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Platinum-based Chemotherapy
Radiation + Immunotherapy + Chemotherapy for Lung Cancer
Phase 2
Waitlist Available
Led By Gregory Vlacich, M.D, Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical AJCC stage IIIB with plans to be treated with concurrent chemoradiotherapy are eligible under specific criteria
Clinical AJCC stage IIB or IIIA (AJCC, 8th ed.) with plans to be treated with concurrent chemoradiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 61 days after start of chemoradiation through 2 years after the start of chemoradiation
Awards & highlights
Study Summary
This trial will test a new approach to treating lung cancer that uses both radiation and immunotherapy.
Who is the study for?
This trial is for adults with inoperable Stage IIB, IIIA, or select IIIB and IIIC non-small cell lung cancer (NSCLC). Participants may have had previous treatments but no prior thoracic radiation. They must meet certain blood and organ function standards, not be pregnant or breastfeeding, agree to use birth control, and cannot have severe autoimmune diseases or a history of certain lung conditions.Check my eligibility
What is being tested?
The study tests an advanced form of radiation therapy guided by magnetic resonance imaging (MRI) combined with chemotherapy drugs Carboplatin AUC and Paclitaxel followed by Durvalumab immunotherapy. It's a Phase II trial assessing the safety and effectiveness of this treatment sequence for NSCLC.See study design
What are the potential side effects?
Possible side effects include reactions related to MRI-guided radiation such as skin irritation or fatigue; chemotherapy-related issues like nausea, hair loss, low blood counts; and immune-related effects from Durvalumab including inflammation in organs or infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at stage IIIB and I am planning to undergo combined chemotherapy and radiation.
Select...
My cancer is at a specific stage and I will be treated with both chemotherapy and radiation.
Select...
My nerve damage is mild or not noticeable.
Select...
My condition cannot be treated with surgery or I have chosen not to undergo surgery.
Select...
My lung cancer diagnosis was confirmed through lab tests.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 61 days after start of chemoradiation through 2 years after the start of chemoradiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 61 days after start of chemoradiation through 2 years after the start of chemoradiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local control rate (Phase II only)
Regional control rate (Phase II only)
Safety lead-in only: Number of participants with dose limiting toxicities (DLTs)
Secondary outcome measures
Disease
Distant recurrence rate
Incidence of brain metastases
+5 moreSide effects data
From 2013 Phase 3 trial • 397 Patients • NCT0000405478%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Platelet count decreased
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Safety lead-in: Chemoradiation + DurvalumabExperimental Treatment5 Interventions
The first 6 patients enrolled on study will comprise the Safety Lead-In cohort and will be closely monitored for toxicity related specifically to the experimental chemoradiation portion of the study treatment. After these 6 patients have been enrolled, accrual will temporarily be suspended for a minimum of 6 months after completion of chemoradiation to allow for the evaluation of adverse events.
Patients will receive concurrent chemoradiation over the course of 3 weeks (15 fractions of radiation with online adaptive treatment planning at fractions 6, 9, and 12 and weekly carboplatin + paclitaxel). Four to 6 weeks after the end of chemoradiation, durvalumab immunotherapy will administered every 2 weeks or 4 weeks (timeline at the discretion of treating physician) for up to 12 months.
Group II: Phase II: Chemoradiation + DurvalumabExperimental Treatment5 Interventions
-Patients will receive concurrent chemoradiation over the course of 3 weeks (15 fractions of radiation with online adaptive treatment planning at fractions 6, 9, and 12 and weekly carboplatin + paclitaxel). Four to 6 weeks after the end of chemoradiation, durvalumab immunotherapy will administered every 2 weeks or 4 weeks (timeline at the discretion of the treating physician) for up to 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Carboplatin AUC
2016
Completed Phase 2
~30
Radiation therapy
2013
Completed Phase 3
~2850
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,683 Total Patients Enrolled
Gregory Vlacich, M.D, Ph.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another type of cancer or my cancer has spread.I have recovered from side effects of previous cancer treatments.My cancer is at a specific stage and I will be treated with both chemotherapy and radiation.My cancer is at stage IIIB and I am planning to undergo combined chemotherapy and radiation.I have had radiotherapy to my chest area before.Women who can have babies must have a negative pregnancy test within 2 weeks before joining the study.My breast cancer is at a specific advanced stage but has not spread to distant organs.My lung cancer has returned, but I haven't had chest radiation before, except for SBRT as allowed.I have had lung conditions like pulmonary fibrosis or pneumonia.My nerve damage is mild or not noticeable.You have a disease that can be measured or evaluated using a specific medical guideline called RECIST 1.1.I am receiving treatment for an autoimmune disease, with some exceptions.You cannot have an MRI scan for medical reasons.You have a serious, ongoing health problem.My condition cannot be treated with surgery or I have chosen not to undergo surgery.I take more than 10 mg of prednisone or its equivalent daily.Your blood test and other lab results need to be within certain ranges.My lung cancer diagnosis was confirmed through lab tests.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II: Chemoradiation + Durvalumab
- Group 2: Safety lead-in: Chemoradiation + Durvalumab
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.
Are there any openings for participants of this research currently available?
"According to clinicaltrials.gov, this research project is currently recruiting participants. It was initially introduced on June 20th 2019 and its details were most recently refreshed on June 27th 2022."
Answered by AI
What medical conditions are commonly treated with Radiation therapy?
"Radiation therapy is most commonly utilized to offer palliative care. In select cases, it can be used as the primary treatment for malignant peritoneal neoplasm and other diseases before they are treated with medication or surgery."
Answered by AI
To what extent has Radiation therapy been investigated in prior research?
"Currently, there are 1432 active Radiation therapy trials in progress with 365 of those studies at the Phase 3 level. Additionally, 74621 locations worldwide provide services for these experiments. Shanghai is a notable city as it has several clinical trial sites devoted to researching this particular treatment type."
Answered by AI
What adverse effects may arise from radiation-based treatments?
"Radiation therapy was rated a 2 on our internal scale, as there is currently no evidence of efficacy but some data indicating safety."
Answered by AI
How extensive is the current enrollment for this trial?
"Affirmative. According to clinicaltrials.gov, the trial is presently recruiting participants; it was first shared on 20th June 2019 and most recently updated on 27th June 2022. The study requires 27 patients from a single site."
Answered by AI
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