Osimertinib +/- Chemotherapy for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather information on the effectiveness and safety of the drug osimertinib, alone or with chemotherapy, for people with EGFR-mutated non-small cell lung cancer (NSCLC). Researchers seek to understand how these treatments perform in a real-world setting outside traditional clinical trials. The trial seeks individuals diagnosed with advanced NSCLC who have a specific EGFR mutation, even if they have received certain treatments before. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment option.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it allows prior chemotherapy or immunotherapy if it was given before the EGFR mutation was identified, and prior treatment with osimertinib is allowed within 30 days of registration.
What is the safety track record for these treatments?
In a previous study, patients taking osimertinib alone reported common side effects, such as diarrhea (47% of patients) and rash (46% of patients). More serious issues could include lung problems, which may be severe or even life-threatening. However, no specific conditions automatically prevent someone from taking osimertinib.
When combined with chemotherapy, all patients in one study experienced some side effects. This combination can lead to more severe side effects, but they are generally manageable and align with known effects of these treatments. Additionally, this combination significantly reduced the risk of death compared to using osimertinib alone.
Overall, whether used alone or with chemotherapy, osimertinib has been studied extensively, and its side effects are well-documented. While risks exist, the treatment is generally considered manageable for many patients.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for EGFR-mutated non-small cell lung cancer (NSCLC) because they offer a new approach to tackling the disease. Osimertinib, a targeted therapy, specifically inhibits the mutated EGFR protein, which is a common driver of tumor growth in these patients. Unlike traditional chemotherapy, which attacks rapidly dividing cells throughout the body, Osimertinib focuses directly on the cancer cells, potentially leading to fewer side effects. When combined with chemotherapy, the hope is to enhance the effectiveness of treatment by simultaneously targeting cancer cells in multiple ways, possibly improving outcomes for patients.
What evidence suggests that this trial's treatments could be effective for EGFR-mutant NSCLC?
Research has shown that osimertinib effectively treats EGFR-mutated non-small cell lung cancer (NSCLC). Studies found that patients taking osimertinib lived an average of 58.8 months, compared to 54.1 months for those on a placebo, demonstrating its benefits. In this trial, participants in Group 1 will receive osimertinib alone, while Group 2 will receive osimertinib combined with chemotherapy. This combination has improved results further, reducing the risk of death by 23% compared to osimertinib alone, with patients living nearly four years on average. These findings suggest that osimertinib, especially when combined with chemotherapy, can significantly extend the lives of patients with this type of lung cancer.678910
Who Is on the Research Team?
Suzanne Cole, MD
Principal Investigator
UT Southwestern Simmons Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care osimertinib with or without chemotherapy as determined by the treating physician
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chemotherapy
- Osimertinib
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Osimertinib + Chemotherapy
Osimertinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
PrECOG, LLC.
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Collaborator
Citations
Tagrisso plus chemotherapy demonstrated a median ...
Over the past decade, Tagrisso has consistently delivered strong survival benefits and tolerable safety across all stages of non-small cell lung ...
Overall Survival with Osimertinib in Resected EGFR ...
In the overall population (patients with stage IB to IIIA disease), the 5-year overall survival was 88% in the osimertinib group and 78% in the placebo group ( ...
Real-world efficacy of low dose osimertinib as second-line ...
Treatment with low dose osimertinib demonstrated good efficacy and tolerability in EGFR-mutated advanced NSCLC patients who failed first-line treatment.
4.
astrazeneca-us.com
astrazeneca-us.com/media/press-releases/2025/New-study-results-reinforce-TAGRISSO-osimertinib-as-the-backbone-therapy-for-EGFR-mutated-lung-cancer-across-stages-and-settings.htmlNew study results reinforce TAGRISSO® (osimertinib) as ...
Median OS was 58.8 months (95% CI 54.1, not calculable [NC]) in patients treated with TAGRISSO versus 54.1 months with placebo (95% CI 42.1, NC) ...
Brief Report: The Effectiveness of Osimertinib in Advanced ...
For osimertinib as second-line or beyond systemic treatment, the median OS was 36.6 months (95% CI, 23.4-49.8 months) in the E746del group, 64.5 months (95% CI, ...
SAFETY DATA SHEET
Wash hands after use. The product may form flammable dust clouds in air, if dust from crushed tablets is allowed to accumulate. Conditions for ...
Safety Profile of TAGRISSO® (osimertinib) for Metastatic ...
IMPORTANT SAFETY INFORMATION · There are no contraindications for TAGRISSO · TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.
TAGRISSO® (osimertinib) tablets, for oral use
In this pooled safety population, the most common adverse reactions in ≥20% of 1813 patients who received TAGRISSO monotherapy were diarrhea (47%), rash (46%), ...
TAGRISSO: Treatment for Certain Types of EGFR+ NSCLC
IMPORTANT SAFETY INFORMATION. TAGRISSO may cause serious side effects, including: Lung problems. TAGRISSO may cause severe lung problems that may lead to death.
Cardiac Safety of Osimertinib: A Review of Data - PMC
Osimertinib provided statistically significant superior median progression-free survival (PFS) and overall survival (OS) versus comparator EGFR-TKIs (erlotinib ...
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