NCT05800587 Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
| NCT ID | NCT05800587 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fox Chase Cancer Center |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2028-08-01 |
Trial Parameters
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Brief Summary
This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities.
Eligibility Criteria
Inclusion Criteria: * Must have histologically or cytologically confirmed stage IV (AJCC version 8) lung cancer (small cell or non-small cell). Patients with stage III disease who are not felt to be candidates for definitive therapy are also eligible. * Must fit into at least one of the subgroups of patients as defined in section 3.3. * Patients must have planned therapy with a regimen that includes at least one cytotoxic agent as listed in Table 1 (e.g. platinum, taxane, anti-metabolite, vinca alkaloid, podophylotoxin, camptothecin, lurbinectidin etc). * Must have measurable disease as per RECIST criteria 1.1. * History of treated or untreated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria: * No ongoing requirement for corticosteroids as therapy for CNS disease * No stereotactic radiation or whole-brain radiation within 7 days prior to treatment initiation * Stable doses of anti-seizure medications are allowed if CNS disease has been treated
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