Non-Small Cell Lung Cancer Stage IVPhase 2NCT02450539

A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

A Phase 2 study testing Abemaciclib and Docetaxel in people with Non-Small Cell Lung Cancer Stage IV, run by Eli Lilly and Company at 51 sites in 13 countries.

Completed

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

Official record

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Trial summary

The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer Stage IV
What is being tested?: Abemaciclib and Docetaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 51 sitesin 13 countries
Study dates: 6 Aug 2015to 29 Jul 2020
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

Confirmed diagnosis of stage IV NSCLC.
Have progressed during or after platinum-based chemotherapy for advanced disease.
Have not received prior treatment with docetaxel.
Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material.
Have adequate organ function including hematology, renal, and liver.
Have good performance score (0-1).
Have measurable disease per RECIST 1.1.
Agree to use a reliable medically approved method of birth control.

Who cannot join

Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment administered is not known.
Are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
Have the presence of unstable central nervous system (CNS) metastasis.
Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.

Trial locations and contacts

51 sites in 13 countries.

Country

City, postcode or hospital

51 sites in 13 countries

United States5 sites

Highlands Oncology Group
Fayetteville, Arkansas, 72703
Vista Oncology Inc. PS
Olympia, Washington, 98502
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10461
Cancer Center of Kansas, P.A.
Wichita, Kansas, 67214

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Australia5 sites

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Camperdown, 2050
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Randwick, 2013
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South Brisbane, 4101
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Wollongong, 2500
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Woolloongabba, 4102

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Germany5 sites

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Berlin, 14165
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Cologne, 51109
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Gera, 07548
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Halle, 06120
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Heidelberg, 69126

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Poland5 sites

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Krakow, 31-202
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Lodz, 90-242
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Olsztyn, 10-357
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Poznan, 60-569
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Warsaw, 04-125

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Italy4 sites

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Bari, 70124
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Florence, 50134
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Monza, 20900
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Torino, 10043

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Romania4 sites

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Baia Mare, 430031
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Cluj-Napoca, 400015
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Cluj-Napoca, 400058
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Craiova, 200347

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South Korea4 sites

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Cheongju-si, 28644
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Seoul, 06351
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Seoul, 06591
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Ulsan, 44033

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Spain4 sites

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Barcelona, 08025
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Madrid, 28223
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Pamplona, 31008
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Seville, 41071

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Taiwan4 sites

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Taichung, 40447
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Taichung, 40705
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Tainan, 70403
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Taipei, 10048

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Ukraine4 sites

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Dnipropetrovsk, 49102
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Kharkiv, 61070
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Kryvyi Rih, 50048
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Vinnitsa, 21029

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France3 sites

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Paris, 75970
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Strasbourg, 67091
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Suresnes, 92150

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Hungary2 sites

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Budapest, 1121
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Győr, 9023

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Russia2 sites

St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
Saint Petersburg, 197758
Volgograd regional clinical oncology dispensary
Volzhsky, 404130

Other trials in Russia

About this study

Official title: A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

Conditions: Non-Small Cell Lung Cancer Stage IV
Being tested: Abemaciclib, Docetaxel
Keywords: patient reported outcomes (PRO), patient focused outcomes (PFO), biomarkers, CDK 4 and 6
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.

AbemaciclibDrug
Also called LY2835219
Administered orally
DocetaxelDrug
Administered IV

Study groups in NCT02450539
Study group	Role	What they receive
Abemaciclib	Experimental	200 milligram (mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Drug: Abemaciclib
Docetaxel	Active comparator	75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Drug: Docetaxel

What is being measured

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

Progression Free Survival (PFS)
PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.
Measured: Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)

Secondary outcomes (9)

Pharmacokinetics (PK): Clearance of Abemaciclib
Pharmacokinetics (PK): Clearance of Abemaciclib
Measured: Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
PK: Volume of Distribution of Abemaciclib
PK: Volume of Distribution of Abemaciclib
Measured: Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
Overall Survival (OS)
OS was defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as the data inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Measured: Baseline to Date of Death from Any Cause (Up To 28 Months)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Overall response was defined as the percentage of randomized participants achieving a best overall response (BoR) of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
Measured: Baseline to Objective Progression (Up To 6 Months)
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)
DCR is the percentage of randomized participants who achieved a complete response, partial response or stable disease using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Complete response (CR) is defined as the disappearance of all target and non-target lesions, and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Stable disease was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Measured: Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)
Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2
Worsening of ECOG performance status is the duration from randomization to ECOG PFS of >/=2. Participants without an ECOG PFS >/=2 are censored at last adequate post baseline ECOG Performance Status or randomization date (whichever is last).
The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5 - Dead
Measured: Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores
MDASI-LC included 33 items:6 interference and 27 symptom(3 lung-cancer (LC),8 brain tumor (BT),and 3 study-specific(headache,diarrhea, and rash).Analyzed endpoints were 9 constructs:3 single-items (headache,diarrhea,and rash) and 6 composites(interference+core,LC,core+LC,BT, and core+LC worst 5 baseline).Data for all 9 constructs were collected by an 11-point numeric rating scale anchored at 0(not present or does not interfere) and 10(as bad as you can imagine or interfered completely).The measurement range was 10 (maximum score-minimum score). Between-group difference in regression-predicted change from baseline were estimated for each specified construct. MMRM models included independent variables treatment,visit, treatment*visit,and baseline score. Group-level negative change from baseline indicated group improvement.
Measured: Baseline through End of Study (Up To 6 Months)
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Overall self-rated health was measured with a vertical 20 cm visual analog scale (VAS) anchored at 0 (worst health) and ranged through 100 (best health). Between-group differences in regression-predicted change from baseline score were estimated for VAS scores. MMRM models included independent variables treatment, visit, treatment*visit, and baseline score. Group-level negative change from baseline indicated group improvement.
Measured: Baseline to Measured Progressive Disease (Up To 6 Months)
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value
There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to.The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using UK weights,health dimensions(mobility,self-care,usual activities,pain/discomfort, and anxiety/depression) into a single index value;the dimensions are not separately scored.The index is marked missing when ≥1 dimensions are missing.The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death.The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index .MMRM models included independent variables treatment, visit, treatment*visit, and baseline score.Group-level negative change from baseline indicated group improvement.
Measured: Baseline to Measured Progressive Disease (Up To 6 Months)

