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

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Participants can continue to receive study treatment as long as they have not withdrawn consent, as long as they choose to continue to receive study treatment and are judged by their doctor to continue to receive clinical benefit from receiving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

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.

Sponsors & Collaborators

• EQRx International, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-14

Primary Completion

2023-08-31

Completion

2023-08-31

FDA Drug

Yes

Countries

• United States

Study Locations