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Dato-DXd + Durvalumab + Carboplatin for Advanced Non-Small Cell Lung Cancer (AVANZAR Trial)
AVANZAR Trial Summary
This trial compares two treatments for adults with advanced non-small cell lung cancer (NSCLC) without certain genetic alterations.
AVANZAR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AVANZAR Trial Design
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Who is running the clinical trial?
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- My lung cancer is at an advanced stage and cannot be removed by surgery.I had cancer before, but it was treated successfully over 3 years ago with no signs of return.My cancer tissue was collected before I agreed to this study.My cancer does not have certain genetic changes that can be treated with specific drugs.My lung cancer is a mix of small-cell and non-small cell or is a sarcomatoid variant.I have a serious eye condition affecting my cornea.I still have side effects from cancer treatment that haven't improved.I do not have an infection needing IV drugs.I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.I am 18 years old or older.I am fully active or can carry out light work.I have had another type of cancer before.My bone marrow and organs are functioning well.I have spinal cord compression or active brain metastases.I have samples of my cancer tissue stored.I have had cancer spread to the lining of my brain and spinal cord.I do not have an active or uncontrolled hepatitis B or C infection.My blood and organs are working well.My cancer does not have specific genetic changes often targeted by treatment.My lung cancer is at an advanced stage and I haven't had chemotherapy for it yet.
- Group 1: Histologic-specific therapy
- Group 2: Dato-DXd + Durvalumab + Carboplatin
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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"
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."
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