Clinical trial NCT05011487: Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC
Official title: Neoadjuvant Osimertinib Plus Chemotherapy for EGFR-mutant Stage III N2 Non-squamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Non small cell lung cancer
neoadjuvant
EGFR-TKI
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: osimertinib plus chemotherapy
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: complete lymph node clearance rate
timeFrame: From date of enrollment to an average of 12 weeks after the first dose
Secondary outcomes:
measure: Major Pathological Response (MPR)
timeFrame: From date of enrollment to an average of 12 weeks after the first dose
measure: Pathological complete response (pCR)
timeFrame: From date of enrollment to an average of 12 weeks after the first dose
measure: Downstaging
timeFrame: From date of enrollment to an average of 12 weeks after the first dose
measure: Disease free survival (DFS)
timeFrame: From date of enrollment up to approximately 42 months after date of resection
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hong Yang, Ph.D.,M.D.
role: PRINCIPAL_INVESTIGATOR
References: