Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer

Summary

This is a randomized, double-blinded, placebo-controlled Phase 3 clinical trial to compare the combination of lerociclib (administered at 150 mg twice a day (BID) with letrozole (administered at 2.5 mg once a day (QD) to that of placebo with letrozole (2.5 mg QD) in female participants with Grade 1 or Grade 2 (ie, low-grade histology) endometrioid endometrial cancer (EC) and advanced/metastatic or recurrent disease.

The study population will consist of female participants with endometrioid EC who are treatment-naïve in the advanced/metastatic setting (ie, the first-line \[1L\] population). Participants may have received prior adjuvant chemotherapy/chemoradiation for localized disease if the adjuvant therapy was administered ≥ 6 months prior. All participants must also be naïve to prior endocrine therapy for EC, and confirmed as medically postmenopausal to be eligible.

The study will comprise a Screening Period of up to 28 days in duration; a Study Treatment Phase; a Safety Follow-up Period spanning the time of study treatment discontinuation-including discontinuation due to confirmed disease progression, as applicable-through 28 days after the participant's last dose of any study intervention or the start of subsequent anticancer therapy (whichever occurs first); and a Survival Follow-up Period that will continue until the participant's death or until at least 50% of all study participants have died (whichever occurs first).

While receiving their randomized assigned study treatment, participants will undergo imaging assessments via computed tomography (CT) of the chest/abdomen/pelvis with contrast- or, if CT is medically contraindicated (eg, due to iodine allergy), via magnetic resonance imaging (MRI) with gadolinium-every 8 weeks for the first 12 months and then every 12 weeks thereafter.

Conditions

• Endometrial Carcinoma

Interventions

DRUG

Lerociclib

All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted. Participants will be randomized to receive either lerociclib (administered at 150 mg twice a day (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD). Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata: * Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent) * EC tumor grade (Grade 1 versus Grade 2) * Geographic location (US versus Europe versus Rest of World)

DRUG

Letrozole 2.5mg

All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted. Participants will be randomized to receive either lerociclib (administered at 150 mg twice daily (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD). Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata: * Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent) * EC tumor grade (Grade 1 versus Grade 2) * Geographic location (US versus Europe versus Rest of World)

DRUG

Placebo

All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted. Participants will be randomized to receive either lerociclib (administered at 150 mg twice day (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD). Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata: * Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent) * EC tumor grade (Grade 1 versus Grade 2) * Geographic location (US versus Europe versus Rest of World)

Sponsors & Collaborators

• GOG Foundation

  collaborator NETWORK

• European Network of Gynaecological Oncological Trial Groups (ENGOT)

  collaborator OTHER

• EQRx International, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-18

Primary Completion

2024-03-31

Completion

2025-03-31

FDA Drug

Yes