- Year: 2023
- Title: NADIM II
- Subtitle: Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer
- Trial Type: An open-label, randomized, two-arm, phase II trial
Objective: 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.
Inclusion Criteria:
- 18 Years and older
- Previously untreated patients
- Tumor considered resectable
- ECOG 0-1 and measurable or evaluable disease
Exclusion Criteria:
- Activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene
- Any autoimmune disease, or other active malignancy
Participants: 86 Patients
Treatment Groups:
- Nivolumab + Chemotherapy (n = 57)
- Chemotherapy Alone (n = 29)
Primary Outcome:
- A pathological complete response (%): Nivolumab + Chemotherapy 37, Chemotherapy Alone 7
- RR, 5.34; 95% CI, 1.34 to 21.23 (P=0.02)
Secondary Outcomes:
- Kaplan-Meier estimates of progression-free survival at 24 months (%): Nivolumab + Chemotherapy 67.2, Chemotherapy Alone 40.9
- HR, 0.47; 95% CI, 0.25 to 0.88
- Grade 3 or 4 adverse events (%): Nivolumab + Chemotherapy 19, Chemotherapy Alone 10
Conclusion: In patients with resectable stage IIIA or IIIB NSCLC, perioperative treatment with nivolumab plus chemotherapy resulted in a higher percentage of patients with a pathological complete response and longer survival than chemotherapy alone.
Reference: Providencio M et al. N Engl J Med 2023; 389:504-513