Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy … (NCT04585490) | Clinical Trial Compass
RecruitingPhase 3
Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC
United States48 participantsStarted 2021-08-25
Plain-language summary
The purpose of this study is to test whether or not number of circulating cancer cells detected in the blood can be decreased the by combining the standard treatment (durvalumab) with Tremelimumab and additional chemotherapy
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically- or cytologically-documented NSCLC presenting with locally-advanced, unresectable stage III disease (Version 8 of AJCC Staging Manual) or NSCLC with locoregional recurrence after previous definitive treatment.
✓. For stage III or recurrent disease, must have completed platinum-based chemotherapy and radiation therapy to all known tumor sites (60 Gy +/- 10%). Must not have known progression of disease.
✓. Must be receiving consolidation durvalumab following completion of radiation and chemotherapy, and less than 32 weeks has elapsed from their first dose of durvalumab. (Patients may sign consent for study before start of durvalumab, but confirm eligibility and enroll only after first dose of durvalumab is received).
✓. Able to potentially receive further consolidation chemotherapy plus durvalumab and tremelimumab, but not be currently intended to receive additional systemic consolidation chemotherapy apart from this durvalumab.
✓. Pre-treatment tumor tissue or tumor DNA sample is believed to be available for analysis
✓. Aged 18 years or older
✓. Weight \> 30kg
✓. Life expectancy ≥ 12 weeks
Exclusion criteria
✕. Vitiligo or alopecia
✕. Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
✕. Chronic skin condition not requiring systemic therapy