What side effects are associated with this type of intervention?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly EGFR Tyrosine Kinase Inhibitors like Osimertinib, often cause side effects such as diarrhea, rash, dry skin, and nail toxicity. Other EGFR TKIs, such as erlotinib and gefitinib, share similar side effects. Chemotherapy, frequently used in combination with TKIs, can result in nausea, fatigue, neutropenia, and increased infection risk. Immunotherapies can lead to immune-related adverse events, including colitis, pneumonitis, and dermatitis.

What prior FDA approvals exist?

Several EGFR tyrosine kinase inhibitors (TKIs) have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). These include erlotinib, gefitinib, and afatinib, which target specific mutations in the EGFR gene. Osimertinib, another EGFR TKI, is specifically approved for patients with NSCLC who have the T790M mutation, a common resistance mutation to earlier-generation EGFR inhibitors. Additionally, necitumumab, a monoclonal antibody targeting EGFR, is approved for use in combination with chemotherapy for metastatic squamous NSCLC. These treatments aim to inhibit the EGFR pathway, which is crucial in the proliferation and survival of cancer cells in EGFR-mutant NSCLC.

What other types of research exist?

Promising novel alternatives to Osimertinib for NSCLC patients include: 1) Amivantamab, a bispecific antibody targeting EGFR and MET, which has shown efficacy in patients with EGFR exon 20 insertion mutations. 2) Mobocertinib, an oral EGFR TKI specifically targeting exon 20 insertion mutations. 3) Lazertinib, another third-generation EGFR TKI, which is being studied in combination with Amivantamab. These alternatives are in various stages of clinical trials and have shown potential in overcoming resistance to earlier-generation EGFR TKIs.

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Osimertinib After Chemoradiation for Lung Cancer (LAURA Trial)

Phase 3

Waitlist Available

Led By Shun Lu, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations

Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 to 66 Gy)

Must not have

Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib

Symptomatic pneumonitis following chemoradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 45 months

Awards & highlights

Pivotal Trial

Summary

This trial tests osimertinib, a medication for certain lung cancers, in patients with stage III unresectable NSCLC who have specific EGFR mutations. Osimertinib aims to slow or stop cancer growth by blocking a protein involved in cancer cell growth.

Who is the study for?

This trial is for adults with stage III unresectable non-small cell lung cancer that has specific EGFR mutations and hasn't worsened after chemoradiation. Participants need a WHO performance status of 0 or 1, must use contraception if necessary, and have completed chemoradiation within the past 6 weeks. Exclusions include prior NSCLC treatments other than for stage III, inability to absorb the drug due to gastrointestinal issues, certain heart risks, uncontrolled diseases like hypertension, or severe systemic diseases.

What is being tested?

The LAURA study tests the effectiveness and safety of Osimertinib following chemoradiation therapy compared to a placebo in patients with a particular mutation-positive lung cancer. It's designed to see if this treatment can improve outcomes for these patients after initial therapy.

What are the potential side effects?

Osimertinib may cause side effects such as diarrhea, rashes, dry skin, nail changes, mouth sores; less commonly it can affect the lungs causing breathlessness or coughing (signs of possible lung inflammation), heart rhythm abnormalities (QTc prolongation), and could potentially interact with other drugs.

Eligibility Criteria

Inclusion Criteria

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

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My tumor has a specific EGFR mutation known to respond to certain treatments.

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I've had chemoradiation for cancer, including platinum-based chemo and specific radiation doses.

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My cancer did not worsen after receiving platinum-based chemoradiation.

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I am fully active or able to carry out light work.

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My lung cancer is advanced but cannot be removed with surgery.

Exclusion Criteria

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

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I have severe nausea, vomiting, or gut issues that make it hard for me to take pills.

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I have lung inflammation symptoms after chemoradiation.

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I have conditions or take medications that could affect my heart's rhythm.

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I do not have severe illnesses like uncontrolled high blood pressure, active bleeding disorders, or infections like hepatitis or HIV.

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I have not had major surgery within the last 4 weeks.

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I have had interstitial lung disease before receiving chemoradiation.

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My lung cancer is a mix of small cell and non-small cell types.

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I don't have severe side effects from previous cancer treatments.

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My bone marrow or organs are not functioning well.

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I have been treated with EGFR-TKI therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 45 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 45 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 45 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

Progression-free survival (PFS)

Secondary study objectives

Disease control rate (DCR)

Duration of response (DoR)

Incidence of Adverse Events (AEs)

+13 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OsimertinibExperimental Treatment1 Intervention

Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule.

Group II: Placebo OsimertinibPlacebo Group1 Intervention

Matching placebo for Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule

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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve targeting specific molecular pathways that drive cancer growth. EGFR Tyrosine Kinase Inhibitors (TKIs) like Osimertinib work by blocking the epidermal growth factor receptor (EGFR) pathway, which is frequently mutated in NSCLC. By inhibiting EGFR, these drugs prevent the activation of downstream signaling pathways that promote cell proliferation and survival. This targeted approach is crucial for NSCLC patients as it can lead to more effective and personalized treatment, reducing tumor growth and potentially improving survival rates. Other treatments may include chemotherapy, which targets rapidly dividing cells, and immunotherapy, which enhances the body's immune response against cancer cells.

Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Mutation: First Line Treatment and Beyond.