Trial results for the study NCT03366766, investigating nivolumab plus cisplatin/pemetrexed or cisplatin/gemcitabine as induction therapy in resectable non-small cell lung cancer, were posted on ClinicalTrials.gov on 2026-02-20. The study reported a major pathologic response (mpCR) of 78.6% for the combined cohort of patients.
Background
The study, titled "Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer," investigated the use of nivolumab in combination with chemotherapy regimens. The trial focused on patients with resectable non-small cell lung cancer, specifically those with Non-Squamous Non-Small Cell Lung Carcinoma, and Stage I, Stage IA, Stage IB, or Stage II Non-Small Cell Lung Cancer.
Trial design
The study NCT03366766 was a Phase 2 trial that was ultimately TERMINATED. It enrolled 14 participants across two cohorts. Primary outcomes for the study were not reported. Cohort I received nivolumab, cisplatin, and pemetrexed disodium. Cohort II received nivolumab, cisplatin, and gemcitabine hydrochloride.
Key results
The trial reported several key measurements:
- For "Major Pathologic Response (mpCR) Defined as < 10% Viable Tumor":
- Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium): 75% of participants.
- Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride): 80.0% of participants.
- Combined Cohort (All Patient Receiving Nivolumab IV): 78.6% of participants.
- For "Number of Adverse Events":
- Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium): 12 adverse events.
- Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride): 122 adverse events.
- For "Progression Free Survival" (Probability of Survival):
- Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium): 1.00.
- Cohort II (Nivolumab, Cisplatin, Gemcitabine Hydrochloride): 0.9.
- Combined Cohort (All Patients Receiving Nivolumab IV): 0.93.
- For "Overall Survival" (Probability of Survival):
- Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium): 1.00.
- Cohort I (Nivolumab, Cisplatin, Gemcitabine Hydrochloride): 0.9.
- Combined Cohort (All Patient Receiving Nivolumab IV): 0.93.
- For "Overall Clinical Response":
- Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium): 0 Participants.
What this means
The results from this Phase 2 trial suggest that nivolumab in combination with either cisplatin/pemetrexed or cisplatin/gemcitabine as induction therapy can achieve a high major pathologic response in patients with resectable non-small cell lung cancer. The observed high probabilities for progression-free survival and overall survival are also notable. While the trial was terminated and involved a small enrollment of 14 participants, these findings provide preliminary insights into the potential efficacy of such regimens in this patient population. The difference in reported adverse events between cohorts, 12 versus 122, warrants further investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03366766, titled "Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer," were posted on 2026-02-20 on clinicaltrials.gov.