A study, in which patients with late-stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.

Overview

Sponsor-declared trial summary

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

6 Sep 2013 → 9 Jan 2026

Decision date (initial)

2024-11-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-514268-18-00

EudraCT number

2012-005476-33

WHO UTN

U1111-1310-5818

ClinicalTrials.gov

NCT01897480

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Pharmacodynamic

The primary objective of this study is to compare PFS of LY2875358 plus erlotinib therapy with erlotinib monotherapy as first-line treatment in metastatic NSCLC patients with activating EGFRmt who have disease control after an 8-week lead-in treatment with erlotinib monotherapy.

Conditions and MedDRA coding

Non-Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Have a histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC at the time of study entry
2. Have at least 1 measurable lesion whose presence is assessable using standard techniques by RECIST version 1.1. For patients with prior radiation therapy, measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented at that site since radiation.
3. Have molecular evidence of an EGFRmt known to be associated with drug sensitivity (G719X, exon 19 deletion, L858R, L861Q; further activating EGFRmt may be included in the future if supported by scientific evidence after discussion with the sponsor). This determination should be made from a NSCLC tumor sample based on testing with an EGFRmt assay (either a regulatory approved assay or by a local assay validated in a local laboratory according to institutional guidelines and local standard of care).
4. Availability of adequate tumor-derived material from a biopsy or surgery (tumor blocks or slides) for analysis of MET expression status (needed for stratification) and exploratory biomarkers analysis.
5. Have a performance status of 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
6. Have not received previous systemic chemotherapy, systemic therapy with biologics, or molecular-targeted therapy for Stage IV NSCLC. Patients who received chemotherapy as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment are eligible.
7. Have adequate organ function
8. Patients who require oral anticoagulants (eg, warfarin) are eligible provided there is increased vigilance with respect to the monitoring of the patient’s international normalized ratio (INR), according to investigator judgment. If medically appropriate and the treatment is available, the investigator may also consider switching these patients to low-molecular-weight heparin, with which an interaction with LY2875358 or erlotinib is not expected.
9. Are men or women at least 18 years of age at the time of screening.
10. Eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy, or longer if required by local regulations.

Exclusion criteria 9

1. Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
2. Have previously completed or withdrawn from this study or any other study investigating LY2875358.
3. Have a serious concomitant systemic disorder, or significant cardiac disease, that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol.
4. Have interstitial pneumonia or interstitial fibrosis of the lung that, in the opinion of the investigator, could compromise the patient or the study treatment with erlotinib.
5. Have pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently.
6. Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study.
7. Have any major surgery less than 2 weeks prior to initiation of study treatment.
8. Have any condition (eg, psychological, geographical.) that does not permit compliance with study and follow-up procedures or suggests that the patient is, in the investigator?s opinion, not an appropriate candidate for the study.
9. Are pregnant or lactating women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the study is progression-free survival (PFS). PFS is defined as the time from the date of study randomization to the date of first observation of objective radiographic progression or death from any cause as defined by RECIST 1.1 (Eisenhauer et al. 2009). If a patient is event-free at analysis, the patient will be censored at the last progression-free tumor assessment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

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 12

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications