Trial results for a Phase 1/2 study investigating nivolumab, ipilimumab, and nintedanib in non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-03-25. The study demonstrated that the combination therapy in Arm A achieved a median overall survival of 17.1 months, compared to 8.2 months in Arm B.
Background
The study, titled "Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer," aimed to assess the efficacy, safety, and tolerability of this triple combination in patients with non-small cell lung cancer.
Trial design
The study (NCT03377023) was a Phase 1/2 trial with an enrollment of 66 participants. It investigated the combination of nivolumab, ipilimumab, and nintedanib in patients with non-small cell lung cancer, non-small cell lung cancer metastatic, and lung cancer, non-small cell. The main purpose was to determine the effectiveness, safety, and tolerability of the combination. The trial included a dose escalation phase (Phase 1) and two treatment arms (Phase 2 - Arm A and Phase 2 - Arm B).
Key results
In Phase 1, the maximum tolerated dose (MTD) was determined to be 150 miligrams nintedanib. In Phase 2, key efficacy outcomes were reported for Arm A and Arm B:
- Objective Response Rate (ORR):
- Phase 2 - Arm A: 40.9 percentage of participants (95% Confidence Interval)
- Phase 2 - Arm B: 21.4 percentage of participants (95% Confidence Interval)
- Disease Control Rate (DCR):
- Phase 2 - Arm A: 72.7 percentage of participants (95% Confidence Interval)
- Phase 2 - Arm B: 57.1 percentage of participants (95% Confidence Interval)
- Overall Survival (OS):
- Phase 2 - Arm A: Median of 17.1 months (95% Confidence Interval)
- Phase 2 - Arm B: Median of 8.2 months (95% Confidence Interval)
- Progression-free Survival (PFS):
- Phase 2 - Arm A: Median of 5.5 months (95% Confidence Interval)
- Phase 2 - Arm B: Median of 2.6 months (95% Confidence Interval)
What this means
The results from this Phase 1/2 study indicate that the combination of nivolumab, ipilimumab, and nintedanib in Arm A demonstrated higher objective response rates, disease control rates, and longer median overall survival and progression-free survival compared to Arm B. These findings suggest a potential clinical benefit for patients with non-small cell lung cancer with this triple combination therapy, warranting further investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03377023, titled "Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer," were posted on 2025-03-25 on clinicaltrials.gov.