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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
Male participants must be willing to refrain from sperm donation during the study and for at least 180 days after the last dose of durvalumab combination therapy, 90 days after the last dose of durvalumab or olaparib monotherapy
Adequate renal function as defined per protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Study 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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I agree not to donate sperm during and up to 6 months after the study if I receive combination therapy, or 3 months after if on monotherapy.
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My kidney function is within normal ranges.
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I can provide a sample of my tumor for testing.
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My small cell lung cancer was diagnosed at an extensive stage.
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My lung cancer diagnosis was confirmed through a biopsy, not just a sputum test.
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I've had 3-6 rounds of specific chemo for my cancer and it hasn't gotten worse.
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I agree to use highly effective birth control during and after the study.
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I do not have an active infection like TB, hepatitis B, or hepatitis C.
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My liver is functioning well.
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I will start the study treatment within 60 days after my last platinum-based chemotherapy.
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I weigh more than 30 kg.
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I am fully active or restricted in physically strenuous activity but can do light work.

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%
Enteritis
1%
Hypoacusis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3380
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
535 Previous Clinical Trials
134,536 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,224 Previous Clinical Trials
288,418,074 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 and 300mg Tremelimumab, Thoracic Radiotherapy plus Durvalumab and Olaparib, Thoracic Radiotherapy plus Durvalumab, Thoracic Radiotherapy plus Durvalumab and 75mg 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

Frequently Asked Questions

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

How many participants is the clinical trial recruiting?

"Affirmative. Clinicaltrials.gov records demonstrate that this medical trial, which was first posted on June 6th 2019, is actively recruiting participants. Approximately 54 individuals must be sourced from a single centre."

Answered by AI

In what cases is Thoracic Radiotherapy typically prescribed?

"Thoracic Radiotherapy is regularly utilized to treat this ailment, and has been discovered to be beneficial for pharmacotherapy, peritoneal cancer, as well as the implementation of advance directives."

Answered by AI

Is there precedent for Thoracic Radiotherapy research in the medical community?

"Presently, 489 Thoracic Radiotherapy trials are underway with 75 Phase 3 clinical studies. Although most of these investigations are in Houston, Texas, there are 2099 other facilities conducting related research."

Answered by AI

Are there any current opportunities to partake in this test?

"Indeed, the clinical trial is open for enrolment. The first posting was on June 6th 2019 and most recently updated September 30th 2022. This research seeks 54 participants from a single medical site."

Answered by AI

Has Thoracic Radiotherapy been given the green light by the Food and Drug Administration?

"Our assessment at Power assigns Thoracic Radiotherapy a score of 1, as there is limited information available on the treatment's efficacy and safety from Phase 1 trials."

Answered by AI

Is this an unprecedented research endeavor?

"Currently, there exist 489 ongoing Thoracic Radiotherapy trials across 1847 cities and 65 countries. This therapy initially debuted in 2005 under an AstraZeneca-sponsored Phase 1 drug approval study which recruited 98 participants. Since then, 184 such studies have been successfully concluded."

Answered by AI
~4 spots leftby Feb 2025