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Monoclonal Antibodies

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

Q: Are participants still being welcomed to this clinical trial?

This <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> treatment is not presently taking on participants, although the start date of November 30th 2023 and last update on August 2nd 2023 are noted. Nevertheless, there are more than a thousand clinical trials that currently require subjects for their research.

Q: What aims are being pursued by this research endeavor?

For the evaluation of this clinical trial, investigators will be monitoring overall survival (OS) in PD-L1-negative participants over a period stretching up to 6 years. Secondary metrics that are being assessed include progression free survival (PFS), per Investigator assessments according to RECIST 1.1 and overall response rate (ORR). OS is defined as time from randomization until death due to any cause while ORR refers to confirmed complete or partial responses determined by BICR evaluations using RECIST 1.1 criteria.

Q: Has Arm 1 obtained governmental authorization for its use?

Our analysts at Power rate the safety of Arm 1 as a 3 because there are multiple rounds of clinical data that back up its efficacy and security.

Q: How many medical centers are presently conducting this trial within the state?

46 centres across the world are currently running this trial, spanning from Linz to Calgary and Halifax. Aiming for a site close by can help reduce travel expenses if you choose to join in.

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

eVOLVE-Lung02 Trial Summary

This trial tests if a new drug combo is better than an existing one for lung cancer patients with PD-L1 < 50%.

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.Check my eligibility

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.See study design

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.

eVOLVE-Lung02 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Concentration of volrustomig in serum and PK parameters

Duration of Response (DoR)

+7 more

eVOLVE-Lung02 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

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Pemetrexed

2014

Completed Phase 3

~5250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,611,775 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05984277 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Arm 1, Arm 2

Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05984277 — Phase 3

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05984277 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being welcomed to this clinical trial?

"This experimental treatment is not presently taking on participants, although the start date of November 30th 2023 and last update on August 2nd 2023 are noted. Nevertheless, there are more than a thousand clinical trials that currently require subjects for their research."

Answered by AI

What aims are being pursued by this research endeavor?

"For the evaluation of this clinical trial, investigators will be monitoring overall survival (OS) in PD-L1-negative participants over a period stretching up to 6 years. Secondary metrics that are being assessed include progression free survival (PFS), per Investigator assessments according to RECIST 1.1 and overall response rate (ORR). OS is defined as time from randomization until death due to any cause while ORR refers to confirmed complete or partial responses determined by BICR evaluations using RECIST 1.1 criteria."

Answered by AI

Has Arm 1 obtained governmental authorization for its use?

"Our analysts at Power rate the safety of Arm 1 as a 3 because there are multiple rounds of clinical data that back up its efficacy and security."

Answered by AI

How many medical centers are presently conducting this trial within the state?

"46 centres across the world are currently running this trial, spanning from Linz to Calgary and Halifax. Aiming for a site close by can help reduce travel expenses if you choose to join in."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

2023. "A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05984277.

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