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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
Participants with histologically or cytologically documented NSCLC that is Stage IIIB or IIIC disease not amenable for surgical resection or definitive chemoradiation or Stage IV metastatic NSCLC disease at the time of randomisation, who have not received prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV
Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved therapies (actionable genomic alterations).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is at an advanced stage and I haven't had chemotherapy for it yet.
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My cancer does not have specific genetic changes often targeted by treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer tissue was collected before I agreed to this study.
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My blood and organs are working well.
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I am 18 years old or older.
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My lung cancer is at an advanced stage and I haven't had chemotherapy for it yet.
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My cancer does not have specific genetic changes that would respond to targeted therapy.
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I am fully active or can carry out light work.
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My cancer tissue was collected before I agreed to this study.
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My organs and bone marrow are functioning well.

AVANZAR Trial Timeline

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

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.

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
Durvalumab
2017
Completed Phase 2
~3870
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,222 Previous Clinical Trials
288,416,561 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: Dato-DXd + Durvalumab + Carboplatin, Histologic-specific therapy
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
~853 spots leftby Feb 2027