PH2a, Platform Study of Novel Immunotherapy Combinations in Participants with Previously Untreated, Advanced/Metastatic NSCLC
- Conditions
- ung Cancer, Non-Small CellTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505057-40-00
- Lead Sponsor
- Glaxosmithkline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 280
Is capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol., If of childbearing potential, female participants must be willing to use adequate contraception. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: Is a woman of non-childbearing potential as defined in the protocol or Is a woman of childbearing potential and using a contraceptive method that is highly effective as described in the protocol Female participant agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. A woman of childbearing potential must not be pregnant, Is, at the time of signing the ICF, at least 18 years old or the legal age of consent in the jurisdiction in which the study is taking place., 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, Has measurable disease based on RECIST 1.1 as determined by the investigator., Has an ECOG PS of 0 or 1., Has adequate organ function as defined in the protocol
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 mutation status. Participants with nonsquamous histology and with 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., Has a known HIV infection., Has a history of severe hypersensitivity to mAbs or to any of the excipients in the formulations of the components of the study interventions, Has received any live vaccine within 30 days prior to first dose of study intervention., Has any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric, or other condition that could, in the opinion of the investigator, interfere with participant’s safety, obtaining informed consent, or compliance with the study procedures, Has symptomatic ascites, pleural effusion, or pericardial effusion., Has active inflammatory bowel disease, acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis, Has a history or evidence of cardiac abnormalities within the 6 months prior to enrollment, Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis., Has had major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30 Gy (for any purpose, including palliatively) within 6 months prior to the first dose of study intervention., Has received prior therapy with any immune-checkpoint inhibitors, Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime, Is, at the time of signing the ICF, a regular user (including recreational use) of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol) that, in the opinion of the investigator, would interfere with the evaluation of the study intervention or interpretation of safety., Has a positive test for the presence of HBsAg at Screening or within 3 months prior to first dose of study intervention., Has a positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study intervention., Has a positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention., Has advanced, symptomatic, or visceral spread and is considere
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method