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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles
Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
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.
Pathological Complete Response (pCR)
pCR is defined as absence of residual viable invasive cancer on hematoxylin- and eosin-stained slides of the resected lung specimen and lymph nodes.
Time frame: Up to approximately 20 weeks
Percent Residual Viable Tumor (%RVT)
%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.)
Time frame: Up to approximately 20 weeks
Percentage of Participants Who Report at Least 1 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 approximately 5 years
Percentage of Participants Who Discontinue Study Treatment Due to an 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 approximately 1 year
Event-free Survival (EFS)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
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
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
After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles
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
Sansum Clinic (Ridley Tree) ( Site 8012)
Santa Barbara, California, United States
RECRUITINGMedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States
RECRUITINGCentro de Estudios Clínicos SAGA ( Site 0162)
Santiago, Region M. de Santiago, Chile
RECRUITINGFALP ( Site 0161)
Santiago, Region M. de Santiago, Chile
RECRUITINGBradfordhill ( Site 0160)
Santiago, Region M. de Santiago, Chile
RECRUITINGAlexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)
Athens, Attica, Greece
RECRUITINGATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)
Athens, Attica, Greece
RECRUITINGMetropolitan Hospital-4th Oncology Dept ( Site 0201)
Athens, Attica, Greece
RECRUITINGUniversity General Hospital of Heraklion ( Site 0200)
Heraklion, Irakleio, Greece
RECRUITINGPetz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)
Győr, Győr-Moson-Sopron, Hungary
RECRUITING...and 18 more locations
Time frame: Up to approximately 5 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 5 years
Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from randomization to the date of diagnosis of distant metastasis or death, whichever occurs first.
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
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.
Time frame: Up to approximately 12 weeks
Percentage of Participants Who Experience a Perioperative Complication
Perioperative Complications include both intraoperative and postoperative complications.
Time frame: Up to approximately 20 weeks
Mean Length of Hospital Stay
Hospital Stay is the length of inpatient time spent in hospital.
Time frame: Up to approximately 20 weeks
Percentage of Participants Who Require Hospital Readmission after Discharge
In participants previously discharged from hospital, the percentage requiring readmission to hospital.
Time frame: Up to approximately 20 weeks
Mean Length of Surgery
Length of surgery is the time spent in surgery.
Time frame: Up to approximately 20 weeks
Percentage of Participants Who Require a Blood Transfusion
Blood transfusion is the transfer of donated blood into the vein of a recipient.
Time frame: Up to approximately 20 weeks