OncoMatch/Clinical Trials/NCT04991025
Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery
Official title: Phase 2 Trial of Neoadjuvant Nivolumab + Platinum-based Chemotherapy + Certolizumab in Patients With Resectable Stages II-III Lung Cancers
Is NCT04991025 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for lung cancer.
Treatment: Cisplatin · Pemetrexed · Gemcitabine · Carboplatin · Certolizumab · Nivolumab · Paclitaxel — The purpose of the study is to explore adding the study drug certolizumab to standard chemotherapy as it may reduce the inflammation caused by the cancer and make the chemotherapy more effective in shrinking the cancer. This study will examine whether adding certolizumab to the usual treatment approach is better than, the same as, or worse than the usual approach alone.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage II, III
Prior therapy
Cannot have received: TNF-alpha inhibitor
Prior use of TNF-α inhibitor
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Cannot have received: immune checkpoint blockade therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1)
Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9 /L; Lymphocyte count ≥0.5 x10^9/L (500/µL); Hemoglobin ≥ 9 g/dL; Platelets ≥ 100 x 10^9 /L; Serum albumin ≥25 g/L (2.5 g/dL)
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal
Liver function
Serum total bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's Syndrome); AST and ALT ≤ 2.5 x ULN
Adequate bone marrow, liver and renal function, as specified below: ANC ≥ 1.5 x 10^9 /L; Lymphocyte count ≥0.5 x10^9/L (500/µL); Hemoglobin ≥ 9 g/dL; Platelets ≥ 100 x 10^9 /L; Serum total bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's Syndrome); AST and ALT ≤ 2.5 x ULN; Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal; Serum albumin ≥25 g/L (2.5 g/dL)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity) · Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities) · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04991025 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages