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OncoMatch/Clinical Trials/NCT04991025

Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery

Is NCT04991025 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for lung cancer.

Phase 2RecruitingMemorial Sloan Kettering Cancer CenterNCT04991025Data as of May 2026

Treatment: Cisplatin · Pemetrexed · Gemcitabine · Carboplatin · Certolizumab · NivolumabThe 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Required: Stage II, III

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: TNF-α 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

Cannot have received: systemic immunosuppressive medication (corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide)

Exception: acute, low-dose or one-time pulse dose; mineralocorticoids; corticosteroids for COPD/asthma; low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency; topical steroids

Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment

Cannot have received: systemic immunostimulatory agent (interferon, interleukin 2)

Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment

Cannot have received: investigational therapy

Treatment with investigational therapy within 28 days prior to initiation of study treatment

Cannot have received: therapeutic oral or IV antibiotics

Exception: prophylactic antibiotics

Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment

Cannot have received: allogeneic stem cell or solid organ transplantation

Prior allogeneic stem cell or solid organ transplantation

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

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: ... (see full details above)

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 →

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