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Chemotherapy

Dato-DXd + Durvalumab + Carboplatin for Advanced Non-Small Cell Lung Cancer (AVANZAR Trial)

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 approximately 4 years

Awards & highlights

AVANZAR Trial Summary

This trial compares two treatments for adults with advanced non-small cell lung cancer (NSCLC) without certain genetic alterations.

Who is the study for?

Adults over 18 with advanced non-small cell lung cancer (NSCLC) stages IIIB, IIIC, or IV without certain genetic changes can join. They should be in good physical condition (ECOG PS of 0 or 1), have not had previous systemic therapy for their cancer stage, and must have proper organ function and bone marrow reserve.Check my eligibility

What is being tested?

The trial is testing a new combination of drugs: Datopotamab Deruxtecan (Dato-DXd) with Durvalumab and Carboplatin against the standard treatment Pembrolizumab with platinum-based chemotherapy. It's to see which is better as a first-line treatment for NSCLC.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, potential lung issues like pneumonitis, and other organ inflammations.

AVANZAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 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 the TROP2 biomarker positive population

Progression-Free Survival (PFS) in the TROP2 biomarker positive population

Secondary outcome measures

Anti-Drug Antibody (ADA) for Dato-DXd

Clinical Outcome Assessments such as TTD in pulmonary symptoms (dyspnoea, cough and chest pain) as measured by the NSCLC-SAQ, and TTD in physical functioning as measured by PROMIS Physical Function short form 8c

Duration of Response (DoR) in the TROP2 biomarker positive and ITT populations

+8 more

Other outcome measures

Safety of Dato-DXd in combination with durvalumab and carboplatin

AVANZAR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dato-DXd + Durvalumab + CarboplatinExperimental Treatment3 Interventions

Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 1120 mg durvalumab plus carboplatin area under the curve [AUC] 5 mg/mL/minute.

Group II: Histologic-specific therapyActive Control5 Interventions

Non-squamous NSCLC participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m2 pemetrexed plus either AUC 5 mg/mL/minute carboplatin or 75 mg/m2 cisplatin. Squamous NSCLC participants will be randomized to receive 200 mg of pembrolizumab plus 200 mg/m2 paclitaxel plus AUC 5 or 6 mg/mL/minute carboplatin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Durvalumab

2017

Completed Phase 2

~3870

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,611,404 Total Patients Enrolled

Charu AggarwalStudy ChairPerelman Center for Advanced Medicine

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05687266 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Histologic-specific therapy, Dato-DXd + Durvalumab + Carboplatin

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05687266 — Phase 3

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05687266 — Phase 3

Frequently Asked Questions

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

Is the elderly population being enrolled in this experimental endeavor?

"This medical trial has a minimum age requirement of 18 and an upper limit of 130 for those hoping to participate."

Answered by AI

Are there still opportunities to participate in this research?

"According to records found on clinicaltrials.gov, this study is presently looking for patients; it was initially published December 29th 2022 and most recently edited January 17th 2023."

Answered by AI

How many individuals have enrolled to participate in this experiment?

"Affirmative. Clinicaltrials.gov confirms that recruitment for this medical trial, which was initially announced on December 29th 2022, is still ongoing. A total of 1 thousand patients are being sought across 42 different sites."

Answered by AI

Has the combination of Dato-DXd, Durvalumab, and Carboplatin gained FDA approval?

"Our team at Power has assessed the safety of Dato-DXd + Durvalumab + Carboplatin to be a 3 due to there being substantiated evidence for efficacy and multiple layers of data attesting to its safety from previous trials."

Answered by AI

To what extent is this clinical trial being administered in health centers?

"This trial is currently enrolling patients from 42 different sites, with prominent locations including Phoenix, Little Rock and Los Angeles. It is in the best interest of those who join to pick the site nearest them to reduce their travel burden."

Answered by AI

What profile of individual is most suitable for inclusion in this clinical trial?

"This clinical trial seeks to recruit 1000 participants between the ages of 18 and 130 diagnosed with non-small cell lung cancer. In addition, these patients must meet a range criteria that include an Eastern Cooperative Oncology Group Performance Status score of 0 or 1, lack EGFR tumour tissue mutation and ALK/ROS1 rearrangements, have no actionable driver oncogenes with approved therapies, possess adequate bone marrow reserve and organ function within 7 days before randomisation, have not been treated for another malignancy in the last 3 years (with exceptions), do not present small-cell lung cancer histologies or sarcom"

Answered by AI

What primary goals are being sought after with this experiment?

"This landmark trial will span a three-year period and is aimed at analysing the Overall Survival (OS) amongst TROP2 biomarker positive patients. Additional objectives include measuring Progression Free Survival in the ITT population, which encompasses OS until death due to any cause, PFS among the TROP2 biomarker negative group as measured by RECIST 1.1 BICR criteria, and ultimately overall survival within this same patient subset."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

2022. "Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05687266.

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