Triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) Cancer Malignant neoplasm of breast, Malignant neoplasm of bronchus and lung, Malignant neoplasm of kidney, except renal pelvis
Conditions
Interventions
Current interventions as of 07/05/2026:
Interventions: ALL cohorts
IMP: Celecoxib
Form: Capsule
Dose: 200 mg twice daily for 13 weeks then 100 mg twice daily (continuous until disease progression or
patients who are no longer also receiving concurrent Nab-paclitaxel can receive 1680mg d1 of a 28-day cycle or 1875mg subcutaneously day 1 of a 21-day cycle)
Route: intravenous (IV)
IMP: Nab-paclitax
Sponsors
Christie Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 07/05/2026: All cohorts: 1. Written informed consent obtained 2. Age = 18 years at the time of screening. 3. No prior treatment for metastatic or locally advanced, incurable disease. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment. 5. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline. 6. Adequate organ and bone marrow function as defined below 6.1. Haemoglobin = 9.0 g/dL 6.2. Absolute neutrophil count = 1.5 x 10^9/l 6.3. Platelet count = 100 x 10^9/l 6.4. Serum bilirubin = 1.5 x ULN. In patients with a confirmed diagnosis of Gilbert’s syndrome then an isolated bilirubin of = 3 x ULN is permitted. 6.5. ALT and AST = 2.5 x ULN 6.6. Creatinine clearance = 40mL/min calculated by Cockcroft-Gault (using actual body weight) OR by measured 24-hour urine collection. 7. Provision of an FFPE tumour sample taken within 12 months of trial registration. 8. Eligible for immune-checkpoint blockade therapy according to the relevant Blueteq/NHSE eligibility criteria with approval requested and confirmed. 9. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the study drug (see definition in section 10.4). 10. WOCBP must agree to follow instructions in Section 8.3.2 for method(s) of contraception for the duration of treatment with study drugs plus 5 months after the completion of trial therapy. 11. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 months after completion of treatment. 12. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, participating WOCBP must still undergo pregnancy testing. Tumour-specific inclusion criteria: Triple Negative Breast cohort 1. Locally confirmed TNBC determined from the most recent tumour sample taken for diagnostic purposes defined: 1.1 Negative for ER with 6 months from the final cycle to the diagnosis of recurrence. Renal Cell Carcinoma Cancer cohort 1. Locally advanced or metastatic renal cell carcinoma that is of a histological subtype eligible for treatment with ipilimumab and nivolumab 2. Intermediate or poor-risk advanced renal ce
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 14/05/2024: All cohorts: 1. History of another malignancy within the last 5 years except adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS); stage 1, grade I endometrial carcinoma. 2. History of leptomeningeal metastases 3. Known symptomatic CNS metastases or symptoms suspicious of CNS metastases are excluded unless: 3.1. Symptomatic lesions have been definitively treated with surgery or stereotactic surgery (whole-brain radiation may be given as adjuvant treatment), and do not require steroids for control of symptoms 3.2. Are asymptomatic without the use of steroids. 4. Current use of a prohibited medication as described in section 9.7.2. 5. Patients known to be CYP2C9-poor metabolisers. 6. Has received a live vaccine within 30 days of the first dose of study treatment. 7. Contraindications to COX-inhibitor dosing including hypersensitivity. 8. Hypersensitivity to sulphonamides. 9. Significant cardiovascular disease including a history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months or clinically significant congestive heart failure. 10. Any other serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that in the opinion of the investigator could interfere with the patient’s safety, obtaining informed consent, or compliance with study procedures. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection. 12. Patients with active, known or suspected autoimmune disease. The following are exceptions to this criterion: 12.1. Patients with vitiligo or alopecia 12.2. Patients with hypothyroidism stable on hormone replacement 12.3. Patients with any chronic skin condition that does not require systemic therapy 13. Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily Prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. 14. Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity. 15. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely in to interfere with absorption of the trial medication. 16. Females who are pregnant or breast-feeding. 17. Any unresolved toxicity NCI CTCAE Grade = 2 from previous anti-cancer therapy with the exception of alopecia and vitiligo. 18. Active infection requiring systemic treatment. 19. Any concomitant chemotherapy, IP or biologic for cancer treatment. Bisphosphonates or Denosumab are acceptable for patients with bone metastases 20. Current or previous regular use of Aspirin (at any dose) or current use of another NSAID for any indication 21. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments. 22. Prisoners or patients who are involuntarily incarcerated. 23. Patients who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. Previous participant exclusion criteria: All cohorts: 1. History of another malignancy within the last 5 years except adequately treated non-melanoma skin cancer; curatively treated in si
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall response rate (complete response plus partial response) using RECIST criteria and CT scan during the course of follow-up. For all cohorts a minimum follow-up of 6 months for all patients who do not experience progression prior to 6 months post start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival measured as the time from recruitment to death by any cause using medical records during the course of follow-up 2. Progression-free survival (PFS) measured as the time from recruitment to disease progression (RECIST 1.1) or death by any cause using CT scan, medical records during the course of follow-up 3. Best overall response rate over 6 months measured by RECIST 1.1 criteria and CT scan at the 6-month follow-up visit 4. Time from initial progression defined by RECIST 1.1 to secondary progression measured using CT scan during the course of follow-up 5. Quantity and grade of toxicity observed when adding celecoxib to standard of care, assessed using all adverse events/serious adverse events Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by clinical assessment during the course of follow-up 6. Response rate at PD-L1 expression of =1%, =5% and =50% measured using immunohistochemistry, CT scans during the course of follow-up 7. PFS at PD-L1 expression of =1%, =5% and =50% measured using immunohistochemistry, CT scans during the course of follow-up For all cohorts a minimum follow-up of 6 months for all patients who do not experience progression prior to 6 months post start of treatment | — |
Countries
England, United Kingdom
Contacts
Public ContactLION Trial Coordinator
Outcome results
None listed