Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants with Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

JRCT ID: jRCT2051220100

Registered date:28/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 14/10/2020
• Target sample size: 300
• Countries of recruitment: United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Drug: Dostarlimab
Dostarlimab will be administered.

Drug: GSK4428859A
GSK4428859A will be administered.

Drug: GSK6097608
GSK6097608 will be administered.

Drug: Pembrolizumab
Pembrolizumab will be administered.

Outcome(s)

• Primary Outcome: To evaluate the antitumor activity of novel immunotherapy combinations compared with pembrolizumab in participants with PD-L1-high (TC/TPS>=50%) NSCLC

Secondary Outcome

-To assess the dose-response relationship of novel immunotherapy combinations across a range of the novel components' dose levels and fixed dostarlimab dose (may not apply to all novel combinations)
-To further assess the clinical activity of novel immunotherapy combinations compared with pembrolizumab in participants with PD-L1-high (TC/TPS>=50%) NSCLC
-To evaluate the antitumor activity of novel immunotherapy combinations via treatment arm comparisons for assessment of contribution of components for the combination regimens
-To further characterize the safety of novel immunotherapy combinations
-To determine the immunogenicity of individual agents comprising novel immunotherapy combinations
-To characterize the PK properties of novel immunotherapy combinations

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Participant must be more than or equal to (>=)18 years of age.
Has a histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or nonsquamous).
Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.
Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC.
Has a PD-L1-high (TC/TPS-50%) tumor as determined by the DAKO 22C3 or VENTANA SP263 assay performed by a local laboratory or by the VENTANA SP263 assay at a central laboratory.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Adequate organ function per protocol specifications.
Male or female participants.
Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception.

Exclude criteria

-Has NSCLC with a tumor that harbors any of the following molecular alterations:
a.EGFR mutations that are sensitive to available targeted inhibitor therapy
b.ALK translocations that are sensitive to available targeted inhibitor therapy.
c.Any otherknown 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.
-Has had major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30Gy within 6months of the first dose of study intervention.
-Has received prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting PD-1, PD-L1, CTLA-4, TIGIT, CD96, or other checkpoint pathways.
-Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime.
-Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5years.
-Has known symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease.
-Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
-Has symptomatic ascites or pleural effusion

Related Information

• Primary Sponsor: Ishibashi Hideyasu
• Secondary ID(s): NCT05565378