Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04364048|
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : July 8, 2020
Single arm study of induction durvalumab (1500 mg IV) for 1 cycle (every 4 weeks), administered prior to starting concurrent definitive chemoradiation, followed by consolidation durvalumab (1500 mg IV every 4 weeks) for up to 12 cycles.
The study will include an initial safety run-in portion. Patients in the safety run-in will be monitored through completion of induction durvalumab, chemoradiation, and 2 cycles of consolidation durvalumab for assessment of safety prior to completion of enrollment.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Non-small Cell Carcinoma||Drug: Induction Durvalumab Drug: Chemotherapy Radiation: Radiation Drug: Consolidation durvalumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction Durvalumab Followed by Chemoradiation and Consolidation Durvalumab (MEDI4736) for Stage III Non-small Cell Lung Cancer|
|Actual Study Start Date :||June 18, 2020|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Induction durvalumab, chemoradiation, consolidation durvalumab
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Drug: Induction Durvalumab
Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
Other Name: IMFINZI
Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
Drug: Consolidation durvalumab
Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
Other Name: IMFINZI
- Progression Free Survival (PFS) [ Time Frame: 12 months ]12-month progression-free survival will be measured using imaging after completion of chemoradiation, prior to C1 consolidation durvalumab (1-42 days after completion of chemoradiation). This will be compared with PACIFIC trial 12-month progression-free survival as historical control.
- Assess the frequency and severity of adverse events [ Time Frame: 12 months ]Toxicity will be measured by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.
- Objective Response Rate (ORR) [ Time Frame: 12 months ]ORR will be measured using two timepoints, per RECIST 1.1. "ORR1" will be assessed using baseline imaging in comparison to imaging obtained after completion of induction durvalumab and chemoradiation. "ORR2" will be assessed using imaging after completion of induction durvalumab and chemoradiation in comparison to imaging obtained while receiving, and after completion of, consolidation durvalumab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364048
|Contact: Rachel Sanborn, MDfirstname.lastname@example.org|
|Contact: Robyn Lillie, RN||3176345842 ext email@example.com|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Rachel Sanborn, MD||Providence Cancer Institute|