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Tyrosine Kinase Inhibitor

Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant 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

No Placebo-Only Group

Pivotal Trial

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

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 more

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.

Trial 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

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4