NCT05493501

Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer

A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR Mutation (TREBLE)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: EQRx International, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aumolertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets EGFR mutations. The reason for this study is to learn whether adding chemotherapy to a new investigational drug called aumolertinib helps to slow or stop cancer growth in people with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will compare this new combination of drugs to osimertinib, given alone. Aumolertinib given alone will also be used in the study, and it will be looked at in comparison with osimertinib given alone. This is a randomized, open-label study with 3 different groups that are listed below. "Randomized" means the study treatment participants take will be chosen by chance (decided at random by a computer). "Open-label" means that the participant, the study doctor, and the Sponsor will know which study treatment each participant is receiving. Participants will be randomly assigned to one of the following 3 treatment groups: * Group 1: Treatment with aumolertinib alone, taken orally (by mouth) as a pill once a day. Around 100 participants will be randomly assigned to this group. * Group 2: Treatment with aumolertinib taken orally as a pill once a day, in combination with chemotherapy given intravenously (IV; through a needle placed in a vein) on the schedule provided by the study doctor. Around 200 participants will be randomly assigned to this group. * Group 3: Treatment with osimertinib alone, taken orally as a pill once a day. Around 200 participants will be randomly assigned to this group. Because there will be twice as many participants in Group 2 and Group 3 as in Group 1, the chance of a participant being randomly assigned to either of those groups is twice as likely as being assigned to Group 1. Participants can continue to receive study treatment as long as they have not withdrawn consent, as long as they choose to continue to receive study treatment and are judged by their doctor to continue to receive clinical benefit from receiving the study treatment, and as long as no other study treatment and/or study discontinuation criteria are met .

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Aumolertinib monotherapy	Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
DRUG	Osimertinib monotherapy	80 mg tablet administered orally, once daily
DRUG	Pemetrexed	Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy
DRUG	Cisplatin	Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
DRUG	Carboplatin	Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
DRUG	Paclitaxel	Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information.
DRUG	Nab paclitaxel	Administered by IV Infusion given over 4 fixed cycles per prescribing information.
DRUG	Gemcitabine	Administered by IV Infusion over 4 fixed cycles per prescribing information.

Timeline

• Start date: 2022-12-14
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2022-08-09
• Last updated: 2024-05-02
• Results posted: 2024-05-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study