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Tyrosine Kinase Inhibitor

Ramucirumab + Erlotinib for Lung Cancer (RELAY Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 predose through follow-up (up to 37 months)

Awards & highlights

RELAY Trial Summary

This trial is evaluating the efficacy and safety of ramucirumab in combination with erlotinib or gefitinib as compared to placebo in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation.

Who is the study for?

This trial is for people with a specific type of advanced lung cancer (Stage IV NSCLC) that has not been treated before and has certain EGFR mutations. Participants must have a life expectancy of at least 3 months, one measurable lesion, and provide tissue samples. It's not for those with certain medical conditions like significant bleeding disorders or recent major blood vessel invasion by cancer.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of Ramucirumab combined with Erlotinib versus placebo combined with Erlotinib in treating lung cancer. Part C extends to test Ramucirumab with Gefitinib or Osimertinib in East Asian participants based on disease progression and mutation status.See study design

What are the potential side effects?

Possible side effects include high blood pressure, bleeding problems, poor wound healing, proteinuria (protein in urine), infusion-related reactions, fatigue, mouth sores, loss of appetite, diarrhea, acne-like rash which are common to drugs targeting blood vessels growth.

RELAY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 predose through follow-up (up to 37 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 predose through follow-up (up to 37 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 predose through follow-up (up to 37 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Treatment-Emergent Adverse Events

Part B: Progression Free Survival (PFS)

Secondary outcome measures

Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)

Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

Part B: Duration of Response (DoR)

+5 more

Side effects data

From 2016 Phase 3 trial • 1253 Patients • NCT01168973

46%

Fatigue

36%

Neutropenia

32%

Diarrhoea

30%

Decreased appetite

27%

Nausea

26%

Alopecia

24%

Dyspnoea

23%

Stomatitis

22%

Cough

22%

Anaemia

19%

Epistaxis

18%

Neutrophil count decreased

17%

Oedema peripheral

17%

Constipation

16%

Mucosal inflammation

16%

Pyrexia

14%

Lacrimation increased

14%

Vomiting

14%

Febrile neutropenia

13%

Myalgia

13%

Leukopenia

12%

Peripheral sensory neuropathy

12%

Back pain

11%

Hypertension

11%

Dysgeusia

11%

Insomnia

11%

Headache

11%

Arthralgia

11%

Asthenia

11%

Weight decreased

Abdominal pain

White blood cell count decreased

Oropharyngeal pain

Pain in extremity

Thrombocytopenia

Rash

Dizziness

Nail discolouration

Dehydration

Pain

Dyspepsia

Haemoptysis

Paraesthesia

Dysphonia

Productive cough

Hyperglycaemia

Pneumonia

Platelet count decreased

Bone pain

Hyponatraemia

Chronic obstructive pulmonary disease

Metastatic pain

Lobar pneumonia

Pleural effusion

Pneumothorax

Pulmonary embolism

Pulmonary haemorrhage

Syncope

Confusional state

Death

Atrial fibrillation

General physical health deterioration

Renal failure acute

100%

80%

60%

40%

20%

Study treatment Arm

Ramucirumab and Docetaxel

Placebo and Docetaxel

RELAY Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Ramucirumab + Gefitinib or OsimertinibExperimental Treatment3 Interventions

Part C: 10 mg/kg ramucirumab administered every 2 weeks intravenously (IV) + 250 mg Gefitinib or 80 mg Osimertinib daily orally. Ramucirumab and gefitinib administered during period 1. Ramucirumab and osimertinib administered during period 2.

Group II: Ramucirumab + ErlotinibExperimental Treatment2 Interventions

Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

Group III: Placebo + ErlotinibPlacebo Group2 Interventions

Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ramucirumab

2017

Completed Phase 3

~5050

Gefitinib

2005

Completed Phase 3

~2440

Osimertinib

2017

Completed Phase 4

~1010

Erlotinib

2011

Completed Phase 4

~2290

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,613 Previous Clinical Trials

3,200,384 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,344 Previous Clinical Trials

404,707 Total Patients Enrolled

Media Library

Erlotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02411448 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Ramucirumab + Gefitinib or Osimertinib, Ramucirumab + Erlotinib, Placebo + Erlotinib

Non-Small Cell Lung Cancer Clinical Trial 2023: Erlotinib Highlights & Side Effects. Trial Name: NCT02411448 — Phase 3

Erlotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02411448 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical condition is Ramucirumab most often prescribed as a treatment?

