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This phase 2 study is designed to evaluate the safety and activity of TH-4000 a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC.
Full description
A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy.
Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.
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Key Eligibility Criteria:
Key Exclusion Criteria:
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Interventional model
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21 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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