98 Participants Needed

Chemotherapy + Osimertinib for Non-Small Cell Lung Cancer

(COMPEL Trial)

Recruiting at 44 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: Osimertinib
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests a combination of chemotherapy and osimertinib in patients with advanced lung cancer that has spread outside the brain after earlier treatment. Osimertinib blocks a protein that helps cancer grow, and chemotherapy kills cancer cells. Osimertinib has shown improvements in progression-free survival over earlier treatments and is preferred for initial treatment of EGFR-mutant NSCLC.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using medications or supplements that strongly affect a specific liver enzyme (CYP3A4). It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug combination of chemotherapy and osimertinib for non-small cell lung cancer?

Osimertinib has shown effectiveness in treating non-small cell lung cancer (NSCLC) with specific genetic mutations, significantly prolonging progression-free survival and demonstrating durable tumor response rates in clinical trials. It is particularly effective for patients with EGFR T790M mutation-positive NSCLC who have developed resistance to earlier treatments.12345

Is the combination of chemotherapy and osimertinib safe for humans?

Osimertinib, also known as Tagrisso, has been studied for safety in patients with non-small cell lung cancer. Common side effects include diarrhea, rash, dry skin, and nail issues, with some patients experiencing more severe side effects. It is generally well tolerated, but some patients may need to stop treatment due to side effects.12346

How does the drug combination of Chemotherapy and Osimertinib differ from other drugs for non-small cell lung cancer?

The combination of Chemotherapy and Osimertinib is unique because it pairs traditional chemotherapy, which kills rapidly dividing cancer cells, with Osimertinib, a targeted therapy that specifically inhibits a protein involved in cancer cell growth. This dual approach aims to enhance treatment effectiveness by attacking the cancer in two different ways.7891011

Eligibility Criteria

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.

Inclusion Criteria

I am not pregnant and use effective birth control or cannot become pregnant.
I am fully active or restricted in physically strenuous activity but can do light work.
My lung cancer is advanced, cannot be cured with surgery or radiotherapy.
See 6 more

Exclusion Criteria

I cannot take osimertinib due to severe nausea, vomiting, gut diseases, swallowing issues, or major bowel surgery.
I haven't had treatment for another cancer within the last 2 years.
I have not had major surgery in the last 4 weeks.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive platinum plus pemetrexed chemotherapy with either osimertinib or placebo for 4 cycles, followed by maintenance therapy

12 weeks
4 visits (in-person) for initial cycles, then maintenance visits every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years
Every 6 weeks for the first 13 cycles, then every 12 weeks

Treatment Details

Interventions

  • Chemotherapy
  • Osimertinib
Trial OverviewThe 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.
Participant Groups
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

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
🇺🇸
Approved in United States as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
🇨🇦
Approved in Canada as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
🇯🇵
Approved in Japan as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
🇨🇳
Approved in China as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
🇨🇭
Approved in Switzerland as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials
322
Recruited
137,000+
Peyton Howell profile image

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Findings from Research

Osimertinib (Tagrisso) is a targeted therapy approved by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) who have the EGFR T790M mutation and have progressed after previous treatments.
The drug received special designations from the FDA, including breakthrough therapy and priority review, highlighting its significance in treating resistant forms of NSCLC.
Targeting the Gatekeeper: Osimertinib in EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer.Skoulidis, F., Papadimitrakopoulou, VA.[2022]
Osimertinib significantly improves disease-free survival (DFS) in adults with completely resected, early-stage EGFR mutation-positive non-small cell lung cancer (NSCLC), as shown in the pivotal ADAURA trial, regardless of prior adjuvant chemotherapy.
The treatment is well tolerated with a manageable safety profile, and it does not negatively impact health-related quality of life, making it a suitable option for adjuvant therapy in this patient population.
Osimertinib: A Review in Completely Resected, Early-Stage, EGFR Mutation-Positive NSCLC.Frampton, JE.[2022]
Osimertinib is an oral medication specifically designed to target the EGFR T790M mutation in advanced non-small cell lung cancer (NSCLC), which helps overcome resistance to previous EGFR TKI therapies.
It received accelerated approval in the USA in November 2015 for patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed after EGFR TKI treatment, and is currently undergoing further development for broader treatment applications.
Osimertinib: First Global Approval.Greig, SL.[2022]

References

Targeting the Gatekeeper: Osimertinib in EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer. [2022]
Osimertinib: A Review in Completely Resected, Early-Stage, EGFR Mutation-Positive NSCLC. [2022]
Osimertinib: First Global Approval. [2022]
Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer. [2022]
Osimertinib as first-line therapy in advanced NSCLC: a profile of its use. [2020]
New Adjuvant Drug for Lung Cancer. [2023]
Three emerging new drugs for NSCLC: pemetrexed, bortezomib, and cetuximab. [2022]
Is there any impact of new drugs on the outcome of advanced NSCLC? An overview of the Southern Italy Cooperative Oncology Group trials. [2022]
Platinum drugs in the treatment of non-small-cell lung cancer. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
An update on European randomized studies in non-small cell lung cancer. [2007]
11.United Statespubmed.ncbi.nlm.nih.gov
Chemotherapy in metastatic non-small-cell lung cancer. [2022]