Lung Neoplasm Malignant
Conditions
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Brief summary
The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.
Interventions
BIOLOGICALPembrolizumab (neoadjuvant)
Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles
DRUGCisplatin
Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
DRUGGemcitabine
In squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.
DRUGPemetrexed
In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
DRUGSacituzumab tirumotecan
Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label
DRUGCarboplatin
AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles
BIOLOGICALPembrolizumab (adjuvant)
After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles
DRUGPaclitaxel
Paclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.
Administered orally as rescue medication 2-5 mL 4 times daily
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion and
Exclusion criteria
include but are not limited to the following: Inclusion Criteria: * Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) * Able to undergo protocol therapy, including necessary surgery * Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy * Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention. * Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | Up to approximately 20 weeks | pCR is defined as absence of residual viable invasive cancer on hematoxylin- and eosin-stained slides of the resected lung specimen and lymph nodes. |
| Percent Residual Viable Tumor (%RVT) | Up to approximately 20 weeks | %RVT is defined as the percentage of residual tumor estimated by comparing the estimated cross-sectional area of viable tumor with estimated cross-sectional areas of remainder of tumor bed. The tumor bed is defined as the area of tissue occupied by viable tumor or tumoral regression (includes areas of necrosis, foamy macrophages, giant cell reaction, cholesterol cleft granuloma, and inflammation.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Report at Least 1 Adverse Event (AE) | Up to approximately 5 years | 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. |
| Percentage of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 1 year | 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. |
| Event-free Survival (EFS) | Up to approximately 5 years | EFS is defined as the time from randomization to any of the following events: radiographic disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) (for participants who have not had or will not have surgery, or participants who have gross residual disease after an incomplete resection \[R2 resection\]); local progression (primary tumor or regional lymph nodes) or distant metastasis precluding planned surgery; tumor determined to be unresectable in the operating room; local or distant recurrence (for participants who are disease free after surgery or participants with microscopic positive margins \[R1 resection\]); occurrence of new primary NCSLC; death due to any cause. |
| Overall Survival (OS) | Up to approximately 5 years | OS is defined as the time from randomization to death due to any cause. |
| Distant Metastasis-Free Survival (DMFS) | Up to approximately 5 years | DMFS is defined as the time from randomization to the date of diagnosis of distant metastasis or death, whichever occurs first. |
| Objective Response Rate (ORR) | Up to approximately 12 weeks | OR is defined as a complete response or partial response with or without confirmation per RECIST 1.1 as assessed by the investigator during the Neoadjuvant Phase. |
| Percentage of Participants Who Experience a Perioperative Complication | Up to approximately 20 weeks | Perioperative Complications include both intraoperative and postoperative complications. |
| Mean Length of Hospital Stay | Up to approximately 20 weeks | Hospital Stay is the length of inpatient time spent in hospital. |
| Percentage of Participants Who Require Hospital Readmission after Discharge | Up to approximately 20 weeks | In participants previously discharged from hospital, the percentage requiring readmission to hospital. |
| Mean Length of Surgery | Up to approximately 20 weeks | Length of surgery is the time spent in surgery. |
| Percentage of Participants Who Require a Blood Transfusion | Up to approximately 20 weeks | Blood transfusion is the transfer of donated blood into the vein of a recipient. |
Countries
Chile, Greece, Hungary, Italy, Poland, Spain, Turkey (Türkiye), Ukraine, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed