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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
Body weight >30 kg
Adequate normal organ and marrow function as defined below:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
No Placebo-Only Group
Approved for 5 Other Conditions

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 body weight is over 30 kg.
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My organs and bone marrow are functioning well.
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I am fully active or can carry out light work.
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I am not pregnant or cannot become pregnant.
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My lung cancer diagnosis was confirmed through lab tests.
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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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My bilirubin levels are within the normal range, except I have Gilbert's syndrome.
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I am older than 18 years.
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My kidney function, measured by creatinine levels, is normal or adequately high.
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My condition was diagnosed at an advanced stage.

Timeline

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
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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

Find a Location

Who is running the clinical trial?

Taofeek OwonikokoLead Sponsor
1 Previous Clinical Trials
37 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,225 Previous Clinical Trials
288,418,079 Total Patients Enrolled
Taofeek Owonikoko, MD, PhDPrincipal InvestigatorUPMC Hillman Cancer Center
5 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05403723 — Phase 1
Small Cell Lung Cancer Research Study Groups: Single Treatment Arm
Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05403723 — Phase 1
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05403723 — Phase 1

Frequently Asked Questions

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

What percentage of people have serious side effects from Cisplatin?

"Cisplatin received a 1 because Phase 1 trials have limited data supporting both safety and efficacy."

Answered by AI
~24 spots leftby Feb 2025