Squamous Non Small Cell Lung CancerPhase 2NCT01769391
A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing Necitumumab, Paclitaxel and Carboplatin in people with Squamous Non Small Cell Lung Cancer, run by Eli Lilly and Company at 51 sites in 6 countries.
Trial summary
The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Non Small Cell Lung Cancer
- What is being tested?
- Necitumumab, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 51 sitesin 6 countries
- Study dates
- Jan 2013to Jul 2017
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed squamous NSCLC
- Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
- Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
- Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments
Who cannot join
- Nonsquamous NSCLC
- Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
- Previous chemotherapy for NSCLC
- Major surgery or received any investigational therapy in the 4 weeks prior to randomization
- Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
- 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)
Trial locations and contacts
51 sites in 6 countries.
51 sites in 6 countries
United States33 sites
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Billings, Montana, 59101
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Charleston, South Carolina, 29425
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Chattanooga, Tennessee, 37404
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Cherry Hill, New Jersey, 08003
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Cincinnati, Ohio, 45242
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Colorado Springs, Colorado, 80907
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Columbia, South Carolina, 29210
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Eugene, Oregon, 97401
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Fleming Island, Florida, 32003
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Fort Myers, Florida, 33916
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Fort Worth, Texas, 76104
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Hackensack, New Jersey, 07601
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Jonesboro, Arkansas, 72401
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Kalamazoo, Michigan, 49007
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Lansing, Michigan, 48910
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Latham, New York, 12110
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Lincoln, Nebraska, 68510
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Los Angeles, California, 90048
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Louisville, Kentucky, 40202
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Macon, Georgia, 31201
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Marietta, Georgia, 30060
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Memphis, Tennessee, 38120
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Miami Beach, Florida, 33140
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Nashville, Tennessee, 37203
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Port Saint Lucie, Florida, 34952
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Richmond, Virginia, 23230
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Sacramento, California, 95816
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Savannah, Georgia, 31404
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St. Petersburg, Florida, 33705
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The Woodlands, Texas, 77380
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Valdosta, Georgia, 31602
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Wichita, Kansas, 67214
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Woodbury, Minnesota, 55125
Poland6 sites
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Głuchołazy, 48-340
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Olsztyn, 10-357
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Otwock, 05-400
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Poznan, 60-693
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Radom, 26-617
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Warsaw, 02-781
Germany4 sites
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Großhansdorf, 22927
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Heidelberg, 69126
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Immenhausen, 34376
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Münster, 48149
Mexico4 sites
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Chihuahua City, 31000
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León, 37000
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Mexico City, 6700
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Monterrey, 64000
South Korea3 sites
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Incheon, 405-760
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Seoul, 135-710
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Ulsan, 682-714
Russia1 site
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Saint Petersburg, 194291
About this study
Official title: A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.
- Conditions
- Squamous Non Small Cell Lung Cancer
- Being tested
- Necitumumab, Paclitaxel, Carboplatin
- Keywords
- NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NecitumumabDrug
Also called LY3012211, IMC-11F8
Administered IV
PaclitaxelDrug
Administered IV
CarboplatinDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Necitumumab +Paclitaxel+Carboplatin | Experimental | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. Receives: Drug: Necitumumab; Drug: Paclitaxel; Drug: Carboplatin |
| Paclitaxel + Carboplatin | Active comparator | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD. Receives: Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Baseline to Disease Progression or Death (Up to 24 Months)
Secondary outcomes (7)
Overall Survival (OS)
OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).
Measured: Randomization to Date of Death (Up to 24 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
Measured: Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)
Percentage of Participants With Anti Necitumumab Antibodies
Measured: Baseline to End of Cycle 6
Progression-Free Survival
Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.
Measured: Randomization to Progressive Disease or Death (Up to 24 Months)
Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).
Measured: Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)
Percent Change in Tumor Size (CTS)
CTS is defined as maximum percent change from baseline in the sum of target lesions.
Measured: Baseline to Progressive Disease or Death (Up to 24 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Measured: Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2015
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769391
- Sponsor's protocol ID
- 14790
- Other IDs
- I4X-MC-JFCL, 2012-003214-13
- Status last verified
- Sep 2019
- First submitted
- 14 Jan 2013
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01769391
- Acronym / sponsor ID
- 14790
- Conditions
- Squamous Non Small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Posted 5 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Necitumumab +Paclitaxel+Carboplatin | Experimental | Drug: Necitumumab, Drug: Paclitaxel, Drug: CarboplatinNecitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. |
| Paclitaxel + Carboplatin | Active comparator | Drug: Paclitaxel, Drug: CarboplatinPaclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed squamous NSCLC
- Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
- Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
- Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments
Key exclusion criteria (6 listed)
- Nonsquamous NSCLC
- Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
- Previous chemotherapy for NSCLC
- Major surgery or received any investigational therapy in the 4 weeks prior to randomization
- Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NecitumumabAlso: LY3012211, IMC-11F8Administered IV | Drug | Necitumumab +Paclitaxel+Carboplatin |
| PaclitaxelAdministered IV | Drug | Necitumumab +Paclitaxel+Carboplatin, Paclitaxel + Carboplatin |
| CarboplatinAdministered IV | Drug | Necitumumab +Paclitaxel+Carboplatin, Paclitaxel + Carboplatin |
Primary outcome
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
Time frame: Baseline to Disease Progression or Death (Up to 24 Months)
The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
7 secondary outcomes
Overall Survival (OS)
Time frame: Randomization to Date of Death (Up to 24 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
Time frame: Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)
Percentage of Participants With Anti Necitumumab Antibodies
Time frame: Baseline to End of Cycle 6
Progression-Free Survival
Time frame: Randomization to Progressive Disease or Death (Up to 24 Months)
Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
Time frame: Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)
Percent Change in Tumor Size (CTS)
Time frame: Baseline to Progressive Disease or Death (Up to 24 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Time frame: Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
51 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Necitumumab, Paclitaxel and Carboplatin in people with Squamous Non Small Cell Lung Cancer, run by Eli Lilly and Company at 51 sites in 6 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 4 inclusion and 6 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Poland, Germany, Mexico, South Korea and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 May 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?
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) (time frame: Baseline to Disease Progression or Death (Up to 24 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2019.