NADIM II: Neo-Adjuvant Immunotherapy

Summary

This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial. 90 patients will be enrolled in this trial to examine the pathological Complete Response defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.

Timeline

Start

2019-05-15

Primary completion

2027-11-30

Completion

2028-11-30

Outcome

Met primary endpoint

paper (relative risk, 5.34; 95% confidence interval [CI], 1.34 to 21.23; P = 0.02). PMID 37379158 ↗

Publications

• Sierra-Rodero B, Gil-Gonzalez A, Molina-Alejandre M, Nadal E, Calvo V, Lazaro M, Insa A, Massuti B, Martinez Marti A, de Castro J, Garcia Campelo R, Gonzalez Larriba JL, Bernabe R, Domine M, Ponce Aix S, Cobo M, Camps C, Reguart N, Bosch-Barrera J, Majem M, Aguilar A, Palmero R, Blanco Clemente M, Martin-Lopez J, Munoz-Viana R, Megias D, Gutierrez-Escobedo JM, Martinez-Toledo C, Cruz-Bermudez A, Provencio M. Decoding B-cell Signatures of Complete Pathologic Response to Perioperative Chemoimmunotherapy in Non-Small Cell Lung Cancer. Clin Cancer Res. 2026 Apr 15;32(8):1499-1512. doi: 10.1158/1078-0432.CCR-25-3315.
• Provencio M, Nadal E, Gonzalez-Larriba JL, Martinez-Marti A, Bernabe R, Bosch-Barrera J, Casal-Rubio J, Calvo V, Insa A, Ponce S, Reguart N, de Castro J, Mosquera J, Cobo M, Aguilar A, Lopez Vivanco G, Camps C, Lopez-Castro R, Moran T, Barneto I, Rodriguez-Abreu D, Serna-Blasco R, Benitez R, Aguado de la Rosa C, Palmero R, Hernando-Trancho F, Martin-Lopez J, Cruz-Bermudez A, Massuti B, Romero A. Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):504-513. doi: 10.1056/NEJMoa2215530. Epub 2023 Jun 28.

Drugs

Indications