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Tyrosine Kinase Inhibitor
Aumolertinib monotherapy for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by EQRx International, Inc.
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 6 years
Awards & highlights
Summary
This trial is testing a new cancer drug called aumolertinib, alone and with chemotherapy, in people with a specific type of lung cancer. The drug aims to block a protein that helps cancer cells grow, potentially slowing or stopping the cancer. Aumolertinib is developed for treating advanced lung cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary study objectives
DCR as Assessed by the Investigator Per RECIST v1.1
DOR as Assessed by the Investigator Per RECIST v1.1
DepOR as Assessed by the Investigator Per RECIST v1.1
+17 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Aumolertinib monotherapyExperimental Treatment1 Intervention
Group II: Aumolertinib + platinum-based doublet chemotherapyExperimental Treatment7 Interventions
For adenocarcinoma, either:
* Aumolertinib + cisplatin with pemetrexed, or
* Aumolertinib + carboplatin with pemetrexed
For squamous cell carcinoma, one of the following:
* Aumolertinib + cisplatin or carboplatin with paclitaxel;
* Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or
* Aumolertinib + cisplatin or carboplatin with gemcitabine
Group III: Osimertinib monotherapyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab paclitaxel
2014
Completed Phase 2
~580
Gemcitabine
2017
Completed Phase 3
~1920
Paclitaxel
2011
Completed Phase 4
~5810
Cisplatin
2013
Completed Phase 3
~2360
Carboplatin
2014
Completed Phase 3
~6120
Pemetrexed
2014
Completed Phase 3
~5550
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Who is running the clinical trial?
EQRx International, Inc.Lead Sponsor
3 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe and ongoing nausea, vomiting, or digestive problems that may prevent you from properly taking the study medication.You have or had a lung disease that was caused by drugs or radiation and required treatment with steroids.You have a history of a heart condition called prolonged QT syndrome or Torsades de Pointes.You are allergic to aumolertinib or osimertinib or any of the ingredients they contain.You are eligible for treatment that aims to cure your non-small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Aumolertinib monotherapy
- Group 2: Aumolertinib + platinum-based doublet chemotherapy
- Group 3: Osimertinib monotherapy
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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