What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) involving immune checkpoint inhibitors and targeted therapies, such as pembrolizumab, nivolumab, and ipilimumab, often result in a range of side effects. These can include immune-related adverse events like skin reactions, endocrine disorders, and pneumonitis. Other frequent side effects are fatigue, diarrhea, and infusion-related reactions. Severe adverse events, though less common, can include pneumonia, acute kidney injury, and severe diarrhea. The combination of these therapies with chemotherapy can also increase the incidence of hematologic toxicities such as anemia and neutropenia.

What prior FDA approvals exist?

Several immune checkpoint inhibitors and targeted therapies have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, often combined with chemotherapy, has shown significant improvements in overall survival (OS) and progression-free survival (PFS) in various trials, such as KEYNOTE-407. Nivolumab, another immune checkpoint inhibitor, is approved for advanced NSCLC after failure of prior platinum-based chemotherapy. Atezolizumab, combined with chemotherapy and bevacizumab, has also been approved for advanced nonsquamous NSCLC, demonstrating improved PFS and OS in the IMpower 150 trial. These approvals highlight the efficacy of combining immune checkpoint inhibitors with chemotherapy in treating NSCLC.

What other types of research exist?

Promising novel alternatives to Volrustomig for NSCLC patients include: 1) Pembrolizumab plus chemotherapy, which has shown improved overall survival and progression-free survival in multiple trials. 2) Nivolumab plus ipilimumab, with or without chemotherapy, which has demonstrated efficacy in various settings. 3) Avelumab plus axitinib, which has shown superior response rates and progression-free survival in metastatic renal cell carcinoma and may be applicable to NSCLC. These treatments have demonstrated significant clinical benefits and are likely to be considered in 2024.

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Monoclonal Antibodies

Volrustomig + Chemotherapy for Advanced Non-Small Cell Lung Cancer (eVOLVE-Lung02 Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and targeted therapies. Immune checkpoint inhibitors, like pembrolizumab and nivolumab, block proteins such as PD-1 or PD-L1, enabling the immune system to better recognize and attack cancer cells. Targeted therapies focus on specific genetic mutations or proteins that drive cancer growth, such as EGFR or ALK inhibitors, and work by disrupting the molecular pathways essential for tumor development. These treatments are significant for NSCLC patients as they offer personalized and potentially more effective options based on the unique characteristics of their cancer.

Phase 3

Recruiting

Research Sponsored by AstraZeneca

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 up to approximately 6 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two treatments for advanced lung cancer. One uses a new drug called volrustomig with chemotherapy, and the other uses an existing drug called pembrolizumab with chemotherapy. Pembrolizumab has been widely used and approved for the treatment of advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy. The goal is to see which treatment helps the immune system fight cancer better in patients whose tumors lack certain genetic changes and have low PD-L1 levels.

Who is the study for?

This trial is for adults with stage IV non-small cell lung cancer (NSCLC) without certain genetic mutations or rearrangements. Candidates should not have a history of other cancers within the last 2 years, except some skin cancers and localized cancers that were treated. They must not have brain metastases requiring steroids or mixed NSCLC histology.

What is being tested?

The study compares two treatments: Volrustomig combined with chemotherapy versus Pembrolizumab (also known as Keytruda) with chemotherapy in patients whose tumors express PD-L1 <50%. The goal is to see which treatment works better for this specific group of lung cancer patients.

What are the potential side effects?

Possible side effects include immune-related reactions, fatigue, nausea, hair loss from chemotherapy, and potential allergic reactions to the drugs being tested. Side effects can vary based on individual patient health and response to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS), in PD-L1-negative participants.

Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)

Secondary study objectives

Concentration of volrustomig in serum and PK parameters

Duration of Response (DoR)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1Experimental Treatment4 Interventions

Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion

Group II: Arm 2Active Control4 Interventions

Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5370

Pemetrexed

2014

Completed Phase 3

~5550

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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and targeted therapies. Immune checkpoint inhibitors, like pembrolizumab and nivolumab, block proteins such as PD-1 or PD-L1, enabling the immune system to better recognize and attack cancer cells. Targeted therapies focus on specific genetic mutations or proteins that drive cancer growth, such as EGFR or ALK inhibitors, and work by disrupting the molecular pathways essential for tumor development. These treatments are significant for NSCLC patients as they offer personalized and potentially more effective options based on the unique characteristics of their cancer.