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Checkpoint Inhibitor

Radiotherapy + Immunotherapy/PARP Inhibitor for Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Alberto A Chiappori, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have small cell lung cancer, documented by histology or cytology from brushing, washing, fine needle aspiration or core biopsy from a defined lesion, but not from sputum cytology alone. No mixed histologies allowed
Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
Must not have
Participants who have received any previous treatment with a Poly ADP Ribose Polymerase (PARP) inhibitor, including olaparib
History of allergy or hypersensitivity to any of the study drugs or study drug components
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Summary

This trial is testing whether adding immunotherapy or a PARP inhibitor to thoracic radiation therapy is safe and effective in people with ES-SCLC who have responded to first-line platinum-based chemotherapy.

Who is the study for?
This trial is for adults with Small Cell Lung Cancer who've had a positive response to first-line platinum-based chemotherapy. They must be willing to use effective contraception, have no severe allergies to the study drugs, and not have received certain prior treatments that could affect results. Participants should be in good enough health with proper organ function and an expected lifespan of at least 16 weeks.Check my eligibility
What is being tested?
The trial tests thoracic radiation followed by durvalumab alone or combined with tremelimumab or olaparib in patients who responded well to initial chemo. It's randomized, meaning participants are put into groups by chance, and it compares the safety and effectiveness of these treatment combinations.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, digestive issues like nausea or diarrhea, blood cell count changes which can increase infection risk, liver or kidney function problems due to medication toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer diagnosis was confirmed through a biopsy, not just a sputum test.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I weigh more than 30 kg.
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My small cell lung cancer was diagnosed at an extensive stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never been treated with PARP inhibitors like olaparib.
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I am not allergic to any of the drugs or their components used in this study.
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I have not had radiation therapy to the chest area before.
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I cannot have radiotherapy due to a genetic condition.
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I have cancer cells in the fluid around my brain and spinal cord.
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I have or had lung inflammation treated with steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Unacceptable Serious Adverse Events (SAEs)
Phase IB: Progression Free Survival
Secondary outcome measures
Median Progression Free Survival
Overall Survival

Side effects data

From 2013 Phase 2 trial • 90 Patients • NCT01000480
48%
Nausea
30%
Dysphagia
26%
Oesophagitis
24%
Constipation
20%
Asthenia
19%
Neutropenia
16%
Fatigue
16%
Cough
14%
Dyspnoea
13%
Leukopenia
12%
Vomiting
11%
Stomatitis
11%
Radiation oesophagitis
11%
Radiation skin injury
9%
Diarrhoea
9%
Pyrexia
9%
Decreased appetite
8%
Dyspepsia
8%
Haemoglobin decreased
8%
Anaemia
8%
Dizziness
8%
Dysgeusia
7%
Conjunctivitis
7%
Back pain
7%
Rash
7%
Lymphopenia
7%
Vertigo
6%
White blood cell count decreased
6%
Neutrophil count decreased
6%
Chest pain
6%
Thrombocytopenia
4%
Pulmonary embolism
2%
General physical health deterioration
2%
Dehydration
1%
Hypoacusis
1%
Enteritis
1%
Gastritis erosive
1%
Device related infection
1%
Pneumonia
1%
Septic shock
1%
Hyponatraemia
1%
Cerebrovascular accident
1%
Paraesthesia
1%
Syncope
1%
Renal impairment
1%
Urinary retention
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pemetrexed, Cisplatin, and Thoracic Radiotherapy

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Thoracic Radiotherapy plus Durvalumab and OlaparibExperimental Treatment3 Interventions
Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks and 300 mg orally of Olaparib twice a day
Group II: Thoracic Radiotherapy plus Durvalumab and 75mg TremelimumabExperimental Treatment3 Interventions
Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks for up to 4 doses and 75mg intravenously of Tremelimumab every 4 weeks for up to 4 doses
Group III: Thoracic Radiotherapy plus Durvalumab and 300mg TremelimumabExperimental Treatment3 Interventions
Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks and 300 mg Tremelimumab IV x 1 (single dose)
Group IV: Thoracic Radiotherapy plus DurvalumabActive Control1 Intervention
This Arm is a standard of care Arm. Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks for up to 13 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thoracic Radiotherapy
2003
Completed Phase 2
~110
Tremelimumab
2017
Completed Phase 2
~3130
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
549 Previous Clinical Trials
135,685 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,624,574 Total Patients Enrolled
Alberto A Chiappori, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03923270 — Phase 1
Small Cell Lung Cancer Research Study Groups: Thoracic Radiotherapy plus Durvalumab, Thoracic Radiotherapy plus Durvalumab and 75mg Tremelimumab, Thoracic Radiotherapy plus Durvalumab and Olaparib, Thoracic Radiotherapy plus Durvalumab and 300mg Tremelimumab
Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03923270 — Phase 1
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03923270 — Phase 1
~4 spots leftby Jul 2025
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