What is the mechanism of action of this treatment?

Osimertinib, an EGFR Tyrosine Kinase Inhibitor, selectively inhibits mutated EGFR, preventing cancer cell proliferation and survival. Amivantamab, a bispecific antibody, targets both EGFR and MET receptors, blocking pathways that promote tumor growth and resistance. These targeted therapies are crucial for NSCLC patients as they offer more effective and personalized treatment options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) like Osimertinib and Amivantamab have specific side effects. Osimertinib, an EGFR Tyrosine Kinase Inhibitor, often causes diarrhea and rash, with severe side effects like dyspnea and mucosal inflammation being less common. Amivantamab, a bispecific antibody targeting EGFR and MET, can lead to rash, paronychia, infusion-related reactions, peripheral edema, thromboembolism, interstitial lung disease, and thrombocytopenia. These side effects are consistent across different clinical trials and populations.

What prior FDA approvals exist?

Osimertinib has been FDA-approved for the treatment of NSCLC with EGFR mutations, particularly for patients with T790M mutation-positive advanced NSCLC who have progressed on prior EGFR TKI therapy. Other EGFR inhibitors like Erlotinib and Cetuximab have also been approved for NSCLC, although their efficacy varies based on EGFR mutation status. Amivantamab, targeting both EGFR and MET, represents a newer approach, and while specific FDA approval details for Amivantamab in NSCLC are not provided, it is being studied for its potential benefits in this context.

What other types of research exist?

Promising novel alternatives to Osimertinib and Amivantamab for NSCLC patients include: <ol> <li>Pembrolizumab plus chemotherapy: This combination has shown improved overall survival in patients with advanced, nonsquamous NSCLC across various PD-L1 expression levels.</li> <li></li> </ol> Nivolumab plus ipilimumab: This combination has demonstrated efficacy in improving overall survival in patients with PD-L1-positive tumors. 3. Atezolizumab plus chemotherapy: This combination has shown benefits in progression-free survival and overall survival, particularly in patients with high PD-L1 expression. 4. Investigational agents like Tazemetostat and Nilotinib, which are being explored for their efficacy in various cancer types, including NSCLC.

← Back to Search

Monoclonal Antibodies

Osimertinib + Amivantamab for Lung Cancer (OSTARA Trial)

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements.

Newly diagnosed locally advanced or metastatic NSCLC or recurrent non-squamous NSCLC, not amenable to curative surgery or radiotherapy.

Must not have

Active infection, including tuberculosis and infections with HBV (verified by known positive HBsAg result) or HCV.

Patient with protocol defined cardiac issue.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose of study intervention until death due to any cause. landmarks at 18 and 24 months. (approximately 52 months after the first participant is dosed)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two drugs, Osimertinib and Amivantamab, to treat a specific type of lung cancer. The study focuses on adults whose cancer has certain genetic changes and has either advanced locally or spread. Osimertinib works by stopping cancer cells from growing, while Amivantamab helps the immune system attack these cells. Osimertinib is a standard treatment for non-small cell lung cancer with EGFR mutations, and Amivantamab targets EGFR exon 20 insertion mutations, showing promise in early trials.

Who is the study for?

This trial is for adults with newly diagnosed or recurrent non-squamous Non-small Cell Lung Cancer (NSCLC) that can't be removed by surgery. Participants should have a life expectancy of more than 12 weeks, no prior advanced NSCLC treatment, and must not have certain health conditions like interstitial lung disease or heart problems.

What is being tested?

The study tests the combination of Osimertinib and Amivantamab as a first-line treatment for NSCLC patients with specific EGFR mutations. It aims to evaluate the safety and effectiveness of this drug duo in managing locally advanced or metastatic cancer.

What are the potential side effects?

Potential side effects may include allergic reactions to the drugs' components, issues related to infusion such as fever or chills, lung problems like difficulty breathing, skin reactions, gastrointestinal disturbances like nausea or diarrhea, and possible liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a tumor that is at least 10 mm large and can be measured by CT or MRI.

Select...

My lung cancer cannot be cured with surgery or radiation.

Select...

My tumor has a mutation known to respond to certain lung cancer treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have an active infection, including TB, hepatitis B, or hepatitis C.

Select...

I have a heart condition as defined by the study.

Select...

I have or had lung conditions needing steroid treatment.

Select...

I have received focused radiation recently or wider radiation affecting my bone marrow within the last month.

Select...

I am not taking any strong CYP 3A4 inducers.

Select...

I have not had major surgery or significant injury recently.

Select...

I have not had treatments like chemotherapy or immunotherapy for my advanced lung cancer.

Select...

I have not had any cancer treatments recently without a break before starting this study.

Select...

I had cancer before, but it was treated successfully over 2 years ago.

Select...

I have been treated with an EGFR-TKI before.

Select...

I cannot take osimertinib due to severe nausea, vomiting, gut issues, or past major bowel surgery.

Select...

I am not taking any medications known to cause heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose of study intervention until death due to any cause. landmarks at 18 and 24 months. (approximately 52 months after the first participant is dosed)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose of study intervention until death due to any cause. landmarks at 18 and 24 months. (approximately 52 months after the first participant is dosed)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of study intervention until death due to any cause. landmarks at 18 and 24 months. (approximately 52 months after the first participant is dosed) 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 adverse events (AEs)

Progression Free Survival (PFS)

Secondary study objectives

Duration of Response (DoR)

Objective Response Rate (ORR)

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Osimertinib+AmivantamabExperimental Treatment2 Interventions

Participants will receive osimertinib and amivantamab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1120

0 / 15Eligibility criteria met

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

Osimertinib, an EGFR Tyrosine Kinase Inhibitor, selectively inhibits mutated EGFR, preventing cancer cell proliferation and survival. Amivantamab, a bispecific antibody, targets both EGFR and MET receptors, blocking pathways that promote tumor growth and resistance. These targeted therapies are crucial for NSCLC patients as they offer more effective and personalized treatment options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options.MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer.