A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC) (COMPEL)

A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC) (COMPEL)

Brief Summary:
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients who have progressed extracranially following first-line osimertinib treatment.

Detailed Description:
This is a Phase III, randomized, double-blind, placebo-controlled study of platinum plus pemetrexed chemotherapy plus osimertinib versus platinum plus pemetrexed chemotherapy plus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm), metastatic NSCLC who responded to first-line osimertinib therapy and subsequently experienced radiological, extracranial disease progression. Approximately 204 patients will be randomized in a 1:1 ratio to treatment with platinum plus pemetrexed chemotherapy plus osimertinib (Treatment Arm A) or platinum plus pemetrexed chemotherapy plus placebo (Treatment Arm B). Patients will be stratified based on the presence of brain metastases (stable brain metastases based on central nervous system (CNS) Response Evaluation Criteria in Solid Tumors, Version 1.1 [RECIST 1.1] assessments versus no brain metastases).

The 2 randomized treatment regimens are as follows:
- Treatment Arm A: Osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m²) (with pre-treatment) plus either cisplatin (75 mg/m²) or carboplatin (area under the concentration-time curve [AUC] 5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m²) on Day 1 of 21-day cycles
- Treatment Arm B: Placebo QD with pemetrexed (500 mg/m²) (with pre-treatment) plus either cisplatin (75 mg/m²) or carboplatin (AUC5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m²) on Day 1 of 21-day cycles.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The patient, the Investigator, and the study site staff will be blinded to the study drug or placebo allocation. Patients may participate in the open label part of trial at the discretion of the investigator to receive osimertinib and continue any ongoing chemotherapy if intracranial progression is their first progression event.
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients With EGFRm, Locally Advanced or Metastatic NSCLC Who Have Progressed Extracranially Following First-Line Osimertinib Therapy (COMPEL)
Estimated Study Start Date: May 31, 2021
Estimated Primary Completion Date: July 15, 2024
Estimated Study Completion Date: December 30, 2024

Arm:
- Experimental: Treatment Arm A
- Experimental: Treatment Arm B

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