What side effects are associated with this type of intervention?

Common side effects of VEGFR-2 inhibitors like ramucirumab include hypertension, fatigue, diarrhea, and increased risk of bleeding and thromboembolic events. For EGFR inhibitors such as erlotinib, gefitinib, and osimertinib, typical side effects include rash, diarrhea, stomatitis, and liver enzyme abnormalities. These treatments can also cause more severe adverse effects like interstitial lung disease and cardiac issues, though these are less common. Patients should be closely monitored for these side effects to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for NSCLC that involve EGFR inhibitors and VEGFR inhibitors. Erlotinib and Gefitinib are EGFR inhibitors that have been approved for the treatment of NSCLC with specific EGFR mutations. Osimertinib, another EGFR inhibitor, is approved for NSCLC patients with T790M mutations who have progressed on prior EGFR therapy. Ramucirumab, a VEGFR-2 inhibitor, has been studied in combination with other agents for various cancers, including NSCLC. The combination of Ramucirumab with EGFR inhibitors like Erlotinib, Gefitinib, and Osimertinib is being explored to enhance treatment efficacy in patients with EGFR mutation-positive metastatic NSCLC.

What other types of research exist?

Promising alternatives to Ramucirumab in combination with EGFR inhibitors for NSCLC include: 1) Pembrolizumab (PD-1 inhibitor) in combination with chemotherapy, which has shown improved overall survival in patients with PD-L1 expression. 2) Atezolizumab (PD-L1 inhibitor) combined with bevacizumab and chemotherapy, which has demonstrated efficacy in patients with EGFR mutations. 3) Durvalumab (PD-L1 inhibitor) plus tremelimumab (CTLA-4 inhibitor) and chemotherapy, which has shown potential in improving progression-free survival. These alternatives offer different mechanisms of action and have shown promising results in clinical trials.

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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

Pivotal Trial

Summary

This trial is testing a new drug combination to treat patients with advanced lung cancer who have specific genetic changes. The treatment aims to stop cancer growth by cutting off its blood supply and blocking growth signals. One of the drugs being tested has shown significant survival benefits when combined with other treatments in advanced lung cancer.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Treatment-Emergent Adverse Events

Part B: Progression Free Survival (PFS)

Secondary study objectives

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%

Back pain

12%

Peripheral sensory neuropathy

11%

Headache

11%

Arthralgia

11%

Dysgeusia

11%

Insomnia

11%

Hypertension

11%

Asthenia

11%

Weight decreased

Abdominal pain

White blood cell count decreased

Pain in extremity

Oropharyngeal pain

Thrombocytopenia

Rash

Nail discolouration

Dizziness

Pain

Hyperglycaemia

Dysphonia

Dyspepsia

Dehydration

Paraesthesia

Haemoptysis

Productive cough

Pneumonia

Platelet count decreased

Bone pain

Chronic obstructive pulmonary disease

Metastatic pain

Hyponatraemia

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~1100

Erlotinib

2011

Completed Phase 4

~2290

Do I qualify?Apply below to find out

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.