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Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC (NOCE01)

Primary Purpose

Non-Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Osimertinib

Cisplatin

Pemetrexed

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non small cell lung cancer, neoadjuvant, EGFR-TKI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

osimertinib plus chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

complete lymph node clearance rate

the ratio of ypN0 percentage after resection

Secondary Outcome Measures

Major Pathological Response (MPR)

Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery

Pathological complete response (pCR)

Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery

Downstaging

Measured using pathologic mediastinal lymph node evaluation

Disease free survival (DFS)

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.

Full Information

NCT ID

NCT05011487

First Posted

August 15, 2021

Last Updated

November 11, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05011487

Brief Title

Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

Acronym

NOCE01

Official Title

Neoadjuvant Osimertinib Plus Chemotherapy for EGFR-mutant Stage III N2 Non-squamous Non-small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 13, 2021 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

Non small cell lung cancer, neoadjuvant, EGFR-TKI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

osimertinib plus chemotherapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

osimertinib plus chemotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Osimertinib

Other Intervention Name(s)

AZD9291, TAGRISSO

Intervention Description

80mg/qd oral for 60 days

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

DDP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

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

Primary Outcome Measure Information:

Title

complete lymph node clearance rate

Description

the ratio of ypN0 percentage after resection

Time Frame

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

Secondary Outcome Measure Information:

Title

Major Pathological Response (MPR)

Description

Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery

Time Frame

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

Title

Pathological complete response (pCR)

Description

Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery

Time Frame

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

Title

Downstaging

Description

Measured using pathologic mediastinal lymph node evaluation

Time Frame

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

Title

Disease free survival (DFS)

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

13560405144

Ext

13560405144

yanghong@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

008618826238208

chenjy1@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

008613560405144

yanghong@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

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