Trial results for the Phase 1/2 study (NCT03559049) investigating pembrolizumab in combination with rucaparib as maintenance therapy for Stage IV non-squamous non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2026-02-12. The study reported a median duration of time from the start of treatment to progression of 10.6 months.
Background
The study investigated pembrolizumab and rucaparib as maintenance therapy for patients with Stage IV non-squamous non-small cell lung cancer (NSCLC). This therapy was administered to patients who had not experienced progressive disease after induction therapy with carboplatin, pemetrexed, and pembrolizumab.
Trial design
The study (NCT03559049) was a Phase 1/2, multi-center, single-arm trial that enrolled 25 participants. The trial assessed the safety and efficacy of oral rucaparib plus intravenous pembrolizumab as maintenance therapy. Participants had Stage IV non-squamous non-small cell lung cancer and had not experienced progressive disease after prior induction therapy with carboplatin, pemetrexed, and pembrolizumab.
Key results
Key measurements from the trial provided insights into the duration of response and overall survival for the maintenance therapy:
- The median duration of time from the start of treatment to time of progression was 10.6 months.
- The median duration of time from the start of treatment until death was 37.6 months.
- The response rate, measured as the count of participants, was observed in 9 participants.
What this means
The results from this Phase 1/2 single-arm study provide descriptive data on the outcomes of rucaparib and pembrolizumab as maintenance therapy in a specific population of patients with Stage IV non-squamous non-small cell lung cancer. The observed median time to progression of 10.6 months and median overall survival of 37.6 months offer initial insights into the potential activity of this combination in patients who have responded to prior induction therapy. As a single-arm study, these findings are exploratory and would typically inform further research into this treatment approach.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03559049, titled "Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer," were posted on 2026-02-12 on clinicaltrials.gov.