Extrapulmonary Lung Cancer clinical trials

Topotecan Plus M6620 (VX-970) vs. Topotecan Alone in People With Relapsed Small-Cell Lung Cancer

Background: Small cell cancers are aggressive and grow fast. They can appear in the lungs and in other parts of the body. These tumors often don t respond well to treatment if they come back after chemotherapy. Treatment with two drugs combined may be able to help. Objective: To compare M6620 plus topotecan to topotecan alone in people with small cell lung cancer (SCLC). Also, to test the effects of M6620 plus topotecan in people with small cell cancer outside the lungs. Eligibility: People ages 18 and older with relapsed SCLC or small cell cancer outside the lungs Design: Participants will be screened with: Physical exam Blood and heart tests CT scan Tumor biopsy: This is mandatory for participants with SCLC. It is optional for those with small cell cancer outside the lungs. Participants with SCLC will be randomly assigned to 1 of 2 groups: to receive either M6620 and topotecan or topotecan alone. Outside of the lungs small cell cancer participants will be assigned to receive both drugs. Participants will receive treatment in 21-day cycles. They will get topotecan through a vein in the arm on days 1 5 of each cycle. Some participants also will receive M6620 through a vein in the arm on days 2 and 5 of each cycle. Participants will have blood tests and physical exams every cycle. They will have CT scans every 6 weeks. Participants will continue treatment as long as their cancer does not get worse and they can handle the side effects. After treatment, participants will have visits every 3 months. Visits will include blood tests and CT scans. Patients randomized 2:1 ie 2 times more likely to get the combination vs. single drug Patients who receive single drug may receive the combination at the time of progression