Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Dostarlimab plus Belrestotug: 1) Dostarlimab (500 mg Q3W) plus Belrestotug (400 mg Q3W)
2) Frequency- once every 3 weeks
3) Route of Administration- IV infusion
4) Total Duration- will
Sponsors
GlaxoSmithKline
Eligibility
Inclusion criteria
Inclusion criteria: 1)Participants are eligible to be included in the study only if all of the following criteria apply 2)Is capable of giving signed informed consent having age atleast 18 or the legal age of consent in the jurisdiction in which the study is taking place 3)ALocally advanced, unresectable NSCLC (not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy), or Metastatic NSCLC. 4)Has not received prior systemic therapy. 5)Has a PD-L1-high (TC ïâ??³50%) tumor as determined by the VENTANA PD-L1(SP263) CDx Assay at a central laboratory. 6)Has an ECOG PS score of 0 or 1 and adequate organ function. 7)If of childbearing potential, female participants must be willing to use contraception. 8)Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply- 1. Has NSCLC with a tumor that harbors any of the following molecular alterations: a. EGFR mutations that are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19, exon 20 insertion mutation, and exon 21 [L858R] substitution mutation). All participants with nonsquamous histology must have been tested for EGFR mutation status using a tissue-based test; use of an approved test is strongly encouraged. Participants with squamous histology do not need to be tested for EGFR mutation status. Participants with nonsquamous histology and unknown or indeterminate EGFR status are excluded. b. ALK translocations that are sensitive to available targeted inhibitor therapy. All participants with nonsquamous histology must have been tested for ALK fusion mutation status using a tissue-based test; use of an approved test is strongly encouraged. Participants with squamous histology do not need to be tested for ALK fusion mutation status. Participants with nonsquamous histology and unknown or indeterminate ALK status are excluded. c. Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC. 2) Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events equal to or more than than grade 1) 3) Has received prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, CTLA-4, TIGIT, or other checkpoint pathways 4) Has never smoked, defined as smoking less than 100 tobacco cigarettes in a lifetime 5) Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years,except as noted below: a. Participants may be enrolled in the study with a history of any other invasive malignancy for which the participant was definitively treated, from which the participant has been disease-free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted malignancy. b. Participants with curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, and/or in situ breast cancer may be enrolled in the study. 6) Has either of the following: a. Known symptomatic, untreated, or actively progressing brain metastases. b. Any leptomeningeal disease (regardless of symptomatology, treatment status, or stability). 7) Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years. Replacement therapies (e.g., insulin, thyroxine, or physiologic doses of corticosteroids for treatment of adrenal or pituitary insufficiency) are not considered systemic treatments and are allowed. 8) Has received systemic steroid therapy within 3 days prior to the first dose of study intervention or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. a. Corticosteroid use is allowed as pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival per RECIST 1.1 by Blinded independent central review Overall survival Timepoint: Time point - defined as the time from the date of randomization to the date of first documented Progressive disease or death due to any cause, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| To Evaluate Efficacy- Objective response rate - defined as the percentage of participants with a confirmed Complete response or confirmed Partial Response per RECIST 1.1 by investigator assessmentTimepoint: End of study;To Evaluate Efficacy- ââ?¬Â¢ Molecular response rate, defined as the percentage of participants with a molecular response ââ?¬Â¢ Progression-free survival per RECIST 1.1 by investigator assessment, Timepoint: The time from the date of randomization to the date of first documented Progressive disease or death due to any cause, whichever comes first ;To Evaluate Efficacy- Duration of response per RECIST 1.1 by investigator assessment,Timepoint: Time from the date of first confirmed response (Complete Response or Partial Response) to the date of first documented Progressive Disease or death due to any cause, whichever comes first;To Evaluate Efficacy- Time to first subsequent therapyTimepoint: Time from the date of randomization to the date of the first subsequent anticancer therapy or death, whichever occurs first ;To Evaluate Safety ââ?¬Â¢ Incidence of Treatment-emergent adverse events, Serious Adverse Events, & Adverse Events of Special Interest ââ?¬Â¢ Incidence of Treatment-emergent adverse events/Serious Adverse Events leading to dose modifications or treatment discontinuations Timepoint: From administration of first dose to end of study or consent withdrawal which ever comes first. | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Netherlands, Panama, Philippines, Poland, Portugal, Republic of Korea, Romania, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactSwapnali Raut
GSK Pharma India Private Limited
Outcome results
None listed