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Aumolertinib for Non-Small Cell Lung Cancer

Memorial Cancer Institute, Pembroke Pines, FL
Non-Small Cell Lung CancerAumolertinib - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new cancer drug against other existing treatments to see if it is more effective and has fewer side effects. It will last for about 5 years, and patients can keep receiving the treatment if it is helping them.

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
LY3537982
1
Lead-in Phase
1
sapanisertib

Study Objectives

2 Primary · 26 Secondary · Reporting Duration: Up to 6 years

6 weeks
Rate of circulating tumor DNA (ctDNA) clearance
Year 5
Disease Control Rate (DCR)
Year 5
Progression Free Survival (PFS)
Year 5
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with laboratory abnormalities
Number of participants with serious adverse events (SAEs)
Number of participants with treatment emergent adverse events (TEAEs)
Year 5
To assess safety in study treatment arms
Up to 5 years
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
Depth of Response (DepOR) as assessed by BICR per RECIST v1.1
Disease Control Rate (DCR) as assessed by BICR per RECIST v1.1
Duration of Response (DOR)
Duration of Response (DOR) as assessed by BICR per RECIST v1.1
ORR as assessed by the investigator per RECIST v1.1
Objective Response Rate (ORR)
Objective Response Rate (ORR) as assessed by BICR per RECIST v1.1
PFS as assessed by the investigator per RECIST v1.1
Progression Free Survival (PFS) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Quality of life as assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) questionnaire
TGR as assessed by the investigator per RECIST v1.1
Tumor Growth Rate (TGR) as assessed by BICR per RECIST v1.1
Tumor Response
ctDNA Clearance
Up to 6 years
Overall Survival (OS)
Month 5
Plasma concentration of aumolertinib
Plasma concentration of aumolertinib metabolite

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
LY3537982
2
Lead-in Phase
2
sapanisertib

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

6 Treatment Groups

Osimertinib monotherapy
1 of 6
Osimertinib alone (approximately 140 participants)
1 of 6
Aumolertinib monotherapy
1 of 6
Aumolertinib + platinum-based doublet chemotherapy
1 of 6
Aumolertinib + Chemotherapy (approximately 140 participants)
1 of 6
Aumolertinib alone (approximately 140 participants)
1 of 6

Active Control

Experimental Treatment

500 Total Participants · 6 Treatment Groups

Primary Treatment: Aumolertinib · No Placebo Group · Phase 3

Aumolertinib monotherapy
Drug
Experimental Group · 1 Intervention: Aumolertinib monotherapy · Intervention Types: Drug
Aumolertinib + platinum-based doublet chemotherapyExperimental Group · 7 Interventions: Nab paclitaxel, Carboplatin, Gemcitabine, Cisplatin, Aumolertinib monotherapy, Paclitaxel, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Aumolertinib + Chemotherapy (approximately 140 participants)
Drug
Experimental Group · 1 Intervention: Aumolertinib · Intervention Types: Drug
Aumolertinib alone (approximately 140 participants)
Drug
Experimental Group · 1 Intervention: Aumolertinib · Intervention Types: Drug
Osimertinib monotherapy
Drug
ActiveComparator Group · 1 Intervention: Osimertinib monotherapy · Intervention Types: Drug
Osimertinib alone (approximately 140 participants)
Drug
ActiveComparator Group · 1 Intervention: Osimertinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab paclitaxel
2020
Completed Phase 2
~50
Carboplatin
2014
Completed Phase 3
~6500
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1920
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed
2014
Completed Phase 3
~4270

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 years

Who is running the clinical trial?

EQRx International, Inc.Lead Sponsor
3 Previous Clinical Trials
332 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

How many locations are responsible for administering this clinical trial?

"The trial is based in four locations: Highlands Oncology Group in Springdale, Arkansas; QCCA - Mission Blood & Cancer in Des Moines, Iowa; SCRI - Tennessee Oncology- Nashville in Nashville, Tennessee; and 5 other sites." - Anonymous Online Contributor

Unverified Answer

Are there any long-term repercussions to Aumolertinib?

"Aumolertinib's safety is estimated to be a 3. This drug has progressed to Phase 3 clinical trials, which means that while there is data supporting its efficacy, repeated rounds of testing have also supported its safety." - Anonymous Online Contributor

Unverified Answer

Are new recruits being sought for this experiment?

"That is correct. The clinical trial's page on clinicaltrials.gov reveals that the research is ongoing and still looking for 420 individuals from 5 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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