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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

Must not have

Subjects with symptomatic brain metastases

Subjects with evidence of severe or uncontrolled systemic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of the trial until disease progresion of death.

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that are causing symptoms.

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I do not have any severe or uncontrolled illnesses.

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I haven't taken immunosuppressive drugs in the last 7 days.

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I am allergic or react badly to topotecan or temozolomide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days (arm b) or 28 days (arm c)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy

Secondary study objectives

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%

DECREASED APPETITE

27%

FATIGUE

22%

CONSTIPATION

19%

LEUKOPENIA

19%

DIARRHOEA

19%

DYSPNOEA

16%

ASTHENIA

16%

ALOPECIA

13%

VOMITING

13%

MALIGNANT NEOPLASM PROGRESSION

12%

COUGH

11%

EPISTAXIS

10%

HYPOKALAEMIA

OEDEMA PERIPHERAL

HEADACHE

NEUTROPHIL COUNT DECREASED

BACK PAIN

FEBRILE NEUTROPENIA

ABDOMINAL PAIN

ARTHRALGIA

INSOMNIA

URINARY TRACT INFECTION

PNEUMONIA

PLATELET COUNT DECREASED

WEIGHT DECREASED

MYALGIA

DYSGEUSIA

PARAESTHESIA

PYREXIA

GENERAL PHYSICAL HEALTH DETERIORATION

PLEURAL EFFUSION

CHEST PAIN

HYPOTENSION

NEOPLASM PROGRESSION

HYPOXIA

SEPSIS

HYPONATRAEMIA

PERICARDIAL EFFUSION

HYPOALBUMINAEMIA

ASPARTATE AMINOTRANSFERASE INCREASED

INFLUENZA

PANCYTOPENIA

CONFUSIONAL STATE

BRONCHITIS

GENERAL PHYSICAL CONDITION ABNORMAL

CHOLANGITIS

TUMOUR PAIN

MEMORY IMPAIRMENT

ALANINE AMINOTRANSFERASE INCREASED

ORCHITIS

CANDIDA INFECTION

DISEASE PROGRESSION

BONE PAIN

SUPERIOR VENA CAVA SYNDROME

CERVICAL CORD COMPRESSION

MUSCULAR WEAKNESS

LUNG ABSCESS

VERTIGO

HEPATIC FAILURE

GASTROENTERITIS

FALL

SMALL CELL LUNG CANCER

HYPERGLYCAEMIA

EMBOLIC STROKE

NEUTROPENIC SEPSIS

RENAL FAILURE

STAPHYLOCOCCAL INFECTION

PNEUMOTHORAX

PNEUMONIA ASPIRATION

RESPIRATORY FAILURE

HAEMATOTOXICITY

INTRACRANIAL PRESSURE INCREASED

ACUTE MYOCARDIAL INFARCTION

ANGINA UNSTABLE

APLASIA

INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION

GASTROINTESTINAL HAEMORRHAGE

NON-CARDIAC CHEST PAIN

CANCER PAIN

LUNG NEOPLASM

LUNG NEOPLASM MALIGNANT

MALIGNANT NEOPLASM OF SPINAL CORD

NERVOUS SYSTEM DISORDER

SYNCOPE

MENTAL STATUS CHANGES

RASH

100%

80%

60%

40%

20%

Study treatment Arm

Topotecan

Rovalpituzumab Tesirine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2018

Completed Phase 3

~710

Topotecan

2017

Completed Phase 3

~2890