M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

September 11, 2018

Primary Completion Date

June 1, 2022

Study Completion Date

March 13, 2025

Conditions
Carcinoma, Small CellLung CancerSmall Cell Lung Cancer
Interventions
DRUG

M7824

Arm A \& B: 2400mg intravenous (IV) over up to 120 minutes every 3 weeks on a 3-week cycle. Arm C: 1200 mg IV over 1 hour every 2 weeks on a 4-week cycle.

DRUG

Topotecan

Arm B: 1 mg/m(2) intravenous (IV) over 30 minutes days 1-5 on a 3-week cycle.

DRUG

Temozolomide

Arm C and progressive disease patients on Arm A: 200 mg/m(2) by mouth (PO) days 1-5 on a 4-week cycle.

DIAGNOSTIC_TEST

EKG

Screening and baseline.

DIAGNOSTIC_TEST

CT scan

Computed tomography (CT) scan performed at Screening and after every 2 cycles (6 weeks) per Study Calendar for Arm B 3.5.2, Arm B 3.5.2, and/or Arm C 3.5.3 as applicable.

DIAGNOSTIC_TEST

PET scan

Positron emission tomography (PET) not mandatory - If a computed tomography (CT) scan is not sufficient to assess response, a PET scan may be added per Study Calendar for Arm A 3.5.1, Arm B 3.5.2, and/or Arm C 3.5.3 as applicable.

DRUG

Acetaminophen

For infusion related reaction, 500-1000 mg by mouth (PO) prior to infusion.

DRUG

Antihistamines

As medically indicated.

DRUG

Diphenhydramine

For infusion related reaction, 50 mg by mouth (PO) prior to infusion.

DRUG

Dexamethasone

As medically indicated.

DRUG

Epinephrine

As medically indicated.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT03554473 - M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers | Biotech Hunter | Biotech Hunter