A Phase 3 study (NCT03520686) investigating nivolumab-based regimens for advanced non-small cell lung cancer (NSCLC) reached its primary completion date on 2025-10-13. The trial, however, is currently listed with an 'TERMINATED' overall status on ClinicalTrials.gov.
Background
This study explored various interventions involving nivolumab, a checkpoint inhibitor, in combination with other agents such as nogapendekin alfa inbakicept (NAI), pembrolizumab, ipilimumab, and chemotherapy regimens including carboplatin, nab-paclitaxel, paclitaxel, cisplatin, and pemetrexed. The focus was on participants with Non Small Cell Lung Cancer, a common and often aggressive form of lung cancer.
Trial design
The terminated Phase 3 study (NCT03520686) was an open-label, 4-cohort study, comprising 3 randomized cohorts and 1 single-arm cohort. It enrolled 102 participants with Non Small Cell Lung Cancer. The interventions included: NAI + pembrolizumab; NAI + nivolumab + ipilimumab; NAI + pembrolizumab + carboplatin + nab-paclitaxel or paclitaxel; cisplatin/carboplatin + pemetrexed + pembrolizumab + NAI; and cisplatin/carboplatin + pemetrexed + atezolizumab + NAI. Treatment was planned for up to 2 years, or until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Patients were to be followed for disease progression, post-therapies, and survival for 24 months after the first dose of study drug.
What this means
The primary completion date for this Phase 3 study indicates that the final data collection for the primary outcome measures has occurred. However, the 'TERMINATED' status means the trial was stopped early. This termination could be due to various reasons, such as safety concerns, lack of efficacy, or logistical issues, which are not detailed in the provided data. As no primary outcome measurements or key analyses are available, the clinical implications regarding the efficacy or safety of the investigated nivolumab-based regimens for Non Small Cell Lung Cancer cannot be determined from this update. Clinicians and researchers will need to await further information regarding the reasons for termination and any potential data that may be released.
Source
The information regarding this trial's primary completion and status was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT03520686, titled "Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer", was posted with an event date of 2025-10-13 on clinicaltrials.gov.