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.

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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.


  1. ClinicalTrials.gov. Pembrolizumab vs topotecan in patients with small cell lung cancer. NCT02963090. https://clinicaltrials.gov/ct2/show/NCT02963090. Accessed February 21, 2018.