Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

NCT05011487 | Recruiting Phase 2 DMC

• 1 other identifier: SYSUCC B2021-167-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Non small cell lung cancer; neoadjuvant; EGFR-TKI

Outcome Measures

Primary Outcomes (1)

• complete lymph node clearance rate

  the ratio of ypN0 percentage after resection

  From date of enrollment to an average of 12 weeks after the first dose

Secondary Outcomes (4)

• Major Pathological Response (MPR)

  From date of enrollment to an average of 12 weeks after the first dose

• Pathological complete response (pCR)

  From date of enrollment to an average of 12 weeks after the first dose

• Downstaging

  From date of enrollment to an average of 12 weeks after the first dose

• Disease free survival (DFS)

  From date of enrollment up to approximately 42 months after date of resection

Study Arms (1)

osimertinib plus chemotherapy

EXPERIMENTAL

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

Drug: Osimertinib; Drug: Cisplatin; Drug: Pemetrexed

Interventions

Osimertinib DRUG

80mg/qd oral for 60 days

Also known as: AZD9291, TAGRISSO

osimertinib plus chemotherapy

Cisplatin DRUG

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

Also known as: DDP

osimertinib plus chemotherapy

Pemetrexed DRUG

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

osimertinib plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Hong Yang, Ph.D.,M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

13560405144; yanghong@sysucc.org.cn

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

CONTACT

008618826238208; chenjy1@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: osimertinib plus chemotherapy

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 18, 2021
• Study Start: August 13, 2021
• Primary Completion: September 1, 2023
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CN (1)