Trial results for Nivolumab, administered alone or in combination with ipilimumab or chemotherapy, in treating patients with previously untreated Stage I-IIIA non-small cell lung cancer were posted on ClinicalTrials.gov on 2025-03-05. The study observed major pathologic responses (mPR) across all treatment arms, with the combination of Nivolumab + Ipilimumab + Chemotherapy showing mPR in 11 participants.
Background
This study investigated Nivolumab, an immunotherapy agent, alone and in combination with other treatments for previously untreated Stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies like Nivolumab and Ipilimumab aims to enhance the body's immune response against tumor cells. Chemotherapy drugs, such as cisplatin, docetaxel, and carboplatin, work to inhibit tumor cell growth and division.
Trial design
The study (NCT03158129) was a Phase 2 trial that enrolled 101 participants. It focused on patients with previously untreated Stage I, IA, IB, II, or IIA non-small cell lung cancer. Participants were assigned to one of four treatment arms:
- Arm A: Nivolumab
- Arm B: Nivolumab + Ipilimumab
- Arm C: Nivolumab + Chemotherapy (including carboplatin, cisplatin, or docetaxel)
- Arm D: Nivolumab + Ipilimumab + Chemotherapy (including carboplatin, cisplatin, or docetaxel)
Key outcomes measured included Major Pathologic Response (mPR) and Pathologic Complete Response (pCR).
Key results
The trial reported the following counts of participants achieving Major Pathologic Response (mPR) and Pathologic Complete Response (pCR) across the treatment arms:
- Major Pathologic Response (mPR):
- Arm A (Nivolumab): 5 participants achieved mPR out of 18 evaluated.
- Arm B (Nivolumab + Ipilimumab): 8 participants achieved mPR out of 13 evaluated.
- Arm C (Nivolumab + Chemotherapy): 7 participants achieved mPR out of 15 evaluated.
- Arm D (Nivolumab + Ipilimumab + Chemotherapy): 11 participants achieved mPR out of 11 evaluated.
- Pathologic Complete Response (pCR):
- Arm A (Nivolumab): 2 participants achieved pCR.
- Arm B (Nivolumab + Ipilimumab): 6 participants achieved pCR.
- Arm C (Nivolumab + Chemotherapy): 4 participants achieved pCR.
- Arm D (Nivolumab + Ipilimumab + Chemotherapy): 4 participants achieved pCR.
What this means
These Phase 2 trial results provide early data on the efficacy of Nivolumab in various combinations for patients with previously untreated Stage I-IIIA non-small cell lung cancer. The observed major pathologic responses and pathologic complete responses across the different arms suggest potential clinical activity for these regimens. Specifically, the combination of Nivolumab + Ipilimumab + Chemotherapy demonstrated the highest number of major pathologic responses, while Nivolumab + Ipilimumab showed the highest number of pathologic complete responses. These findings warrant further investigation into these treatment strategies for this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03158129, titled "Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer," were posted on 2025-03-05 on clinicaltrials.gov.