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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

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.

Timeline

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%
Arthralgia
11%
Dysgeusia
11%
Hypertension
11%
Headache
11%
Insomnia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Rash
7%
Dizziness
7%
Nail discolouration
6%
Dyspepsia
6%
Dysphonia
6%
Dehydration
6%
Productive cough
6%
Paraesthesia
6%
Pain
6%
Haemoptysis
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Hyponatraemia
1%
Lobar pneumonia
1%
Metastatic pain
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel

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
~1050
Erlotinib
2011
Completed Phase 4
~2290

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) often target specific molecular pathways involved in tumor growth and survival. Ramucirumab is a VEGFR-2 inhibitor that works by blocking the vascular endothelial growth factor receptor-2, thereby inhibiting angiogenesis, which is the formation of new blood vessels that tumors need to grow. On the other hand, EGFR inhibitors like Erlotinib, Gefitinib, and Osimertinib target the epidermal growth factor receptor (EGFR) pathway, which is often mutated in NSCLC. These drugs block the signaling pathways that promote cell proliferation and survival. For NSCLC patients, these targeted therapies are crucial as they can specifically attack cancer cells with fewer side effects compared to traditional chemotherapy, leading to improved progression-free survival and potentially better overall outcomes.
Angiogenesis and epidermal growth factor receptor inhibitors in non-small cell lung cancer.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,565 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
415,931 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
~54 spots leftby Jul 2025