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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
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 • NCT0100048048%
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
~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
542 Previous Clinical Trials
135,467 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,761 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been treated with PARP inhibitors like olaparib.You have tested positive for HIV or have a history of AIDS.I am not allergic to any of the drugs or their components used in this study.I do not have severe autoimmune or inflammatory disorders that need constant treatment.I will start the study treatment within 60 days after my last platinum-based chemotherapy.I have previously received immunotherapy targeting specific cancer pathways but stopped before joining this trial.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.I can provide a sample of my tumor for testing.I have not had radiation therapy to the chest area before.I have recovered from major surgery or significant injury for at least 14 days before starting chest radiation.Your bone marrow is working properly based on recent tests.My lung cancer diagnosis was confirmed through a biopsy, not just a sputum test.I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.I cannot have radiotherapy due to a genetic condition.Any side effects from my previous cancer treatments have mostly gone away.I am fully active or restricted in physically strenuous activity but can do light work.I weigh more than 30 kg.I had brain metastases but am now stable and not on high doses of steroids.I agree to use highly effective birth control during and after the study.My kidney function is within normal ranges.My small cell lung cancer was diagnosed at an extensive stage.I do not have an active infection like TB, hepatitis B, or hepatitis C.I had cancer before, but it's been fully treated and controlled for over 2 years, with no ongoing treatments needed.I've had 3-6 rounds of specific chemo for my cancer and it hasn't gotten worse.My liver is functioning well.I have cancer cells in the fluid around my brain and spinal cord.I have or had lung inflammation treated with steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Thoracic Radiotherapy plus Durvalumab
- Group 2: Thoracic Radiotherapy plus Durvalumab and 75mg Tremelimumab
- Group 3: Thoracic Radiotherapy plus Durvalumab and Olaparib
- Group 4: Thoracic Radiotherapy plus Durvalumab and 300mg Tremelimumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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