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Non-small Cell Lung Cancer MetastaticPhase 2NCT02443337

A Study of LY3023414 and Necitumumab in Squamous Lung Cancer

A Phase 2 study testing LY3023414 and Necitumumab in people with Non-small Cell Lung Cancer Metastatic, run by Eli Lilly and Company at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main purpose of this study is to evaluate the safety and activity of the study drug known as LY3023414 in combination with necitumumab in participants with metastatic squamous non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer Metastatic
What is being tested?
LY3023414 and Necitumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
14 sitesUnited States
Study dates
Jul 2015to Sep 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 confirmed squamous advanced NSCLC (Stage IV).
  • Participants must have progressed on one prior line of platinum-based chemotherapy in the advanced or metastatic setting.
  • Measurable disease as measured by response evaluation criteria in solid tumors (RECIST) criteria v 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Able to swallow the study drugs whole.
  • Adequate organ function.
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 3 months following completion of study treatment.

Who cannot join

  • Participants who have received > 1 prior line of chemotherapy in the advanced or metastatic setting. (Immunotherapy will not be considered a line of chemotherapy.)
  • Prior treatment with a PI3K/mTOR inhibitor, epidermal growth factor receptor (EGFR) inhibitor, and/or necitumumab.
  • History of brain metastases unless irradiated ≥ 2 weeks prior to first study treatment and stable without requirement of corticosteroids.
  • Have serious pre-existing medical conditions.
  • Have insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics.
  • Women who are pregnant or breast-feeding.
Show all 13Show fewer
  • Clinically significant electrolyte imbalance ≥ Grade 2.
  • Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin and oral Xa inhibitors are allowed.
  • Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ≤ 28 days prior to Day 1 of Cycle 1.
  • Concurrent serious infection requiring parenteral antibiotic therapy.
  • Have a second primary malignancy that in the judgment of the investigator and Medical Monitor may affect the interpretation of results.
  • Have an active, known fungal, bacterial, and/or known viral infection.
  • History of arterial or venous embolism within 3 months prior to study enrollment. If the embolism occurred >3 and <6 months, the participant is eligible provided appropriate treatment according to institutional standard of care is ensured.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • University of Virginia Health

    Charlottesville, Virginia, 22908

  • Chattanooga Oncology Hematology

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care Inc.

    Cincinnati, Ohio, 45242

  • Comprehensive Cancer Care and Research Institute of Colorado

    Englewood, Colorado, 80113

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Southern Cancer Center, P.C.

    Mobile, Alabama, 36608

  • SMO Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Phase II Study of the Combination of LY3023414 and Necitumumab After First-Line Chemotherapy for Metastatic Squamous Non-small Cell Carcinoma of the Lung

The main purpose of this study is to evaluate the safety and activity of the study drug known as LY3023414 in combination with necitumumab in participants with metastatic squamous non-small cell lung cancer (NSCLC).

Being tested
LY3023414, Necitumumab

What participants receive

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

  • LY3023414Drug

    Administered orally

  • NecitumumabDrug

    Also called LY3012211, IMC-11F8

    Administered IV

Study groups in NCT02443337
Study groupRoleWhat they receive
LY3023414 + NecitumumabExperimental200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
Receives: Drug: LY3023414; Drug: Necitumumab

What is being measured

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

  1. Percentage of Participants With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at 6 Months: Disease Control Rate (DCR)

    RECIST v 1.1 was used to assess tumor response.The 6-month DCR was defined as the number of participants with PFS > 6 months (or 26 weeks, to accommodate the scheduled tumor assessment at week 24 be delayed by up to 2 weeks) divided by number of participants with baseline tumor assessment.

    Target Lesions:CR was defined as the disappearance of all target lesions. PR was at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest (nadir) sum of diameters since the treatment started.

    Non-Target Lesions:CR was defined as disappearance of all non-target lesions and normalization of tumor markers.All lymph nodes must be non-pathological in size (<10 millimeters(mm) short axis).SD was defined as the persistence of one or more non-target lesions and/or persistence of tumor marker level above the normal limits.

    Measured: 6 Months

Secondary outcomes (5)

  1. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

    RECIST v 1.1 was used to assess tumor response. ORR for a given participant was based on objective responses determined from data obtained up to: progression, the last evaluable assessment in the absence of progression, or initiation of subsequent anticancer therapy. Participants for whom an objective response cannot be determined or for who the best objective response is not evaluable (NE) were considered non-responders.

    Target Lesions: CR was defined as the disappearance of all target lesions. PR was at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Non-Target Lesions: CR was defined as disappearance of all non-target lesions and normalization of tumor markers. All lymph nodes must be non-pathological in size (<10 mm short axis). The ORR percentage was calculated as the number of participants with best objective response of CR or PR divided by the number of participants with measurable disease at baseline.

    Measured: Baseline to Objective Disease Progression or Initiation of Subsequent Anticancer Therapy (Up To 3 Months)

  2. Progression Free Survival (PFS)

    PFS was defined as the time from enrollment until the date of disease progression per RECIST v 1.1 or death by any cause.Participants who had not progressed or died at the time of assessment were censored at the time of the last date of tumor assessment.Participants who are enrolled but do not receive treatment and participants who have no evaluable visits will be censored on day 1.Participants who received new anti-cancer therapy before disease progression or death will be censored to the last tumor assessment date prior to the new anti-cancer therapy.

    Target Lesions:PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest(nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum.

    Non-Target Lesions(NTL):PD is defined as appearance of one or more new lesions and/or unequivocal progression of existing NTL.

    Measured: Enrollment to Measured Progressive Disease or Death from Any Cause (Up To 12 Months)

  3. Overall Survival (OS)

    OS was defined as the time from enrollment until the date of death by any cause. Participants lost follow up or did not die at the time of assessment were censored at the time of the last known alive date.

    Measured: Enrollment to Death from Any Cause (Up To 16 Months)

  4. Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3023414 and Necitumumab

    Minimum Concentration (Cmin) of LY3023414 and Necitumumab

    Measured: Cycle 1 Day 8, and Cycle 3 Day 8 (pre-dose, end of necitumumab infusion and 1 hour post-necitumumab infusion), Cycle 2 Day 1, Cycle 4 Day 1

  5. Pharmacokinetics: Maximum Concentration (Cmax) of LY3023414 and Necitumumab

    Maximum Concentration (Cmax) of LY3023414 and Necitumumab

    Measured: Cycle 1 Day 8, and Cycle 3 Day 8 (pre-dose, end of necitumumab infusion and 1 hour post-necitumumab infusion)

Timeline

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

  1. First posted13 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionSep 2017
  4. Study completionSep 2017

Why it stopped: The study stopped due to lack of efficacy.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02443337
Sponsor's protocol ID
15799
Other IDs
I6A-MC-CBBE
Status last verified
Jan 2018
First submitted
11 May 2015
Last updated
9 Dec 2020
Data monitoring committee
No
Individual data sharing
Yes: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3023414 and Necitumumab in people with Non-small Cell Lung Cancer Metastatic, run by Eli Lilly and Company at 14 sites in United States.

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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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 9 Dec 2020). 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 With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at 6 Months: Disease Control Rate (DCR) (time frame: 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 NCT02443337.

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 9 Dec 2020.

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