About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Pembrolizumab (neoadjuvant)
Biological/VaccineBefore surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles
Cisplatin
DrugCisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
Gemcitabine
DrugIn squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.
Pemetrexed
DrugIn nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
Sacituzumab tirumotecan
DrugSacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles
H1 receptor antagonist
DrugAdministered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
H2 receptor antagonist
DrugAdministered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Acetaminophen (or equivalent)
DrugAdministered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Dexamethasone (or equivalent)
DrugAdministered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label
Carboplatin
DrugAUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles
Pembrolizumab (adjuvant)
Biological/VaccineAfter surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles
Paclitaxel
DrugPaclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.
Steroid mouthwash (dexamethasone or equivalent)
DrugAdministered orally as rescue medication 2-5 mL 4 times daily
Treatment groups
Trial outcomes
Primary outcomes
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.
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.)
Secondary outcomes
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.
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.
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.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.