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Checkpoint Inhibitor

M7824 + Chemotherapy for Small Cell Lung Cancer

Phase 1 & 2
Recruiting
Led By Anish Thomas, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically or cytologically confirmed SCLC or extrapulmonary small cell cancers
Subjects with relapsed SCLC with tumor progression on or after at least one prior chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of the trial until disease progresion of death.
Awards & highlights

Study Summary

This trial is testing a new cancer treatment consisting of an immunotherapy drug and either topotecan or temozolomide (a chemotherapy drug) for people with small cell lung cancer that has progressed after initial treatment. The objective is to determine the efficacy of the new treatment using objective response rate.

Who is the study for?
This trial is for adults over 18 with relapsed Small Cell Lung Cancer (SCLC) who've had at least one chemotherapy treatment and whose cancer has progressed after immunotherapy. They should not have had chemo, major surgery within the last 2 weeks, or radiotherapy in the past 24 hours. Participants need to be physically capable of undergoing treatment (ECOG ≤2), have measurable disease, and proper organ function.Check my eligibility
What is being tested?
The study tests M7824 alone or combined with Topotecan or Temozolomide in patients with SCLC that's come back after previous treatments. It aims to see if adding M7824 to standard drugs can better control cancer growth. Patients are divided into three groups: one receives only M7824; another gets M7824 plus Topotecan; and the third takes M7824 with Temozolomide.See study design
What are the potential side effects?
Possible side effects include typical reactions seen with immune checkpoint inhibitors like fatigue, skin reactions, inflammation of organs such as lungs or intestines, hormonal gland problems, infusion-related reactions and potential worsening of autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as small cell lung cancer or related type.
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My small cell lung cancer has worsened after at least one chemotherapy treatment.
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My small cell lung cancer worsened after immunotherapy.
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I need assistance with my daily activities.
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My organs and bone marrow are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days (arm b) or 28 days (arm c)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days (arm b) or 28 days (arm c) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy
Secondary outcome measures
PFS, DOR and OS
Safety

Side effects data

From 2020 Phase 3 trial • 444 Patients • NCT03061812
58%
ANAEMIA
39%
NEUTROPENIA
35%
THROMBOCYTOPENIA
31%
NAUSEA
27%
FATIGUE
27%
DECREASED APPETITE
22%
CONSTIPATION
19%
DYSPNOEA
19%
LEUKOPENIA
19%
DIARRHOEA
16%
ALOPECIA
16%
ASTHENIA
13%
VOMITING
13%
MALIGNANT NEOPLASM PROGRESSION
12%
COUGH
11%
EPISTAXIS
10%
HYPOKALAEMIA
9%
NEUTROPHIL COUNT DECREASED
9%
BACK PAIN
9%
OEDEMA PERIPHERAL
9%
FEBRILE NEUTROPENIA
9%
ABDOMINAL PAIN
9%
HEADACHE
8%
ARTHRALGIA
7%
INSOMNIA
6%
URINARY TRACT INFECTION
5%
PARAESTHESIA
5%
PLATELET COUNT DECREASED
5%
DYSGEUSIA
5%
WEIGHT DECREASED
5%
PYREXIA
5%
MYALGIA
5%
PNEUMONIA
5%
GENERAL PHYSICAL HEALTH DETERIORATION
4%
PLEURAL EFFUSION
3%
HYPOTENSION
3%
CHEST PAIN
2%
INFLUENZA
2%
HYPOXIA
2%
HYPOALBUMINAEMIA
2%
ASPARTATE AMINOTRANSFERASE INCREASED
2%
PANCYTOPENIA
2%
HYPONATRAEMIA
2%
CONFUSIONAL STATE
2%
SEPSIS
2%
NEOPLASM PROGRESSION
2%
PERICARDIAL EFFUSION
1%
MUSCULAR WEAKNESS
1%
RENAL FAILURE
1%
RASH
1%
VERTIGO
1%
SMALL CELL LUNG CANCER
1%
CERVICAL CORD COMPRESSION
1%
NEUTROPENIC SEPSIS
1%
ORCHITIS
1%
CANDIDA INFECTION
1%
HEPATIC FAILURE
1%
HAEMATOTOXICITY
1%
LUNG NEOPLASM MALIGNANT
1%
TUMOUR PAIN
1%
PNEUMOTHORAX
1%
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
1%
BRONCHITIS
1%
LUNG ABSCESS
1%
ALANINE AMINOTRANSFERASE INCREASED
1%
GASTROENTERITIS
1%
CHOLANGITIS
1%
HYPERGLYCAEMIA
1%
ACUTE MYOCARDIAL INFARCTION
1%
CANCER PAIN
1%
MEMORY IMPAIRMENT
1%
NERVOUS SYSTEM DISORDER
1%
SYNCOPE
1%
ANGINA UNSTABLE
1%
LUNG NEOPLASM
1%
APLASIA
1%
GASTROINTESTINAL HAEMORRHAGE
1%
STAPHYLOCOCCAL INFECTION
1%
FALL
1%
GENERAL PHYSICAL CONDITION ABNORMAL
1%
BONE PAIN
1%
MALIGNANT NEOPLASM OF SPINAL CORD
1%
INTRACRANIAL PRESSURE INCREASED
1%
MENTAL STATUS CHANGES
1%
PNEUMONIA ASPIRATION
1%
RESPIRATORY FAILURE
1%
SUPERIOR VENA CAVA SYNDROME
1%
DISEASE PROGRESSION
1%
EMBOLIC STROKE
1%
NON-CARDIAC CHEST PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topotecan
Rovalpituzumab Tesirine

