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Platinum-based Chemotherapy

SBRT + Chemoimmunotherapy for Small Cell Lung Cancer

Phase 1

Recruiting

Led By Taofeek Owonikoko, MD, PhD

Research Sponsored by Taofeek Owonikoko

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome

Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

Study Summary

This trial is studying the safety of combining different types of cancer treatment, including immunotherapy, chemotherapy, and radiation therapy, to see if it is effective in treating small cell lung cancer.

Who is the study for?

This trial is for adults over 18 with extensive stage small cell lung cancer (ES-SCLC) who haven't had much treatment. They should be in good physical condition, able to follow the study plan, and not pregnant or breastfeeding. Participants need functioning organs and no serious illnesses that could interfere with the study.Check my eligibility

What is being tested?

The trial tests adaptive SBRT combined with durvalumab immunotherapy and platinum-based chemo (cisplatin or carboplatin) plus etoposide on patients with ES-SCLC. It aims to see how safe this combination is for treating this type of lung cancer.See study design

What are the potential side effects?

Possible side effects include typical chemotherapy issues like nausea, fatigue, blood count changes; immunotherapy-related inflammation; radiotherapy skin reactions; organ function problems; allergic reactions to drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bilirubin levels are within the normal range, except I have Gilbert's syndrome.

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I am willing and able to follow the study's treatment plan and attend all visits.

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I have small cell lung cancer and haven't received treatment, or only had one round of chemotherapy.

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I am not pregnant or cannot become pregnant.

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My kidney function, measured by creatinine levels, is normal or adequately high.

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I am fully active or can carry out light work.

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My lung cancer diagnosis was confirmed through lab tests.

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I am older than 18 years.

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My body weight is over 30 kg.

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My organs and bone marrow are functioning well.

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My condition was diagnosed at an advanced stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-related adverse events (AEs)

Secondary outcome measures

Objective Response Rate (ORR)

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Treatment ArmExperimental Treatment5 Interventions

Eligible patients will complete 2 cycles of study treatment with durvalumab, platinum (cisplatin or carboplatin per investigator choice), and etoposide. Patients will then undergo standard of care restaging imaging. Those patients who have a partial or complete response will continue with combination systemic therapy, without additional intervention. In patients with less than a partial response (stable disease or progressive disease), SBRT will be given prior to cycle 3 of systemic therapy. The radiotherapy will be given in 5 fractions of 6 Gy to the primary tumor site. See study schema. Patients who undergo SBRT will resume systemic therapy within 2 weeks of completing SBRT and the interval between cycle 2 and cycle 3 should not exceed 6 weeks. Subsequent restaging imaging will continue as per standard of care. All patients will continue maintenance therapy with durvalumab until confirmed progressive disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiotherapy

2017

Completed Phase 2

~220

Platinum

Not yet FDA approved

Platinum

Not yet FDA approved