Combining osimertinib with chemotherapy for lung cancer treatment
Neoadjuvant Osimertinib Plus Chemotherapy for EGFR-mutant Stage III N2 Non-squamous Non-small Cell Lung Cancer
This study is testing if combining a targeted lung cancer drug called osimertinib with chemotherapy can help people with specific EGFR mutations have better surgery results and improve their overall health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, osimertinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05011487 on ClinicalTrials.gov |
What this trial studies
This phase II, single-arm, multi-center study evaluates the effectiveness of neoadjuvant osimertinib in combination with chemotherapy for patients with resectable EGFR-mutant stage III non-small cell lung cancer (NSCLC). The study aims to determine if this combination can improve surgical outcomes and overall patient prognosis. Participants will receive osimertinib along with cisplatin and pemetrexed before surgery. The study focuses on patients with specific EGFR mutations that are known to respond to targeted therapies.
Who should consider this trial
Good fit: Ideal candidates are patients with resectable EGFR-mutant stage III non-squamous NSCLC who are in good health and can undergo surgery.
Not a fit: Patients with a history of interstitial lung disease or those whose tumors do not harbor the specified EGFR mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes and improve survival rates for patients with advanced lung cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy in lung cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically documented N2 positive non-squamous NSCLC with resectable (Stage IIIA or T3-4N2 IIIB) disease (according to Version 8 of the IASLC Cancer Staging Manual \[IASLC Staging Manual in Thoracic Oncology 2016\]). * Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures). * Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing * A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q). Exclusion Criteria: * Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. * History of another primary malignancy, except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease * Patients who have pre-operative radiotherapy treatment as part of their care plan * Mixed small cell and NSCLC histology * T4 tumours infiltrating the aorta, the oesophagus and/or the heart; and/or any bulky N2 disease deemed unresectable * Patients who are candidates to undergo only segmentectomies or wedge resections * Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug * Prior treatment with EGFR-TKI therapy * Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hong Yang, Ph.D.,M.D. — Sun Yat-sen University
- Study coordinator: Hong Yang, Ph.D.,M.D.
- Email: yanghong@sysucc.org.cn
- Phone: 13560405144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.