Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
A Biomarker-directed Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy.
Sponsor: AstraZeneca
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective response rate (ORR)
Time frame: Measured from first dose until confirmed response or progression. For each patient this is expected to be 3 months on average
Secondary Endpoints
Progression-free survival (PFS)
Duration of response (DoR)
Overall survival (OS)
Eligibility Criteria
Inclusion criteria applicable to all study treatment modules (Group A \& B) 1. NSCLC with the following features: 1. Locally advanced or metastatic disease (ie, advanced NSCLC) not amenable to curative surgery or radiotherapy at study entry. 2. Histologically or cytologically confirmed adenocarcinoma of the lung (patients with mixed histology are eligible if adenocarcinoma is the predominant histology) harboring EGFR mutation(s) known to be associated with EGFR TKI sensitivity at diagnosis. Any histologically identifiable component of neuroendocrine transformation to SCLC or large cell NEC is required for treatment under Module 7. 3. Received only one line of therapy, with single-agent osimertinib, for advanced NSCLC, with clinical benefit as judged by investigator discretion. (Note: a 'line' of therapy is defined as a daily anti-cancer treatment administered for \>14 days, or a single infusion of an intravenous anti-cancer treatment. For instance, patients who have h…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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