Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

NCT ID: NCT05011487

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-13
• Study Completion Date: 2028-09-30

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

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

osimertinib plus chemotherapy

Osimertinib (80mg/qd) po. for 60 days with two cycles of Pemetrexed (500 mg/m2) to be administered with cisplatin (75mg/m2) on Day 1 of every 3-week cycle for 2 cycles

Group Type: EXPERIMENTAL

Osimertinib

Intervention Type: DRUG

80mg/qd oral for 60 days

Cisplatin

Intervention Type: DRUG

Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.

Pemetrexed

Intervention Type: DRUG

Pemetrexed (500 mg/m2) to be administered with cisplatin on Day 1 of every 3-week cycle for 2 cycles

Interventions

Osimertinib

80mg/qd oral for 60 days

Intervention Type: DRUG

Cisplatin

Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.

Intervention Type: DRUG

Pemetrexed

Pemetrexed (500 mg/m2) to be administered with cisplatin on Day 1 of every 3-week cycle for 2 cycles

Intervention Type: DRUG

Other Intervention Names

AZD9291; TAGRISSO; DDP

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yang Hong

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Yang, Ph.D.,M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong Yang, Ph.D.,M.D.

Role: CONTACT

yanghong@sysucc.org.cn

13560405144 ext. 13560405144

Jiyang Chen, Ph.D.,M.D.

Role: CONTACT

chenjy1@sysucc.org.cn

008618826238208

Facility Contacts

Hong Yang, Ph.D.,M.D.

Role: primary

yanghong@sysucc.org.cn

008613560405144

Other Identifiers

SYSUCC B2021-167-01

Identifier Type: -

Identifier Source: org_study_id