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Checkpoint Inhibitor
Chemoradiotherapy + Immunotherapy for Non-Small Cell Lung Cancer
Phase 3
Recruiting
Led By Maximilian Diehn, MD
Research Sponsored by Joel Neal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aspartate aminotransferase (AST) (SGOT)/Alanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be ≤ 5 x ULN
Histologically or cytologically documented NSCLC with locally advanced, unresectable (stage III) disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if adding chemotherapy to the standard treatment can lower the number of cancer cells in the blood.
Who is the study for?
Adults over 18 with stage III NSCLC who've had two doses of durvalumab after chemo and radiation without disease progression. They must have good blood counts, organ function, a life expectancy of at least 12 weeks, and an ECOG status of 0 or 1. Not eligible if pregnant/breastfeeding without effective birth control, on other clinical trials within the last month, have certain autoimmune diseases or prior severe reactions to trial drugs.Check my eligibility
What is being tested?
The study is testing if adding more chemotherapy to standard treatment (durvalumab) can reduce circulating cancer cells in the blood for those with stage III NSCLC. It involves using a ctDNA Surveillance Kit to monitor response and may include additional consolidation chemotherapy as part of the protocol.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medications used (durvalumab, carboplatin, pemetrexed or paclitaxel), immune-related issues like inflammation in various organs due to immunotherapy (durvalumab), typical chemo side effects such as fatigue, nausea/vomiting, low blood cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function tests are within the required range.
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My lung cancer is at an advanced stage and cannot be removed by surgery.
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I have had, or will have, 2 doses of durvalumab.
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I've had at least 2 rounds of platinum chemotherapy and radiation of 60 Gy or more without my cancer getting worse.
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I am fully active or can carry out light work.
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I weigh more than 30kg.
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My kidney function, measured by creatinine clearance, is good.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ctDNA Level Following Chemotherapy
Secondary outcome measures
Durvalumab and Tremelimumab related Adverse Events (Cohort 1 MRD+ only)
Overall Survival (OS)
Presence of Detectable ctDNA Following Chemotherapy
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 minimal residual disease negative (MRD )Experimental Treatment2 Interventions
Subjects with undetectable ctDNA at study enrollment will receive standard of care durvalumab (10 mg/kg every 2 weeks, or equivalent, for 1 year). If subjects in Cohort 2 MRD progress prior to close of study, blood will be drawn for ctDNA testing.
Group II: Cohort 1 minimal residual disease positive (MRD+)Experimental Treatment7 Interventions
Subjects with detectable ctDNA will receive 4 cycles of platinum doublet chemotherapy [carboplatin/pemetrexed], tremelimumab (75 mg IV every 21 days) and durvalumab (1500 mg IV every 21 days), except subjects with squamous cell carcinoma histology will receive carboplatin/paclitaxel. Subjects will be evaluated with PET/CT and/or computed tomography (CT) thorax every 12 weeks. Following ctDNA evaluation, in the absence of progression or toxicity, subject will continue with durvalumab to complete 1 year of treatment as standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3380
Platinum
Not yet FDA approved
Durvalumab
FDA approved
Carboplatin
FDA approved
Glutamic acid
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
Joel NealLead Sponsor
3 Previous Clinical Trials
58 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,397 Previous Clinical Trials
17,342,307 Total Patients Enrolled
Maximilian DiehnLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have nerve damage that affects my daily activities.You are expected to live for at least 12 weeks.My liver function tests are within the required range.My lung cancer is at an advanced stage and cannot be removed by surgery.Your body has enough infection-fighting white blood cells.I am undergoing or will undergo chemoradiation for advanced lung cancer.I am currently being treated for another type of cancer.I don't have active autoimmune or inflammatory disorders that could affect my treatment.I have had, or will have, 2 doses of durvalumab.I've had at least 2 rounds of platinum chemotherapy and radiation of 60 Gy or more without my cancer getting worse.I am fully active or can carry out light work.I weigh more than 30kg.Your hemoglobin level is at least 9.0 grams per deciliter.I haven't taken strong immune-suppressing drugs in the last 2 weeks, except for low-dose steroids or those for radiation side effects.I do not have an active infection like TB or hepatitis, and I haven't had a live vaccine recently.I am not pregnant, breastfeeding, and I agree to use effective birth control.My lung cancer is a mix of small cell and non-small cell types.I have had severe side effects from previous immunotherapy.I haven't had major surgery in the last 4 weeks, except for getting a vascular access.I am 18 years old or older.You have a mental illness or social situation that may make it hard to follow the study rules, increase the chance of side effects, or make it difficult to give permission to join the study.If you have a pre-existing condition, like hearing loss, that won't get worse with the study drug, you may join after talking to the study doctor.Your platelet count is higher than 75 x 10^9 per liter (100,000 per cubic millimeter).I do not have any serious ongoing illnesses that are not under control.I am open to receiving specific chemotherapy if needed, as outlined in the study.My kidney function, measured by creatinine clearance, is good.Your bilirubin levels in the blood should not be higher than 1.5 times the normal limit, unless you have Gilbert's syndrome and your doctor agrees you can still participate.I don't have major side effects from previous cancer treatments, except for hair loss or skin changes.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 minimal residual disease positive (MRD+)
- Group 2: Cohort 2 minimal residual disease negative (MRD )
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 patients presently being enrolled in this medical study?
"Yes, the trial is still recruiting according to the information on clinicaltrials.gov. This particular study was posted on 8/25/2021 and was updated 8/31/2021. They are looking for 48 patients from 1 site."
Answered by AI
Is this a large-scale study or a smaller one?
"Yes, this is an ongoing trial that is currently seeking participants. According to the information available on clinicaltrials.gov, the trial was first posted on 8/25/2021, and the most recent update was on 8/31/2021. They are looking for 48 participants total, at 1 site."
Answered by AI
For what purpose is Durvalumab most often prescribed?
"Durvalumab can be used as a therapeutic intervention for patients suffering from malignant neoplasms, locally advanced nonsquamous non-small cell lung cancer, and conditioning regimens for allogeneic stem cell transplantation therapy."
Answered by AI
Is Durvalumab known to have any negative health effects?
"Power has given Durvalumab a safety score of 3. This is based on the fact that it is a Phase 3 trial, which suggests that not only is there some evidence of its efficacy, but also that there is repeated evidence of its safety."
Answered by AI
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