Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)
18 Years and older, Male and Female
205801 (primary)
NCI-2018-03390
Summary
This study will compare the clinical activity of novel regimens (in combination or as
single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study
will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part
based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to
generate additional data to qualify novel regimens for the randomized study. Part 2 is a
randomized, Phase II open-label part comparing the efficacy and safety of these novel
regimens with SoC. Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are
interchangeable for the same compound and will be referred to as
GSK4428859A/EOS884448/belrestotug.
Eligibility
- Participants capable of giving signed informed consent/assent.
- Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
- Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and a) Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody (mAb) containing regimen. b) Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration. c) Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
- Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
- Adequate organ function as defined in the protocol.
- A male participant must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply: i) Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- Life expectancy of at least 12 weeks.
Treatment Sites in Georgia
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