Afatinib in NSCLC With HER2 Mutation

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: afatinib; Drug: paclitaxel

• Registration Number: NCT02597946
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2 mutations, previously treated with 1 or 2 chemotherapy regimens

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Study Start: 2016-03-18
• Primary Completion: 2018-07-22
• Study Completion: 2018-07-22
• Results First Submitted: 2019-07-15
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Results First Posted: 2019-10-01
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all patients	paclitaxel	Part A: all enrolled patients will receive afatinib monotherapy. Part B: all eligible patients will receive afatinib combined with weekly paclitaxel.
all patients	afatinib	Part A: all enrolled patients will receive afatinib monotherapy. Part B: all eligible patients will receive afatinib combined with weekly paclitaxel.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Objective Response (OR) in Part A According to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1	CT Scan at Weeks 8 & 12 (for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment , ie., up to approximately 12 Months	Percentage of patients with objective response (OR) in part A according to RECIST 1.1. Objective Response defined as patients with tumour size reduction of a predefined amount using RECIST 1.1 in part A. Objective response included both confirmed Partial Response (PR) plus Complete Response (CR) as measured by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) according to RECIST 1.1.; Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions asking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Disease Control (DC) in Part A	CT Scan at Weeks 8 & 12(for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment, ie up to approximately 12 Months	Percentage of patients with disease control (DC) in part A. Disease control defined as patients who have achieved confirmed complete response, partial response and stable disease as measured by CT scan or MRI according to RECIST 1.1 in part A.; Tumour Response is based on clinical, radiological or other assessment. Clopper-Pearson method used for confidence limits.; Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, taking as reference the baseline sum LD, nor sufficient increase to qualify for Progression (PD) taking as reference the smallest sum LD since the treatment started.
Progression Free Survival (PFS) in Part A	From the date of starting treatment of afatinib to the date of disease progression or to the date of death, ie up to approximately 12 Months	Progression Free Survival (PFS) defined as the time from the date of starting treatment of afatinib to the date of disease progression per RECIST 1.1, or to the date of death no matter which happens first in part A.; Median and 95% confidence interval (CI) are calculated from an unadjusted Kaplan-Meier curve.
Overall Survival (OS)	From start of treatment of afatinib until death from any cause, ie up to approximately 12 Months	Overall survival (OS) defined as the time from start of treatment of afatinib until death from any cause.; Median and 95% CI are calculated from an unadjusted Kaplan-Meier curve.
Time to Progression (TTP) in Part A	From the date of starting treatment of afatinib to the date of disease progression , ie up to approximately 12 Months	Time to progression (TTP) defined as the time from the date of starting treatment of afatinib to the date of disease progression per RECIST 1.1 in part A.; Median and 95% CI are calculated from an unadjusted Kaplan-Meier curve.
Duration of Response (DOR) in Part A	CT Scan at Weeks 8 & 12(for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment, ie up to approximately 12 Months	Duration of response (DoR) defined as the time from the first documented response PR or CR to the date of tumor progression evaluated according to RECIST 1.1 or death in part A.; Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions.; No patient had objective response and DoR was not analysed.

Trial Locations

Locations (9)

First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, China

The Second Affiliated Hospital to Nanchang University; 🇨🇳 Nanchang, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China

Hunan Province Tumor Hospital; 🇨🇳 Changsha, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

First Hospital Affiliated with Nanjing Medical University; 🇨🇳 Nanjing, China