Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants with Previously Untreated Advanced/Metastatic NonSmallCell Lung Cancer
- Conditions
- on-small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-005115-32-PT
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Key Inclusion Criteria
1. Is capable of giving signed informed consent
2. 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.
3. 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). Mixed tumors will be categorized by the predominant cell type; if small cell or neuroendocrine elements are present, the participant is ineligible.
4. Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.
NOTE: Completion of treatment with cytotoxic chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed if therapy was completed at least 6 months prior to the diagnosis of locally advanced or metastatic disease. Prior treatment with neoadjuvant/adjuvant immunotherapy is not permitted.
5. Has a PD-L1-high tumor
6. Has measurable disease based on RECIST 1.1 (Appendix 7), as determined by the investigator.
7. Has an ECOG PS 0 or 1.
8. Has adequate organ function
9. If of childbearing potential, female participants must be willing to use adequate contraception.
Refer protocol for other inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 165
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135
Key Exclusion criteria
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
b. ALK translocations that are sensitive to available targeted inhibitor therapy.
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 major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30 Gy within 6 months of the first dose of study intervention.
3. 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.
4. Has never smoked, defined as smoking <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
6. Has known symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease. Participants who have received prior therapy for brain metastases and have stable CNS disease
7. Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
8. Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.
9. Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible if the participant otherwise meets entry criteria.
10. Has active inflammatory bowel disease, acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis.
11. Has a history or evidence of cardiac abnormalities within the 3 months prior to enrollment
12. QTcF >470 msec, or >480 msec for participants with bundle branch block. QTcF is QT corrected for heart rate according to Fridericia’s formula and can be machine calculated or manually over-read.
13. Has active tuberculosis (i.e., history of exposure or history of positive tuberculosis test, plus presence of clinical symptoms or physical or radiographic findings).
14. Has a known human immunodeficiency virus infection.
15. Has a history of severe hypersensitivity to mAbs or to any of the excipients in the formulations of the components of the study interventions.
16. Has a positive test for the presence of HBsAg at Screening or within 3 months prior to first dose of study intervention.
17. Has a positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study intervention.
NOTE: Participants with a positive hepatitis C antibody test due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
18. Has a positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention.
NOTE: Participants with a negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
Refer protocol for other exclusion criteria
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