Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632327
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares standard therapy given after surgery adjuvant to standard therapy given before and after surgery perioperative in treating patients with stage II-IIIB non-small cell lung cancer NSCLC that can be removed by surgery resectable The usual approach for patients with resectable NSCLC is chemotherapy andor immunotherapy before surgery after surgery or both before and after surgery This study is being done to find out which approach is better at treating patients with lung cancer Treatment will be administered according to the current standard of care at the time of enrollment Chemotherapy options may include cisplatin carboplatin pemetrexed gemcitabine docetaxel and vinorelbine at standard doses according to the treating physician Cisplatin is in a class of medications known as platinum-containing compounds It works by killing stopping or slowing the growth of tumor cells Carboplatin is in a class of medications known as platinum-containing compounds It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin Carboplatin works by killing stopping or slowing the growth of tumor cells Pemetrexed is in a class of medications called antifolate antineoplastic agents It works by stopping cells from using folic acid to make deoxyribonucleic acid DNA and may kill tumor cells Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells Docetaxel is in a class of medications called taxanes It stops tumor cells from growing and dividing and may kill them Other chemotherapy drugs such as vinorelbine work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Immunotherapy with monoclonal antibodies such as nivolumab pembrolizumab and atezolizumab may help the bodys immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC
Detailed Description:
The primary and secondary objectives of the study
PRIMARY OBJECTIVE
I To compare the 3-year real-world event-free survival rwEFS rate and overall survival OS between perioperative and adjuvant immunotherapy-based treatment for patients with resectable non-small cell lung cancer dual endpoints
SECONDARY OBJECTIVES
I To compare the rates of surgical resection between the two arms II To compare the rates of complete resection R0 between the two arms III To summarize and compare rates of adverse events AEs resulting in permanent treatment discontinuation hospitalization or death between the two arms
IV To evaluate the association between locally defined pathological complete response pCR and rwEFS in patients randomized to the perioperative arm arm 2
V To compare the rwEFS post 3-years from randomization between the two arms among patients who do not experience an event by 3 years
EXPLORATORY OBJECTIVES
I To compare outcomes according to the systemic therapy administered on each arm
II To compare the sites of relapse between the two treatment arms
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1
SURGERY Patients undergo surgery within 28 days of registration
ADJUVANT THERAPY Patients receive platinum-based doublet chemotherapy cisplatin carboplatin pemetrexed gemcitabine docetaxel andor vinorelbine for up to 4 cycles and immune checkpoint inhibitor therapy nivolumab pembrolizumab andor atezolizumab for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines
ARM 2
NEOADJUVANT THERAPY Within 28 days of registration patients receive platinum-based doublet chemotherapy cisplatin carboplatin pemetrexed gemcitabine docetaxel andor vinorelbine for up to 4 cycles in combination with immune checkpoint inhibitor nivolumab pembrolizumab andor atezolizumab according to current approved guidelines
SURGERY Patients undergo surgery
ADJUVANT THERAPY Patients receive immune checkpoint inhibitor therapy nivolumab pembrolizumab andor atezolizumab for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines
Patients also undergo computed tomography CT throughout the study and may undergo magnetic resonance imaging MRI andor positron emission tomography PETCT at screening
After completion of study treatment patients are followed up every 6 months for up to 10 years
PRIMARY OBJECTIVE
I To compare the 3-year real-world event-free survival rwEFS rate and overall survival OS between perioperative and adjuvant immunotherapy-based treatment for patients with resectable non-small cell lung cancer dual endpoints
SECONDARY OBJECTIVES
I To compare the rates of surgical resection between the two arms II To compare the rates of complete resection R0 between the two arms III To summarize and compare rates of adverse events AEs resulting in permanent treatment discontinuation hospitalization or death between the two arms
IV To evaluate the association between locally defined pathological complete response pCR and rwEFS in patients randomized to the perioperative arm arm 2
V To compare the rwEFS post 3-years from randomization between the two arms among patients who do not experience an event by 3 years
EXPLORATORY OBJECTIVES
I To compare outcomes according to the systemic therapy administered on each arm
II To compare the sites of relapse between the two treatment arms
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1
SURGERY Patients undergo surgery within 28 days of registration
ADJUVANT THERAPY Patients receive platinum-based doublet chemotherapy cisplatin carboplatin pemetrexed gemcitabine docetaxel andor vinorelbine for up to 4 cycles and immune checkpoint inhibitor therapy nivolumab pembrolizumab andor atezolizumab for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines
ARM 2
NEOADJUVANT THERAPY Within 28 days of registration patients receive platinum-based doublet chemotherapy cisplatin carboplatin pemetrexed gemcitabine docetaxel andor vinorelbine for up to 4 cycles in combination with immune checkpoint inhibitor nivolumab pembrolizumab andor atezolizumab according to current approved guidelines
SURGERY Patients undergo surgery
ADJUVANT THERAPY Patients receive immune checkpoint inhibitor therapy nivolumab pembrolizumab andor atezolizumab for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines
Patients also undergo computed tomography CT throughout the study and may undergo magnetic resonance imaging MRI andor positron emission tomography PETCT at screening
After completion of study treatment patients are followed up every 6 months for up to 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None