Intensified Chemo-immuno-radiotherapy With Durvalumab for Stage III Non-Small Cell Lung Cancers (PACIFIC BRAZIL)
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|ClinicalTrials.gov Identifier: NCT04230408|
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : September 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Drug: Durvalumab||Phase 2|
Prospective, non-randomized, open label, single arm, multi-institutional, phase 2 study, including patients with stage III non-small cell lung cancer able to receive concurrent chemoradiation. Eligible patients will then receive treatment as follows:
Induction chemo-immunotherapy Two 21-day cycles of carboplatin, paclitaxel and durvalumab will be given BEFORE concurrent chemo-immuno-radiotherapy.
Thereafter, patients without progressive disease (or patients with disease progression that is still locally advanced and can be safely encompassed within tolerable radiation fields) will receive concurrent chemo-immuno-radiotherapy, as follows:
Concurrent chemo-immuno-radiotherapy Concurrent carboplatin, paclitaxel, and durvalumab with radiation therapy, initiated preferably 3-5 weeks after the last dose of induction chemo-immunotherapy.
Thereafter, patients without progressive disease will receive consolidation immunotherapy, as follows:
Consolidation immunotherapy Twelve 28-day cycles of durvalumab will be given, initiated preferably within one week following concurrent chemo-immuno-radiotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective single-arm study|
|Masking:||None (Open Label)|
|Official Title:||Intensified Chemo-immuno-radiotherapy With Durvalumab (MEDI4736) for Stage III Non-Small Cell Lung Cancers (NSCLCs): a Brazilian Single Arm Phase II Study (PACIFIC BRAZIL)|
|Actual Study Start Date :||January 29, 2021|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2024|
Experimental: DURVALUMAB (MEDI4736) + carboplatin-paclitaxel
Induction chemo-immunotherapy phase:
Two cycles of Paclitaxel 200 mg/m2, Carboplatin AUC 6 and Durvalumab 1500 mg intravenously every 21 days.
Concurrent chemo-immuno-radiotherapy phase:
Radiation therapy concomitantly with: paclitaxel 50 mg/m2 intravenously every 7 days (+/- 3 days) until completion of radiation therapy, carboplatin AUC 2 intravenously every 7 days (+/- 3 days) until completion of radiation therapy and durvalumab 1500 mg intravenously every 21 days (+/- 6 days) for a maximum of 2 doses.
Durvalumab 1500 mg intravenously every 28 days (+/- 7 days) for a maximum of 12 doses
Intensified chemo-immuno-radiotherapy with durvalumab in combination with carboplatin, paclitaxel and radiation
- 12 months Progression-Free Survival [ Time Frame: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation therapy. ]Proportion of patients who are alive and progression-free 12 months after cycle 1, day 1 of induction treatment, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Overall Survival (OS) [ Time Frame: OS will be evaluated until month 24 after C1D1. ]Time from cycle 1, day 1 of induction treatment until death due to any cause.
- Overall response rate to induction treatment [ Time Frame: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation therapy. ]The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1.
- Patterns of Failure [ Time Frame: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation therapy. ]Rate of disease failure in local, regional and distant sites
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): NCT04230408
|Contact: Gustavo Werutsky||+55 51 3384 email@example.com|
|Contact: Laura Voelcker||+55 51 3384 firstname.lastname@example.org|
|Liga Norte Riograndense Contra o Câncer||Not yet recruiting|
|Natal, Rio Grande Do Norte, Brazil, 59075-740|
|Contact: Danielli Matias, MD 55 84 4009 5595 email@example.com|
|Porto Alegre, Rio Grande Do Sul, Brazil|
|Contact: Gustavo Werutsky|
|Principal Investigator: Gustavo Werutsky|
|Rio De Janeiro, RJ, Brazil|
|Contact: Luiz Henrique de Lima Araújo|
|Instituto D'OR||Not yet recruiting|
|Rio De Janeiro, RJ, Brazil|
|Contact: Clarissa Baldotto|
|Principal Investigator: Clarissa Baldotto, MD|
|COI Américas||Not yet recruiting|
|Rio De Janeiro, Brazil|
|Contact: Luiz Henrique de Lima Araujo|
|Principal Investigator: Luiz Henrique de Lima Araujo|
|Beneficiencia Portuguesa de São Paulo/Hospital São José||Recruiting|
|São Paulo, Brazil|
|Contact: William William|
|Principal Investigator: William William, MD|
|ICESP||Not yet recruiting|
|São Paulo, Brazil|
|Contact: Gilberto Castro, MD|
|Principal Investigator: Gilberto Castro, MD|