Overview
Sponsor-declared trial summary
Non Small Cell Lung Cancer
The primary objective of this study are to compare abemaciclib plus BSC versus erlotinib plus BSC with respect to overall survival (OS)
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Nov 2014 → ongoing
- Decision date (initial)
- 2023-10-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506779-82-00
- EudraCT number
- 2013-004662-33
- WHO UTN
- U1111-1295-7720
- ClinicalTrials.gov
- NCT02152631
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The primary objective of this study are to compare abemaciclib plus BSC versus erlotinib plus BSC with respect to overall survival (OS)
Conditions and MedDRA coding
Non Small Cell Lung Cancer
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participant must have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC)
- Participant must have a tumor with a KRAS mutation (this will be checked for at screening)
- Participant must have received prior chemotherapy
Exclusion criteria 2
- Participant must not have an active infection with HIV, Hepatitis B or C, or a history of cardiac arrest
- Female participant must not be pregnant or lactating
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall Survival (OS). [ Time Frame: 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD1578434 · Product
- Active substance
- Abemaciclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 89600 mg milligram(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
SCP816963 · ATC
- Active substance
- Erlotinib
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 33600 mg milligram(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EB02 — ERLOTINIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Code 10 |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Fortrea Inc. ORG-100012602
|
Princeton, United States | Other, Data management |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Data management |
| Parexel International Corp. ORG-100007310
|
Durham, United States | On site monitoring |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2014-11-04 | 2014-11-10 | 2017-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506779-82-00_Redacted | i |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC erlotinib | N/A |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR_ 2023-506779-82-00_Redacted | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-506779-82-00 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-17 | France | Acceptable 2023-09-06
|
2023-10-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-20 | France | Acceptable 2023-12-05
|
2023-12-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-17 | France | Acceptable 2023-12-05
|
2024-01-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-30 | France | Acceptable 2025-03-03
|
2025-03-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-19 | France | Acceptable 2025-03-03
|
2025-12-19 |