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To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion

Primary Purpose

NRG1-fused Non-small Cell Lung Cancer

Status

Not yet recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Afatinib Dimaleate

About this trial

This is an interventional treatment trial for NRG1-fused Non-small Cell Lung Cancer focused on measuring Locally advanced (stage IIIB) or metastatic (stage IV), have previously received platinum-based doublet chemotherapy and developed disease progression subsequently

Eligibility Criteria

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

Inclusion Criteria:

The patient or his/her legal representative has signed a written informed consent form and dated it prior to any specific research procedure.
Aged 18 years or older.
Locally advanced or metastatic non-small cell lung cancer with NRG1 fusion detected by DNA or RNA-based next-generation sequencing (NGS) technology in tumor tissue specimens or liquid specimens.
The patient has received platinum-based doublet chemotherapy previously.
ECOG performance status score is 0~2.
The patient has sufficient bone marrow and organ functionality, which can be proved by complete blood cell count, blood biochemistry and urine biochemistry tests at baseline.
The patient has measurable lesion(s).
The female patient of childbearing age must adopt appropriate contraceptive measures and are not allowed to breastfeed a child.
The male patient must voluntarily use contraceptives.

Exclusion Criteria:

The patient has shown any severe or uncontrollable systemic disease sign that the investigators believe may significantly change the risk/benefit balance of the patient, including uncontrollable hypertension, high active bleeding tendency, active infection or significant damage of bone marrow or other functions.
The patient has previously been treated with EGFR-TKI or any monoclonal antibody that acts on HER2/3.
The patient has been found with symptomatic metastatic tumor of central nervous system (CNS).
The patient has a history of interstitial pneumonia or radiation pneumonia requiring steroid therapy.
The patient has not recovered yet from toxic reactions with CTCAE grade ≥3 (CTCAE5.0) caused by previous treatment.

Sites / Locations

Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Afatinib treatment group

Arm Description

This is an open-label, sing-arm phase IV clinical study

Outcomes

Primary Outcome Measures

objective response rate (ORR)

ORR

Secondary Outcome Measures

disease control rate (DCR)

DCR

progression-free survival (PFS)

PFS

Full Information

NCT ID

NCT04814056

First Posted

March 23, 2021

Last Updated

March 30, 2021

Sponsor

Shanghai Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04814056

Brief Title

To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion

Official Title

An Open-Labeled, Single-Arm Clinical Study to Evaluate the Efficacy of Afatinib in Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer With NRG1-Fusion

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2021 (Anticipated)

Primary Completion Date

September 29, 2023 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is an open-label, sing-arm, phase IV clinical study. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment.

Detailed Description

This is an open-label, sing-arm clinical study,which will recruit about 15 patients in China. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment. Target Patient Population:Locally advanced (stage IIIB) or metastatic (stage IV) NRG1-fused non-small cell lung cancer patients, who have previously received platinum-based doublet chemotherapy and developed disease progression subsequently. Test Drug, Dosage and Medication Regimen:Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D. Evaluations of Study:The data to be collected include demographic characteristics of the patients, information necessary to determine whether the patients are qualified (including medical history, features of previous and current diseases and NRG1 fusion status in tumor tissue), and efficacy and safety data in terms of objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).

6. Conditions and Keywords

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

NRG1-fused Non-small Cell Lung Cancer

Keywords

Locally advanced (stage IIIB) or metastatic (stage IV), have previously received platinum-based doublet chemotherapy and developed disease progression subsequently

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Afatinib treatment group

Arm Type

Experimental

Arm Description

This is an open-label, sing-arm phase IV clinical study

Intervention Type

Drug

Intervention Name(s)

Afatinib Dimaleate

Other Intervention Name(s)

GIOTRIF®

Intervention Description

Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D.

Primary Outcome Measure Information:

Title

objective response rate (ORR)

Description

ORR

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

disease control rate (DCR)

Description

DCR

Time Frame

Up to 12 months

Title

progression-free survival (PFS)

Description

PFS

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient or his/her legal representative has signed a written informed consent form and dated it prior to any specific research procedure. Aged 18 years or older. Locally advanced or metastatic non-small cell lung cancer with NRG1 fusion detected by DNA or RNA-based next-generation sequencing (NGS) technology in tumor tissue specimens or liquid specimens. The patient has received platinum-based doublet chemotherapy previously. ECOG performance status score is 0~2. The patient has sufficient bone marrow and organ functionality, which can be proved by complete blood cell count, blood biochemistry and urine biochemistry tests at baseline. The patient has measurable lesion(s). The female patient of childbearing age must adopt appropriate contraceptive measures and are not allowed to breastfeed a child. The male patient must voluntarily use contraceptives. Exclusion Criteria: The patient has shown any severe or uncontrollable systemic disease sign that the investigators believe may significantly change the risk/benefit balance of the patient, including uncontrollable hypertension, high active bleeding tendency, active infection or significant damage of bone marrow or other functions. The patient has previously been treated with EGFR-TKI or any monoclonal antibody that acts on HER2/3. The patient has been found with symptomatic metastatic tumor of central nervous system (CNS). The patient has a history of interstitial pneumonia or radiation pneumonia requiring steroid therapy. The patient has not recovered yet from toxic reactions with CTCAE grade ≥3 (CTCAE5.0) caused by previous treatment.

Central Contact Person:

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

Yongfeng Yu, Master

Phone

18017321559

yuyongfeng212@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongfeng Yu, Master

Organizational Affiliation

Shanghai Chest Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai Chest Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yongfeng Yu, Master

Phone

18017321559

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion

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