Non-Small Cell Lung Cancer
Conditions
Keywords
Non small cell lung cancer, neoadjuvant, EGFR-TKI
Brief summary
This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer
Interventions
DRUGOsimertinib
80mg/qd oral for 60 days
DRUGCisplatin
Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.
DRUGPemetrexed
Pemetrexed (500 mg/m2) to be administered with cisplatin on Day 1 of every 3-week cycle for 2 cycles
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
osimertinib plus chemotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete lymph node clearance rate | From date of enrollment to an average of 12 weeks after the first dose | the ratio of ypN0 percentage after resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response (MPR) | From date of enrollment to an average of 12 weeks after the first dose | Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery |
| Pathological complete response (pCR) | From date of enrollment to an average of 12 weeks after the first dose | Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery |
| Downstaging | From date of enrollment to an average of 12 weeks after the first dose | Measured using pathologic mediastinal lymph node evaluation |
| Disease free survival (DFS) | From date of enrollment up to approximately 42 months after date of resection | DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first. |
Countries
China
Contacts
Primary ContactHong Yang, Ph.D.,M.D.
Backup ContactJiyang Chen, Ph.D.,M.D.
Outcome results
None listed