Afatinib in pretreated patients with advanced NSCLC harbouring HER2 exon 20 mutations

Phase 2

Completed

Conditions: 10029107
advanced non-small cell lung cancer
10038666

Registration Number: NL-OMON42560

Lead Sponsor: European Thoracic Oncology Platform (ETOP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

• Histologically or cytologically confirmed, non-predominant squamous subtype, stage IIIB (non amenable to curative-intent multimodal treatment) or IV NSCLC, according to 7th TNM classification
• Tumour is platinum-refractory
• Measurable or evaluable disease (according to RECIST 1.1 criteria)
• Locally documented HER2 mutation
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Life expectancy >3 months
• Adequate haematological, renal and hepatic function
• Effective contraception, no pregnancy

Exclusion Criteria

• Mixed small-cell and non-small-cell histologic features
• Uncontrolled lepto-meningeal metastatic disease
• Previous treatment with HER2 targeted antibody or tyrosine kinase inhibitor
• Any previous (in the past 3 years) or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast
• History or presence of clinically relevant cardiovascular abnormalities
• Other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient*s capacity to participate in the trial
• Interstitial lung disease or pulmonary fibrosis
• Any concurrent systemic anticancer therapy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease control defined as complete or partial response, or disease<br /><br>stabilisation lasting at least 12 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Progression-free survival (time from the date of enrolment until documented<br /><br>progression or death, if progression is not documented) determined by RECIST 1.1<br /><br>- Objective response (best overall response across all assessment time-points<br /><br>from enrolment to termination of trial treatment) determined by RECIST 1.1<br /><br>- Overall survival (time from the date of enrolment until death from any cause)<br /><br>- Adverse events graded according to CTCAE V4.0.</p><br>