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Phase II open-label gefitinib re-challenge in EGFR-mutant NSCLC (Italy)
2011-005157-31Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2012
- Countries
- 1
- Sponsor
- AstraZeneca
- Modality
- Small Molecules
- Drugs
- gefitinib
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label, single-arm trial of gefitinib in non-small cell lung cancer (NSCLC), sponsored by AstraZeneca. Started Mar 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Gefitinib (IRESSA) re-challenge
Participants receive oral gefitinib 250 mg once daily as monotherapy after prior clinical benefit from gefitinib and subsequent non-EGFR TKI anticancer therapy.
03
Who it enrols
Adults with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer who previously responded to gefitinib and subsequently received chemotherapy or other active anticancer therapy excluding EGFR tyrosine kinase inhibitors; patients with known severe hypersensitivity to gefitinib or its excipients are excluded.
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