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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 : November 12, 2021
Sponsor:
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

Tracking Information
First Submitted Date  ICMJE January 10, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date November 12, 2021
Actual Study Start Date  ICMJE January 29, 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensified Chemo-immuno-radiotherapy With Durvalumab for Stage III Non-Small Cell Lung Cancers
Official Title  ICMJE 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)
Brief Summary This is a phase II study that will assess if Durvalumab (MEDI4736) used as induction chemo-immunotherapy followed by concurrent chemo-immuno-radiotherapy and consolidation immunotherapy may improve oncologic outcomes compared with standard of care chemoradiation followed by durvalumab (as in the PACIFIC trial) with a reasonable safety profile.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective single-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Neoplasms
Intervention  ICMJE Drug: Durvalumab
Intensified chemo-immuno-radiotherapy with durvalumab in combination with carboplatin, paclitaxel and radiation
Other Names:
  • Carboplatin
  • Paclitaxel
Study Arms  ICMJE 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.

Concurrent chemo-immuno-radiotherapy:

Durvalumab 1500 mg intravenously every 28 days (+/- 7 days) for a maximum of 12 doses

Intervention: Drug: Durvalumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2020)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  1. Histologically or cytologically confirmed non-small cell lung cancer.
  2. Stage III according to the American Joint Committee on Cancer (AJCC) Staging Manual, 8th edition.
  3. No prior systemic therapy, radiation therapy, or surgery for the current cancer.
  4. Age ≥ 18 years at time of study entry
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Body weight >30kg
  7. Pre- or post-bronchodilator forced expiratory volume 1 ≥ 1.2 litres/second or ≥ 50% of predicted value
  8. Adequate normal organ and marrow function

EXCLUSION CRITERIA

  1. Patients whose radiation treatment is likely to encompass a volume of whole lung receiving ≥ 20 Gy in total of more than 35% of lung volume.
  2. Patients whose radiation treatment is likely to deliver a cardiac dose V50 > 25%
  3. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
  4. Participation in another clinical study with an investigational product with anti-neoplastic activity during the last 3 weeks prior to treatment initiation
  5. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  6. History of allogenic organ transplantation.
  7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  8. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
  9. Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
  10. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 antibodies
  11. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
  12. Prior radiation therapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  13. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of the investigational product.
  14. Active or prior documented autoimmune or inflammatory disorders
  15. Uncontrolled intercurrent illness
  16. History of another primary malignancy
  17. Known active infection including tuberculosis , hepatitis B, hepatitis C, or human immunodeficiency virus.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gustavo Werutsky +55 51 3384 5334 gustavo.werutsky@lacogcancerresearch.org
Contact: Laura Voelcker +55 51 3384 5334 laura.voelcker@lacogcancerresearch.org
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04230408
Other Study ID Numbers  ICMJE LACOG 2218
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Latin American Cooperative Oncology Group
Study Sponsor  ICMJE Latin American Cooperative Oncology Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Latin American Cooperative Oncology Group
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP