Trial · NCT02152631
A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer
NCT02152631, Phase 3, Active not recruiting, Eli Lilly and Company; results first posted 2018-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer. Trials, record NCT02152631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02152631
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer
- NCT number
- NCT02152631
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 453 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Abemaciclib, Erlotinib
- First posted
- 2014-06-02
- Last updated
- 2026-02-06
- Other registries' IDs
- eudract:2013-004662-33
- Results first posted
- 2018-12-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From Randomization Date to Date of Death from Any Cause (Up to 32 Months) | OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. |
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | From Randomization Date to Objective Progression (Up to 32 Months) | ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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. |
| Secondary | Progression Free Survival (PFS) | From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months) | PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. |
| Secondary | Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score | From Randomization Date through End of Study (Up to 32 Months) | The MDASI-LC included 22 items + 3 additional trial-specific items, resulting in 6 collected and reported single-construct scores including core symptoms (13-item), interference (6-item), lung cancer (3-item), and trial-specific single outcomes for headache, diarrhea, and rash. A 2-construct composite core + lung cancer symptom (16-item) score was calculated. Data for all 7 scores 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). Mixed Model Repeated Measure (MMRM) regression with covariates for treatment, visit, treatment\*visit, and baseline score predicted between-group Least Squares (LS) mean differences from baseline. Group-level negative change from baseline indicated group improvement. |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State | Day 1 of Cycle 1 through Cycle 3 (28 Day Cycles) | PK is determined by the area under the plasma concentration versus time curve during 1 dosing interval at steady state |
| Secondary | Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score | From Randomization Date through End of Study (Up to 32 Months) | 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 United Kingdom (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. LS Mean value was controlled for Treatment, visit, Treatment\*Visit and baseline. |
| Secondary | Resource Utilization: Percentage of Participants Who Are Hospitalized | From Randomization Date through End of Study (Up to 32 Months) | Resource utilization is the percentage of participants who was hospitalized. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From Randomization Date to Date of Death from Any Cause (Up to 32 Months) | All randomized participants. 81 participants were censored in the Abemaciclib arm and 56 participants were censored in the Erlotinib arm. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | From Randomization Date to Objective Progression (Up to 32 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months) | All randomized participants. 36 participants were censored in the abemaciclib arm and 24 were censored in the erlotinib arm. | months | NUMBER |
| SECONDARY | Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score | From Randomization Date through End of Study (Up to 32 Months) | All randomized participants for cycles which at least 25% of participants in each arm have a score. MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC result. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State | Day 1 of Cycle 1 through Cycle 3 (28 Day Cycles) | All randomized participants who received Abemaciclib and had evaluable PK data. | Hour*nanogram/milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score | From Randomization Date through End of Study (Up to 32 Months) | All randomized participants who received at least one dose of study drug and with a baseline and at least 1 post-baseline result. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Resource Utilization: Percentage of Participants Who Are Hospitalized | From Randomization Date through End of Study (Up to 32 Months) | All randomized participants. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Abemaciclib | 7.4 | 95% Confidence Interval 6.5 to 8.8 | months | |
| Overall Survival (OS) | Erlotinib | 7.8 | 95% Confidence Interval 6.4 to 9.5 | months | |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | Abemaciclib | 8.9 | 95% Confidence Interval 5.5 to 12.3 | percentage of participants | |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | Erlotinib | 2.7 | 95% Confidence Interval 0.4 to 5.1 | percentage of participants | |
| Progression Free Survival (PFS) | Abemaciclib | 3.6 | 95% Confidence Interval 2.8 to 3.8 | months | |
| Progression Free Survival (PFS) | Erlotinib | 1.9 | 95% Confidence Interval 1.9 to 2.0 | months | |
| Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score | Abemaciclib | Headache | 0.20 | Standard Error 0.11 | units on a scale |
| Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score | Erlotinib | Headache | 0.27 | Standard Error 0.15 | units on a scale |
| Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score | Abemaciclib | Diarrhea | 1.91 | Standard Error 0.17 | units on a scale |
| Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score | Erlotinib | Diarrhea | 1.32 | Standard Error 0.23 | units on a scale |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abemaciclib | 270 | |
| Overall Study | STARTED | Erlotinib | 183 | |
| Overall Study | Received at Least One Dose of Study Drug | Abemaciclib | 265 | |
| Overall Study | Received at Least One Dose of Study Drug | Erlotinib | 175 | |
| Overall Study | Off Treatment | Abemaciclib | 246 | |
| Overall Study | Off Treatment | Erlotinib | 172 | |
| Overall Study | Death Due to Any Cause | Abemaciclib | 30 | |
| Overall Study | Death Due to Any Cause | Erlotinib | 20 | |
| Overall Study | Progressive Disease | Abemaciclib | 174 | |
| Overall Study | Progressive Disease | Erlotinib | 137 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events322
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Abemaciclib | 87 | 265 | 163 |
| other | Anaemia | Blood and lymphatic system disorders | Erlotinib | 23 | 175 | 30 |
| other | Neutropenia | Blood and lymphatic system disorders | Abemaciclib | 19 | 265 | 44 |
| other | Neutropenia | Blood and lymphatic system disorders | Erlotinib | 1 | 175 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Abemaciclib | 17 | 265 | 25 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Erlotinib | 1 | 175 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Abemaciclib | 30 | 265 | 34 |
| other | Abdominal pain | Gastrointestinal disorders | Erlotinib | 8 | 175 | 8 |
| other | Constipation | Gastrointestinal disorders | Abemaciclib | 29 | 265 | 32 |
| other | Constipation | Gastrointestinal disorders | Erlotinib | 15 | 175 | 17 |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abemaciclib | 186 | 265 |
| Total, all-cause mortality | Erlotinib | 123 | 175 |
| Total, other adverse events | Abemaciclib | 247 | 265 |
| Total, other adverse events | Erlotinib | 161 | 175 |
| Total, serious adverse events | Abemaciclib | 112 | 265 |
| Total, serious adverse events | Erlotinib | 43 | 175 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Abemaciclib vs Erlotinib: deaths from any cause | Trial comparisons |
| Abemaciclib vs Erlotinib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02152631
GET https://conductscience.org/api/trials/v1/NCT02152631/results?page=2