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Chemotherapy + Osimertinib for Non-Small Cell Lung Cancer (COMPEL Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling criteria at screening.
World Health Organization performance status of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization through post progression survival follow-up (up to approximately 3 years)
Awards & highlights

COMPEL Trial Summary

This trial will compare the efficacy of two types of chemotherapy treatments in patients who have progressed after taking osimertinib as their first line of treatment.

Who is the study for?
This trial is for adults with advanced or metastatic non-squamous NSCLC who've seen their cancer progress after first-line osimertinib treatment. They should be in good physical condition, not planning to have surgery or radiotherapy, and willing to use effective contraception. People can't join if they've had certain treatments recently, have heart rhythm problems, severe diseases, another active cancer within 2 years, lung conditions like ILD/pneumonitis, or can't absorb the drug well.Check my eligibility
What is being tested?
The study tests if adding osimertinib to chemotherapy is better than adding a placebo (a substance with no therapeutic effect) for NSCLC patients whose disease progressed after initial osimertinib therapy. Participants will receive either the combination of chemotherapy plus osimertinib or chemotherapy plus placebo.See study design
What are the potential side effects?
Osimertinib may cause side effects such as diarrhea, rashes, dry skin; nail changes; mouth sores; reduced appetite; fatigue; cough and shortness of breath. Chemotherapy can lead to hair loss, nausea/vomiting, increased risk of infection due to low blood cell counts.

COMPEL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant and use effective birth control or cannot become pregnant.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer is advanced, cannot be cured with surgery or radiotherapy.
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My lung cancer is non-squamous and confirmed by a lab test.
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My cancer outside the brain worsened after initial improvement or stability with osimertinib treatment.
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I have at least one cancer lesion that has not been treated with radiation.

COMPEL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization through post progression survival follow-up (up to approximately 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization through post progression survival follow-up (up to approximately 3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival(PFS):time from randomization until progression(intra- or extracranial whichever occurs first)per RECIST 1.1(for extracranial)and CNS RECIST 1.1(for intracranial progression)as assessed by Investigator or death due to any cause
Secondary outcome measures
Extracranial PFS is defined as time from randomization until extracranial progression per RECIST 1.1 as assessed by the Investigator at local site or death due to any cause
Intracranial PFS is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause
Number of patients with serious and non-serious adverse events
+1 more

COMPEL Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm AExperimental Treatment1 Intervention
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
Group II: Treatment Arm BPlacebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
303 Previous Clinical Trials
100,729 Total Patients Enrolled
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,689 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Research Study Groups: Treatment Arm B, Treatment Arm A
Non-Small Cell Lung Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT04765059 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What chemotherapy drugs has the FDA cleared Osimertinib (AZD9291) for use with?

"Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin has received a safety rating of 3. This is based off of the fact that this is a Phase 3 trial, which suggests that there is some evidence for efficacy and multiple rounds of data supporting safety."

Answered by AI

Is this research project actively recruiting new participants?

"The trial is still open for recruitment, as seen on clinicaltrials.gov. This specific study was originally posted on September 12th, 2021 and was edited on October 10th, 2022."

Answered by AI

Are there other ongoing studies that are testing Osimertinib (AZD9291) in combination with pemetrexed, cisplatin or carboplatin?

"The original trial for Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin was at City of Hope Comprehensive Cancer Center in 1997. As of now, there have been a total of 1790 completed trials and 1306 active trials. Many of these active trials are being conducted in Boston, Minnesota."

Answered by AI

How many participants are being included in this clinical trial?

"That is accurate. The clinical trial in question, which is looking for 204 participants at 4 locations, is actively recruiting patients according to the information available on clinicaltrials.gov. The trial was originally posted on September 12th, 2021 and was last edited on October 10th, 2022."

Answered by AI

Does this experimental treatment only test on geriatric patients?

"According to the inclusion criteria posted for this clinical trial, eligible patients must be between 18 and 130 years old. There are 143 trials for patients under the age of 18 and 3206 for people over 65."

Answered by AI

If I want to participate in this clinical trial, how many different city locations do I have to choose from?

"Currently, there are 4 enrolling sites for this study with more to come. The sites are situated in cities including Boston, Minneapolis and Silver Spring. If you enroll in the study, it is best to choose the clinic that is most convenient for you to reduce travel time and effort."

Answered by AI

What type of cancer do doctors most often treat with Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin?

"Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin is most often used to treat lymphoma, non-hodgkin. However, it has also shown efficacy in the treatment of malignant neoplasms, advanced sarcoma, and neoplasm metastasis."

Answered by AI

Might I be eligible to join this clinical trial?

"This study is for people with lung cancer who are 18 to 130 years old. There are 204 spots in the trial. To join, participants must: - Be male and willing to use contraception- Have a life expectancy of more than 12 weeks- Have stage IIIB or IIIC cancer that can't be cured with surgery or stage IVA or IVB cancer that has come back- Be in good enough health that they can take part in the trial- Be female and using contraception or not be able to have children"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
2021. "A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04765059.
~20 spots leftby Dec 2024
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