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Recruiting Phase 2 NCT05358548

ATATcH Alternating Treatment Plans for Advanced Cancer

Trial Parameters

Condition Head and Neck Cancer
Sponsor Rutgers, The State University of New Jersey
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-04-28
Completion 2025-05-01
Interventions
PaclitaxelPemetrexed5Fluorouracil

Brief Summary

The purpose of the research is to evaluate a new schedule of alternating cycles of induction chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab) alone for the initial treatment of patients with advanced lung or head and neck cancers.

Eligibility Criteria

Lung Cancer (Arms 1 and 2) * Patients must have histologically or cytologically confirmed stage IV NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition). Patients with Stage IIIB and IIIC disease are eligible if they are not candidates for combined chemotherapy and radiation; such cases should be discussed in a multidisciplinary tumor board. * Eligible NSCLC tissue histologies will include squamous cell carcinoma (enrolled and treated in Arm 1), and nonsquamous histologies (e.g. adenocarcinoma, large cell carincoma, etc.; enrolled and treated in Arm 2). Patients with mixed squamous, e.g., adenosquamous, histology will be enrolled and treated on Study Arm 1. Patients with any evidence of Small Cell Carcinoma will be excluded from study participation. * Patients may have ANY PD-L1 expression Tumor Proportion Score (TPS) status. Tissue testing for PD-L1 is strongly recommended. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patient may still

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