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C/M7824 plus temozolomideExperimental Treatment2 Interventions
M7824 (IV) days 1 and 15 plus temozolomide (oral) on days 1-5 of a 28-day cycle. At least 6 subjects with SCLC to receive M7824 plus temozolomide to determine safety. 4 more SCLC patients enrolled at initial or lower dose for efficacy. If efficacious, an additional 12 SCLC subjects enrolled. After the 6 safety SCLC cohort, subjects with extrapulmonary small cell cancers will be enrolled.
Group II: Arm B/M7824 plus topotecanExperimental Treatment2 Interventions
M7824 (IV) on day 1 plus topotecan (IV) on days 1-5 of a 21-day cycle. At least 6 subjects to receive M7824 plus topotecan to determine safety. 4 more patients enrolled at initial or lower dose for efficacy. If efficacious, an additional 12 subjects enrolled.
Group III: Arm A/M7824 MonotherapyExperimental Treatment2 Interventions
M7824 (IV) monotherapy once every 21 days on a 21-day cycle. If patients have progressive disease on arm A, they may receive combination therapy of M7824 and Temozolomide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M7824
2020
Completed Phase 2
~350
Topotecan
2017
Completed Phase 3
~2400
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,678 Previous Clinical Trials
40,927,015 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
732 Total Patients Enrolled

Media Library

M7824 (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03554473 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: Arm B/M7824 plus topotecan, Arm C/M7824 plus temozolomide, Arm A/M7824 Monotherapy
Small Cell Lung Cancer Clinical Trial 2023: M7824 Highlights & Side Effects. Trial Name: NCT03554473 — Phase 1 & 2
M7824 (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03554473 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a similar experiment been conducted before?

"Since 2002, Topotecan has been investigated. The promising drug first underwent a clinical trial in the same year, sponsored by Schering-Plough and involving 60 patients. Subsequently obtaining Phase 2 approval, current research for Topotecan is underway across 1186 cities and 45 countries with 264 active studies available globally."

Answered by AI

What is the current enrollment capacity of this medical experiment?

"Confirmed. Clinicaltrials.gov records demonstrate that, since its initial posting on 9/11/2018, this clinical trial is actively searching for participants. 67 individuals are expected to be recruited from one medical centre."

Answered by AI

Is there any availability to join the research protocol?

"Affirmative. According to clinicaltrials.gov, this medical trial is engaging in active recruitment and was initially posted on September 11th 2018. Its latest update occurred on October 4th 2022 with a goal of 67 participants across 1 site."

Answered by AI

What other experiments have been conducted to explore the efficacy of Topotecan?

"Currently, there are 264 clinical trials being conducted to research topotecan. Of these experiments, 41 have progressed to Phase 3 and the largest concentration of studies can be found in Houston, Texas. However, 7832 medical centres across the globe are running similar investigations into this treatment's efficacy."

Answered by AI

In what clinical contexts is Topotecan usually administered?

"Topotecan is usually associated with nitrosourea treatment, but it has been found to have efficacy in treating acute and refractory leukaemia, myelocytic disorders, advanced directives, and even select cases of cutaneous T-cell lymphoma."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers
2018. "M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03554473.
All > Lung Cancer Baltimore > Small Cell Lung Cancer
~8 spots leftby Jan 2025
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