"Ramucirumab is an effective medical intervention for patients suffering from malignant neoplasms, adenocarcinoma, and disease progression after chemotherapy."

Answered by AI

Why was this research project undertaken?

"The purpose of this study is to assess the effect of lenalidomide on overall survival in patients with progressive disease or death from any cause. Secondary outcomes include Part B: Best Change From Baseline on the Lung cancer Symptom Scale (LCSS) and Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score. The goal is toNumber of Participants With Treatment-Emergent Adverse Events and Overall Survival (OS)."

Answered by AI

Are we still able to enroll people in this experiment?

"Unfortunately, this study is no longer recruiting patients as of April 18th, 2022. This is according to the clinicaltrials.gov listing, which also reports that the trial was originally posted on May 6th, 2015. However, there are over 2000 other trials that are still accepting patients."

Answered by AI

How many people are included in this clinical trial at most?

"Currently, this particular study is not recruiting any more patients. It was initially posted on May 6th, 2015 but the most recent edit occurred on April 18th, 2022. However, there are 1,961 other clinical trials for lung cancer and 222 for Ramucirumab that are still looking for participants."

Answered by AI

Does Ramucirumab have FDA approval for therapeutic use?

"Ramucirumab has been through multiple rounds of testing and there is some data supporting its efficacy, so it received a score of 3."

Answered by AI

Could you please tell us what other research has been conducted utilizing Ramucirumab?

"Ramucirumab was first studied 18 years ago at Mayo Clinic in Rochester. Including the original research, a total of 18875 studies have been completed. At the moment, there are 222 clinical trials actively recruiting participants, many of which are based in Edmonton, Alberta."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Ramucirumab Plus Erlotinib in Patients with Untreated, Egfr-mutated, Advanced Non-small-cell Lung Cancer (RELAY): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Nakagawa, Kazuhiko, Edward B Garon, Takashi Seto, Makoto Nishio, Santiago Ponce Aix, Luis Paz-Ares, Chao-Hua Chiu, et al.. 2019. “Ramucirumab Plus Erlotinib in Patients with Untreated, Egfr-mutated, Advanced Non-small-cell Lung Cancer (RELAY): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30634-5.

Clinical Lung CancerJournal

Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-blind Study of Erlotinib with Ramucirumab or Placebo in Patients with Epidermal Growth Factor Receptor Mutation-positive Metastatic Non–small-cell Lung Cancer

Garon, Edward B., Martin Reck, Luis Paz-Ares, Santiago Ponce, Jesus Corral Jaime, Oscar Juan, Ernest Nadal, et al.. 2017. “Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-blind Study of Erlotinib with Ramucirumab or Placebo in Patients with Epidermal Growth Factor Receptor Mutation-positive Metastatic Non–small-cell Lung Cancer”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2016.05.023.

Clinical Lung CancerJournal

Randomized, Double-blind Phase Ib/iii Study of Erlotinib with Ramucirumab or Placebo in Previously Untreated EGFR -mutant Metastatic Non–small-cell Lung Cancer (RELAY): Phase Ib Results

Reck, Martin, Edward B. Garon, Luis Paz-Ares, Santiago Ponce, Jesus Corral Jaime, Oscar Juan, Ernest Nadal, et al.. 2018. “Randomized, Double-blind Phase Ib/iii Study of Erlotinib with Ramucirumab or Placebo in Previously Untreated EGFR -mutant Metastatic Non–small-cell Lung Cancer (RELAY): Phase Ib Results”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2017.11.003.

The Lancet OncologyJournal