Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
1 mg Intramuscular (IM) Injection
200 mg IV Infusion
Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion
200 or 175 mg/m\^2 IV Infusion
100 mg/m\^2 IV Infusion
Placebo matched to Intismeran Autogene IM injection
Moffitt Cancer Center ( Site 0021)
Tampa, Florida, United States
RECRUITINGVA Ann Arbor Healthcare System ( Site 0019)
Ann Arbor, Michigan, United States
RECRUITINGWashington University School of Medicine ( Site 0024)
St Louis, Missouri, United States
RECRUITINGValley Health Systems - Ridgewood Campus ( Site 0010)
Paramus, New Jersey, United States
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to ~32 months
Overall Survival (OS)
OS, defined as the time from randomization to death due to any cause. OS will be presented.
Time frame: Up to ~42 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Time frame: Up to ~26 months
Duration of Response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame: Up to ~42 months
Number of Participants who Experience an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.
Time frame: Up to ~42 months
Number of Participants who Discontinue Study Intervention Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be presented.
Time frame: Up to ~24 months
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New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)
Albany, New York, United States
RECRUITINGCleveland Clinic - Ohio ( Site 0016)
Cleveland, Ohio, United States
RECRUITINGGood Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)
Corvallis, Oregon, United States
RECRUITINGTennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)
Nashville, Tennessee, United States
RECRUITINGTexas Oncology - Central/South Texas ( Site 8002)
Austin, Texas, United States
RECRUITINGVirginia Cancer Specialists ( Site 0003)
Fairfax, Virginia, United States
RECRUITING...and 45 more locations