CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04062708|
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer||Drug: Durvalumab Procedure: Surgery Radiation: Radiotherapy||Phase 2|
In the preoperative period, patients who have undergone adequate mediastinal evaluation and are considered operable will be treated with durvalumab 1125 mg IV every 3 weeks (Q3W) in combination with platinum doublet chemotherapy (cisplatin with pemetrexed or docetaxel, depending upon histology).
Patients will undergo postoperative radiation (54Gy) within 4-10 weeks after surgery (unless single station N2 at registration with resultant ypT0N0 after neoadjuvant therapy).
One to 6 weeks after completion of radiation, patients will receive adjuvant durvalumab 1500 mg IV every 4weeks (Q4W) for 1 year.
Patients who do not have surgery due to refusal, physician decision, or local and distant progression will have to discontinue study treatment.
All participants will have imaging assessment prior to surgery after Cycle 2 (Week 6) and after Cycle 4 (Weeks 13 15). Patients will undergo potentially curable surgery as per standard of care.
Patients will undergo imaging assessment every 12 weeks after surgery for 2 years, then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer|
|Actual Study Start Date :||March 10, 2021|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||September 2024|
Combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles.
• 1-6 weeks after completion of radiotherapy, durvalumab 1500 mg IV every 4 weeks will be administered for 13 cycles.
Other Name: Imfinzi
Patients will be re-evaluated following preoperative treatment to assess if patient is still medically fit to withstand surgery. Eligible patients will then undergo lobectomy, bilobectomy, sleeve lobectomy or other extended resection, or a pneumonectomy will be performed at the discretion of the attending thoracic surgeon.
4-10 weeks after surgery, patients will receive 54 Gy of radiotherapy with single daily fractions.
- N2 nodal clearance (N2NC) [ Time Frame: 5 years ]To increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction from an historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]To evaluate the safety and tolerability of neoadjuvant platinum doublet chemotherapy and durvalumab followed by surgery followed by adjuvant radiation and durvalumab.
- Radiographic response rate [ Time Frame: 5 years ]To assess the radiographic response rate of neoadjuvant platinum doublet chemotherapy and durvalumab.
- Rate of major pathologic response and pathologic complete response [ Time Frame: 16 weeks ]To evaluate the rate of major pathologic response and pathologic complete response in the resected primary tumor and lymph nodes following neoadjuvant combination therapy.
- Evaluate event free survival (EFS) [ Time Frame: 5 years ]EFS evaluated from the time of registration to one of the following events, whichever comes first: a) radiographic disease progression, b) local progression as defined by lymph node progression precluding surgery, c) inability to resect the tumor, d) local or distant recurrence, e) death due to any cause.
- Overall survival rate [ Time Frame: 5 years ]To evaluate overall survival rate from the time of registration
- Rate of complete resection. [ Time Frame: 16 weeks ]To assess the rate of complete resection.
- Post-operative complications [ Time Frame: Within 30 days of surgery ]To assess post-operative complications
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): NCT04062708
|Contact: Licia Adouanefirstname.lastname@example.org|
|United States, Arizona|
|Mayo Clinic||Not yet recruiting|
|Phoenix, Arizona, United States, 85054|
|Principal Investigator: Helen J Ross, MD|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Raphael Bueno, MD|
|United States, Michigan|
|St. Joseph Mercy Hospital||Not yet recruiting|
|Ypsilanti, Michigan, United States, 48197|
|Principal Investigator: Philip Stella, MD|
|United States, Minnesota|
|Mayo Clinic Rochester||Not yet recruiting|
|Rochester, Minnesota, United States, 55901|
|Principal Investigator: Shanda Blackmon, MD|
|United States, New York|
|Roswell Park Comprehensive Cancer Center||Not yet recruiting|
|Buffalo, New York, United States, 14263|
|Principal Investigator: Sai Yendamuri, MD|
|SUNY Upstate Medical University||Recruiting|
|Syracuse, New York, United States, 13210|
|Principal Investigator: Stephen Graziano, MD|
|United States, North Carolina|
|Duke University Medical Center||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator: Betty Tong, MD|
|United States, Oklahoma|
|Stephenson Cancer Center||Not yet recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator: Vipul Pareek, MD|
|United States, Virginia|
|University of Virginia Health System||Not yet recruiting|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator: Linda W Martin|
|Principal Investigator:||Monica Bertagnolli, MD||Alliance Foundation Trials, LLC.|
|Study Chair:||Linda Martin, MD, MPH||University of Virginia|
|Study Chair:||Jyoti Patel, MD||University of Chicago|
|Study Chair:||James Urbanic, MD||University of California, San Diego|