A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

6 May 2015 → 5 Feb 2026

Decision date (initial)

2024-08-21

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-514269-20-00

EudraCT number

2014-004824-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Part A and Part B
To evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B.
Part C
To determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.

Conditions and MedDRA coding

Metastatic 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 5

1. Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009).
2. Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation [exon 19 deletion or exon 21 (L858R) substitution mutation].
3. Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C (Ramucirumab + Gefitinib or Osimertinib)).
4. At least one measurable lesion.
5. Life expectancy of at least 3 months.

Exclusion criteria 13

1. Known T790M EGFR mutation (not applicable for Part C Period 2).
2. Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
3. Serious illness or medical condition.
4. Ongoing treatment with CYP3A4 inducers or strong inhibitors.
5. Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
6. History of gross hemoptysis.
7. Significant bleeding disorders.
8. Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
9. Radiographic evidence of intratumor cavitation.
10. History of gastrointestinal perforation within last 6 months.
11. History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
12. History of any arterial thrombotic event within 6 months prior to enrollment.
13. The participant has any known significant ophthalmologic abnormalities of the surface of the eye.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part B (Placebo + Erlotinib): Progression Free Survival (PFS) [ Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months) ]
2. Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: Cycle 1 Day 1 through End of Study (Up To 3 Years) ]

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 4

Locations

1 EU/EEA country · 4 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 7 files

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

Application history

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