53-439

Other trials in Poland

United Kingdom6 sites

  • ImClone Investigational Site

    Aberdeen, AB25 2ZN

  • ImClone Investigational Site

    Bournemouth, BH7 7DW

  • ImClone Investigational Site

    Edinburgh, EH4 2XU

  • ImClone Investigational Site

    Guildford, GU2 7XX

  • ImClone Investigational Site

    Leeds, LS16 6QB

  • ImClone Investigational Site

    Preston, PR2 9HT

Other trials in United Kingdom

Australia3 sites

  • ImClone Investigational Site

    East Bentleigh, Victoria, 3165

  • ImClone Investigational Site

    Hobart, Tasmania, 7000

  • ImClone Investigational Site

    Kogarah, New South Wales, 2217

Other trials in Australia

Austria3 sites

  • ImClone Investigational Site

    Rankweil, 6830

  • ImClone Investigational Site

    Vienna, 1090

  • ImClone Investigational Site

    Vienna, 1130

Other trials in Austria

Belgium3 sites

  • ImClone Investigational Site

    Duffel, 2570

  • ImClone Investigational Site

    Liège, 4000

  • ImClone Investigational Site

    Namur, 5000

Other trials in Belgium

Greece3 sites

  • ImClone Investigational Site

    Athens, 11527

  • ImClone Investigational Site

    Heraklion, Crete, 71110

  • ImClone Investigational Site

    Pátrai, 26500

Other trials in Greece

France2 sites

  • ImClone Investigational Site

    Caen, 14076

  • ImClone Investigational Site

    Paris, 75571

Other trials in France

Portugal2 sites

  • ImClone Investigational Site

    Coimbra, 3041-801

  • ImClone Investigational Site

    Lisbon, 1649-035

Other trials in Portugal

Slovakia2 sites

  • ImClone Investigational Site

    Bratislava, 826 06

  • ImClone Investigational Site

    Nitra, 949 88

Other trials in Slovakia

South Africa2 sites

  • ImClone Investigational Site

    Bloemfontein, Free State, 9301

  • ImClone Investigational Site

    Pretoria, Gauteng, 0001

Other trials in South Africa

United States1 site

  • ImClone Investigational Site

    Nyack, New York, 10960

Other trials in United States

Canada1 site

  • ImClone Investigational Site

    Montreal, Quebec, H3T 1E2

Other trials in Canada

Croatia1 site

  • ImClone Investigational Site

    Pula, 52100

Other trials in Croatia

About this study

Official title: A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

The research study is testing the investigational drug necitumumab 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 pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.

Read the detailed description

Multinational, randomized, multicenter, open-label Phase 3 study of 633 participants with advanced, nonsquamous (Stage IV) NSCLC. Participants will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of pemetrexed and cisplatin in study Arm A, or first-line pemetrexed-cisplatin chemotherapy alone in 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 (computed tomography or magnetic resonance imaging) of disease status 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.

Being tested
Pemetrexed, Cisplatin, Necitumumab
Keywords
Nonsquamous, Non Small Cell Lung Cancer, First line treatment, Monoclonal, Antibodies, Epidermal Growth Factor Receptor (EGFR)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemetrexedDrug

    Also called Alimta®, LY231514

    500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles

  • CisplatinDrug

    75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

  • NecitumumabBiological

    Also called IMC-11F8, LY3012211, Portrazza®

    800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.

Study groups in NCT00982111
Study groupRoleWhat they receive
Necitumumab + Pemetrexed + CisplatinExperimentalNecitumumab + Pemetrexed + Cisplatin
Receives: Drug: Pemetrexed; Drug: Cisplatin; Biological: Necitumumab
Pemetrexed + CisplatinActive comparatorPemetrexed + Cisplatin
Receives: Drug: Pemetrexed; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival Time (OS)

    OS 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 using the Kaplan-Meier method.

    Measured: Randomization to Death from Any Cause (Up to 31.6 Months)

Secondary outcomes (9)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be 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 participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.

    Measured: Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)

  2. Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])

    ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.

    Measured: Baseline to Measured Progressive Disease (Up to 30.4 Months)

  3. Time to Treatment Failure (TTF)

    TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.

    Measured: Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)

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

    Measured: Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks

  5. Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)

    A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.

    Measured: Baseline to Study Completion (Up to 31.6 Months)

  6. Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)

    The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).

    Measured: Baseline, Cycle 6 (Cycle = 3 weeks)

  7. Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)

    The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.

    Measured: Baseline, Cycle 6 (Cycle =3 Weeks)

  8. Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)

    EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.

    Measured: Baseline

  9. Percentage of Participants With EGFR Measured by IHC

    EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2009 (estimated)
  2. Study start2 Nov 2009
  3. Primary completion14 Nov 2012
  4. Study completion23 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
633 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00982111
Sponsor's protocol ID
13908
Other IDs
2009-012574-12, CP11-0805, I4X-IE-JFCB, 2009
Acronym
INSPIRE
Status last verified
Dec 2021
First submitted
18 Sep 2009
Last updated
11 Jan 2022
Data monitoring committee
Yes
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and assigned data sharing agreement.

Publications

  • Paz-Ares L, Mezger J, Ciuleanu TE, Fischer JR, von Pawel J, Provencio M, Kazarnowicz A, Losonczy G, de Castro G Jr, Szczesna A, Crino L, Reck M, Ramlau R, Ulsperger E, Schumann C, Miziara JE, Lessa AE, Dediu M, Balint B, Depenbrock H, Soldatenkova V, Kurek R, Hirsch FR, Thatcher N, Socinski MA; INSPIRE investigators. Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study. Lancet Oncol. 2015 Mar;16(3):328-37. doi: 10.1016/S1470-2045(15)70046-X. Epub 2015 Feb 18.

    PubMed 25701171

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pemetrexed, Cisplatin and Necitumumab in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 101 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in Germany, Brazil, Russia, Spain, Hungary and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival Time (OS) (time frame: Randomization to Death from Any Cause (Up to 31.6 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00982111, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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