Iressa RE-challenge in advanced NSCLC EGFR mutated patients who responded to an EGFR-TKI used as first-line or previous treatment - NVALT 16.

Conditions: SCLCLung cancerEGFRTKI

Registration Number: NL-OMON28936

Lead Sponsor: VUmc

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 92

Inclusion Criteria

1. Histologically or cytologically confirmed NSCLC with an activating sensitising EGFR TK mutation as determined before starting the first EGFR-TKI treatment by using a well-validated and robust methodology;

2. Female or male patients aged 18 years or over with locally advanced or metastatic stage IIIB/IV disease, not suitable for therapy of curative intent or stage IV (metastatic) disease, eligible for gefitinib re-challenge treatment for NSCLC who have already received an EGFR-TKI with a documented complete (CR) or partial response (PR) or stable disease (SD) >12 weeks as the best response to their 1st EGFR-TKI treatment and who have received any subsequent anti-cancer therapy (excluding EGFR-TKIs) treatment, including but not limited to doublet platinum based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy, on which they progressed;

Exclusion Criteria

1. Known severe hypersensitivity to gefitinib or any of the excipients of the product;

2. Prior surgery or radiotherapy must be completed more than 6 months before start of study treatment. Palliative radiotherapy must be completed at least 4 weeks before start of study treatment with no persistent radiation toxicity. Previous adjuvant chemotherapy is allowed;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to evaluate the disease control rate (DCR; confirmed complete response (CR) or partial response (PR), or stable disease (SD)) of gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in patients with activating sensitising Epidermal Growth Factor mutation positive (EGFR M+) NSCLC.

Secondary Outcome Measures

Name	Time	Method
1. Objective response rate (ORR) according to RECIST;<br /><br>2. Progression free survival (PFS) according to RECIST;<br /><br>3. Overall Survival (OS);<br /><br>4. EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis. The EGFR mutational status will be compared with EGFR mutational status at diagnosis / before study entry: to this end archival tumour sample or archival tumour DNA sample will be collected;<br /><br>5. The association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed;<br /><br>6. mRNA in platelets will be analysed for its predictive value in response to targeted therapies;<br /><br>7. cfDNA in plasma and serum samples will be analysed on EGFR mutation status.

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