Timeline

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

6 Aug 201529 Jul 2020

First posted21 May 2015 (estimated)
Study start6 Aug 2015
Primary completion31 Mar 2017
Study completion29 Jul 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung Cancer Stage IVStudies 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: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02450539
Sponsor's protocol ID: 15806
Other IDs: I3Y-MC-JPBX, 2014-004832-20, 2014
Status last verified: 15 Jul 2021
First submitted: 19 May 2015
Last updated: 13 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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.
Expanded access: Available

Publications

Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.
PubMed 41121745

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
ClinicalTrials.gov ID: NCT02450539
Acronym / sponsor ID: 15806
Conditions: Non-Small Cell Lung Cancer Stage IV
Keywords: patient reported outcomes (PRO), patient focused outcomes (PFO), biomarkers, CDK 4 and 6
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 6 Aug 2015 (actual)
Primary completion: 31 Mar 2017 (actual)
Study completion: 29 Jul 2020 (actual)
First posted: 21 May 2015 (estimated)
Results: Posted 26 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Abemaciclib	Experimental	Drug: Abemaciclib200 milligram (mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Docetaxel	Active comparator	Drug: Docetaxel75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Confirmed diagnosis of stage IV NSCLC.
Have progressed during or after platinum-based chemotherapy for advanced disease.
Have not received prior treatment with docetaxel.
Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material.
Have adequate organ function including hematology, renal, and liver.

Key exclusion criteria (4 listed)

Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment administered is not known.
Are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
Have the presence of unstable central nervous system (CNS) metastasis.
Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.

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
AbemaciclibAlso: LY2835219Administered orally	Drug	Abemaciclib
DocetaxelAdministered IV	Drug	Docetaxel

Primary outcome

Progression Free Survival (PFS)
Time frame: Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)
PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.

9 secondary outcomes

Pharmacokinetics (PK): Clearance of Abemaciclib
Time frame: Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
PK: Volume of Distribution of Abemaciclib
Time frame: Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose
Overall Survival (OS)
Time frame: Baseline to Date of Death from Any Cause (Up To 28 Months)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Time frame: Baseline to Objective Progression (Up To 6 Months)
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)
Time frame: Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)
Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2
Time frame: Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)
Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores
Time frame: Baseline through End of Study (Up To 6 Months)
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score
Time frame: Baseline to Measured Progressive Disease (Up To 6 Months)
Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value
Time frame: Baseline to Measured Progressive Disease (Up To 6 Months)

Results and safety

Results posted to the registry on 26 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abemaciclib	106	90
Docetaxel	53	46

Primary outcome: Progression Free Survival (PFS)

Time frame: Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months). Median (95% Confidence Interval). Unit: months

Measure	Abemaciclib n = 106	Docetaxel n = 53
Value	2.53 (1.68 to 2.89)	4.21 (2.79 to 5.65)

Abemaciclib vs Docetaxel: Hazard Ratio (HR): 1.765 (95% CI 1.165 to 2.672), p = 0.0068, Stratified log-rank test.

Population analysed: All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=19 and Docetaxel= 15.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up To 5 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abemaciclib	29 of 106 (27.4%)	94 of 106 (88.7%)	71 of 106
Docetaxel	17 of 52 (32.7%)	43 of 52 (82.7%)	35 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41121745Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung CancerLink provided by the sponsor.
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 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib and Docetaxel in people with Non-Small Cell Lung Cancer Stage IV, run by Eli Lilly and Company at 51 sites in 13 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 8 inclusion and 4 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 13 Aug 2021. 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, Australia, Germany, Poland, Italy and 8 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 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 26 Jun 2018). 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?

Progression Free Survival (PFS) (time frame: Baseline to Objective Progression or Death from Any Cause ( Up To 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 NCT02450539, 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 13 Aug 2021.