Title: A Randomized Phase II Study Evaluating Pembrolizumab vs Topotecan in the Second-Line Treatment of Patients with Small Cell Lung Cancer1
Principal Investigator: Monica Bertagnolli, MD, Alliance Foundation Trials
Description: For this open-label phase 2 study (ClinicalTrials.gov Identifier: NCT02963090), researchers are comparing the effectiveness of pembrolizumab with that of topotecan among patients with small-cell lung cancer (SCLC) who fail first-line treatment with etoposide plus a platinum agent.
Patients will be randomly assigned 2:1 to receive intravenous (IV) topotecan 1.25 mg/m2 on days 1 to 5 every 3 weeks, or IV pembrolizumab 200 mg on day 1 of every 3 weeks; patients will be assessed every 6 weeks via radiographic imaging to evaluate treatment response. Patients receiving topotecan who experience disease progression will be allowed to cross over to the pembrolizumab group.
The primary outcome is progression-free survival. Follow-up is set to be for 30 months.
The estimated study enrollment is 98 patients.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02963090.
Status: Open and recruiting patients as of February 21, 2018.
This study is sponsored by Alliance Foundation Trials, LLC.
- ClinicalTrials.gov. Pembrolizumab vs topotecan in patients with small cell lung cancer. NCT02963090. https://clinicaltrials.gov/ct2/show/NCT02963090. Accessed February 21, 2018.