Clinical Trial TitleA phase 3, controlled, open-label, randomized study of RRx-001 administered sequentially with a platinum doublet or a platinum doublet in third-line or beyond small cell lung cancer (SCLC).
Clinical Trial Protocol Description:
The purpose of this research study is to test whether the drug RRx-001, a form of immunotherapy called a checkpoint inhibitor, has the potential to reduce or prevent resistance in small cell lung cancer (SCLC) tumors and to make the platinum chemotherapy treatment that was previously received have an effect again. This study will compare the impact of the addition of RRx-001 to platinum doublet chemotherapy versus platinum doublet chemotherapy alone.
Eligible participants will be randomized (like flipping a coin, 50/50 chance) to 1 of 2 groups or arms. Participants in Arm 1 will receive RRx-001 once a week for 3 weeks followed by up to 4 cycles of platinum doublet chemotherapy. Participants who have stable disease (or better) following their chemotherapy may go on to receive RRx-001 again (this time for 2 weeks) followed by 2 cycles of chemotherapy. These participants will continue to receive RRx-001 once a week for 2 weeks followed by 2 cycles of single agent platinum chemotherapy in a repeating pattern until their cancer gets worse. Participants in Arm 2 will receive the standard of care platinum doublet chemotherapy for up to 4 cycles. Participants in arm 2 whose cancer gets worse may “cross-over” to the Platinum Stacking Phase of Arm 1. If this occurs, participants will receive RRx-001 once a week for 2 weeks followed by 2 cycles of single agent platinum chemotherapy in a repeating pattern until their cancer gets worse.
ClinicalTrials.gov Identifier: NCT03699956
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are between 18 and 80 years of age at the time of study consent.
- Have a diagnosis of SCLC.
- Have had prior platinum treatment and treatment with a checkpoint inhibitor (unless contraindicated). Maintenance with a checkpoint inhibitor is NOT required.
You will be excluded from the study if any of the following criteria apply to you:
- Have symptomatic central nervous system metastases or neurologically unstable patients that are on increasing steroid dose.
- Have had greater than 10% weight loss in the last 6 weeks.
- Have had treatment of SCLC with any antineoplastic agent with the exception of steroids.
This is a partial list of inclusion and exclusion criteria.