A study to evaluate Chemotherapy Plus Osimertinib against Chemotherapy Plus Placebo in patients with non-small cell lung cancer (NSCLC) - COMPEL

Study identifier:D5162C00042

ClinicalTrials.gov identifier:NCT04765059

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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)

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin, Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin

Sex

All

Estimated Enrollment

204

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 12 Sept 2021

Estimated Primary Completion Date: 12 Jun 2024

Estimated Study Completion Date: 31 Dec 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2023 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

1) Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
2) Pathologically confirmed non-squamous NSCLC.
3) Locally advanced (clinical stage IIIB or IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC), not amenable to curative surgery or radiotherapy.
4) Evidence of radiological extracranial disease progression following response with first-line osimertinib treatment but who have not received further, subsequent treatment.
5) World Health Organization performance status of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks.
6) Life expectancy >12 weeks at Day 1.
7) At least 1 lesion, not previously irradiated.
8) Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling criteria at screening.
9) Male patients must be willing to use barrier contraception

Exclusion Criteria

1) Clinical or radiological evidence of CNS progression on first-line osimertinib.
2) Past medical history of ILD (interstitial lung disease)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis.
3) Any evidence of severe or uncontrolled extracranial diseases.
4) Any of the following cardiac criteria:
i) Mean resting QTc >470 msec
ii) Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram
iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
5) Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of investigational product (IP).
6) Any unresolved toxicities from prior extracranial therapy.
7) Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib.
8) More than 4 weeks elapsed since last dose of osimertinib by date of randomization.
9) Unable to tolerate osimertinib 80 mg first-line therapy.
10) Prior treatment with any systemic anti-cancer therapy.
11) Major surgery within 4 weeks of the first dose of IP.
12) Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP.
13) Current use of medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4.
14) Participation in another clinical study with an IP other than first-line osimertinib.

Sort by status

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Arms	Assigned Interventions
Experimental: Treatment Arm A All randomized patients will receive osimertinib 80 mg QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin ([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/m^2) on Day 1 of 21-day cycles	Drug: Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin Randomized patients will receive oral dose of osimertinib with intravenous (IV) pemetrexed plus either IV cisplatin or IV carboplatin
Placebo Comparator: Treatment Arm B All randomized patients will receive placebo QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin (AUC5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles	Drug: Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin Randomized patients will receive oral dose of placebo matching osimertinib with IV pemetrexed plus either IV cisplatin or IV carboplatin

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]