This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
780
Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase
Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.
Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.
Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.
Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.
Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.
UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)
Little Rock, Arkansas, United States
RECRUITINGHighlands Oncology Group-Research Department ( Site 0062)
Springdale, Arkansas, United States
RECRUITINGBeverly Hills Cancer Center ( Site 0070)
Beverly Hills, California, United States
RECRUITINGThe Angeles Clinic and Research Institute ( Site 0040)
Los Angeles, California, United States
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Time frame: Up to ~ 93 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to ~ 118 months
Distant metastasis-free survival (DMFS) as assessed by investigator
DMFS is defined as the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
Time frame: Up to ~ 118 months
Disease-Free Survival (DFS) as assessed by investigator
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Time frame: Up to ~ 118 months
Lung Cancer Specific Survival (LCSS)
LCSS is defined as the time from randomization to the date of death due to lung cancer.
Time frame: Up to ~ 118 months
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to ~ 118 months
Number of Participants Who Discontinue Study Intervention Due to AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be presented.
Time frame: Up to ~ 118 months
Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)
The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is a psychometrically and clinically validated instrument appropriate for assessing the health-related quality of life (HRQoL) of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for the global health status or QoL a higher value indicates a better level of function.
Time frame: Baseline and up to ~118 months
Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5)
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all physical functional scales, a higher value indicates a better level of function.
Time frame: Baseline and up to ~118 months
Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7)
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all role functional scales, a higher value indicates a better level of function.
Time frame: Baseline and up to ~118 months
Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)
The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for symptom scales such as dyspnea, a higher value indicates increased severity of symptoms.
Time frame: Baseline and up to ~118 months
Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)
The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for cough, a higher value indicates increased severity of symptoms.
Time frame: Baseline and up to ~118 months
Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)
The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for chest pain, a higher value indicates increased severity of symptoms.
Time frame: Baseline and up to ~118 months
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The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)
Los Angeles, California, United States
RECRUITINGUCLA Clinical & Translational Research Center (CTRC) ( Site 0033)
Los Angeles, California, United States
RECRUITINGHoag Memorial Hospital Presbyterian ( Site 0096)
Newport Beach, California, United States
RECRUITINGSan Francisco Oncology Associates ( Site 0066)
San Francisco, California, United States
RECRUITINGStamford Hospital ( Site 0083)
Stamford, Connecticut, United States
RECRUITINGMayo Clinic in Florida ( Site 0014)
Jacksonville, Florida, United States
RECRUITING...and 244 more locations