The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC. The primary objectives of this study are: Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
593
Administered intravenously
Administered intravenously
Administered intravenously
Administered orally
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Arizona Oncology Associates,Substudy-01
Tucson, Arizona, United States
WITHDRAWNArizona Oncology Associates,Substudy-02
Tucson, Arizona, United States
COMPLETEDRocky Mountain Cancer Center,Substudy-01
Denver, Colorado, United States
WITHDRAWNRocky Mountain Cancer Center,Substudy-02
Denver, Colorado, United States
WITHDRAWNSubstudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response.
Time frame: Up to 5 years
Substudy 03: Complete Pathological Response (pCR) Rate
pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review.
Time frame: Up to 5 years
Substudies 01 and 02: Progression-free Survival (PFS) According to RECIST Version 1.1
PFS is defined as the time from the date of randomization until disease progression (PD) or death, whichever comes first.
Time frame: Up to 5 years
Substudies 01 and 02: Duration of response (DOR) According to RECIST Version 1.1
DOR is defined as the time from the first response (CR or PR) until the first documented PD, or death, whichever comes first.
Time frame: Up to 5 years
All Substudies: Overall survival (OS)
OS is defined as the time from the date of randomization until death from any cause.
Time frame: Up to 5 years
Substudy 03: Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time from randomization until any of the following events: any progression precluding surgery or preventing completion of surgery, progression or recurrence of disease after surgery (local or distant), as assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death due to any cause, whichever occurs first. Participants who do not undergo surgery for reasons other than progression will be considered to have had an event at progression or at death.
Time frame: Up to 5 years
Substudy 03: Major Pathological Response (MPR) Rate
MPR rate is defined as the percentage of participants with ≤ 10% residual tumor in lung and lymph nodes at surgery as evaluated by local pathology review.
Time frame: Up to 5 years
All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs
Time frame: First dose date up to 24 months plus 100 days
All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 24 months plus 100 days
Gilead Clinical Study Information Center
CONTACT
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Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
Fort Wayne, Indiana, United States
RECRUITINGBaptist Health Lexington,Substudy-03
Lexington, Kentucky, United States
RECRUITINGWashington University School of Medicine - Siteman Cancer Center,Substudy-01
St Louis, Missouri, United States
ACTIVE_NOT_RECRUITINGWashington University School of Medicine - Siteman Cancer Center,Substudy-02
St Louis, Missouri, United States
ACTIVE_NOT_RECRUITINGWashington University School of Medicine - Siteman Cancer Center,Substudy-03
St Louis, Missouri, United States
RECRUITINGWashington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
RECRUITING...and 91 more locations