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PD-L1 Inhibitor
Local Consolidative Therapy + Durvalumab for Lung Cancer
Phase 2
Recruiting
Led By Percy P Lee
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage III NSCLC (AJCC 7th and 8th edition) patients who received standard chemoradiation followed by durvalumab therapy with either progressive disease or persistent disease. Persistent disease defined as residual positron emission tomography (PET) avidity 6 months after completion of initial definitive therapy and confirmed with biopsy
Measured creatinine clearance (CL) > 15 mL/min or calculated creatinine CL > 15 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This triallooks at treating lung cancer with surgery/radiation & immunotherapy to control disease.
Who is the study for?
This trial is for adults with stage III non-small cell lung cancer who've had chemoradiation and anti-PD-L1 therapy but still have up to 3 progressing lesions (oligoprogressive) or more than 3 (polyprogressive). They should be fit for radiation, have a life expectancy of at least 12 weeks, and their major organs must function within certain limits. People with certain genetic mutations or unresolved severe side effects from previous treatments can't join.Check my eligibility
What is being tested?
The trial tests if adding local consolidative therapy (like surgery/radiation) to durvalumab immunotherapy helps control the disease better in patients whose cancer has progressed after initial treatments. It aims to see if this combination can kill remaining tumor cells and boost the immune system's ability to fight cancer.See study design
What are the potential side effects?
Durvalumab may cause immune-related reactions affecting various organs, fatigue, infusion reactions similar to allergic responses, digestive issues like diarrhea or colitis, skin problems such as rash or itching, hormonal imbalances, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stage III lung cancer, treated with chemoradiation and durvalumab, but my cancer either worsened or didn't fully respond.
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My kidney function, measured by creatinine clearance, is above 15 mL/min.
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I am a candidate for radiation therapy on at least one cancer lesion.
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My cancer has spread to more than 3 areas, but multiple chest lesions count as one.
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I am fully active or can carry out light work.
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My body weight is over 30 kg.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
OS2
Overall survival (OS)1
Quality of life questionnaires
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B (polyprogressive)Experimental Treatment9 Interventions
Patients undergo LCT consisting of radiation therapy and/or surgery, then receive durvalumab IV over 1 hour on day 1. Patients also receive one of the following chemotherapy options: carboplatin and paclitaxel on day 1, carboplatin on day 1 and nab-paclitaxel on days 1, 8, 15, or carboplatin on day 1 and gemcitabine on days 1 and 8. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with non-squamous histology receive pemetrexed on day 1 every 21 days for cycles 1-4, pemetrexed and durvalumab IV on day 1 every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Cohort A (oligoprogressive)Experimental Treatment4 Interventions
Patients undergo LCT consisting of radiation therapy and/or surgery, then receive durvalumab IV over 1 hour on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Durvalumab
FDA approved
Pemetrexed
FDA approved
Carboplatin
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,295 Total Patients Enrolled
Percy P LeePrincipal InvestigatorM.D. Anderson Cancer Center
Joe Y Chang, MD,MS,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any live vaccines in the last 30 days.I have stage III lung cancer, treated with chemoradiation and durvalumab, but my cancer either worsened or didn't fully respond.I have had cancer before, but it was a different type.You are expected to live for at least 12 more weeks.I have or had an autoimmune or inflammatory disorder.You have received an organ from another person through a transplant surgery.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.I have had cancer spread to the lining of my brain and spinal cord.My cancer has spread, but only to 3 or fewer places.My liver function tests are within the required range.My kidney function, measured by creatinine clearance, is above 15 mL/min.I am not on any cancer treatments except for those specified in this study or hormone therapy for non-cancer reasons.Your bilirubin levels in the blood are not too high, unless you have Gilbert's syndrome and your doctor says it's okay for you to join the study.My lung cancer does not have common mutations like EGFR, ALK, ROS1, RET, or MET.I last received cancer treatment less than 28 days ago, except for durvalumab.I am a candidate for radiation therapy on at least one cancer lesion.My cancer has spread to more than 3 areas, but multiple chest lesions count as one.I do not have any serious ongoing illnesses that would affect my participation in the study.I do not have an active infection and meet the specific conditions for hepatitis B and C.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I am willing and able to follow the study's treatment and visit schedule.I am not in another treatment study while starting this one, except for observational studies.Your heart's electrical activity measured by a special test shows an abnormal result.Your platelet count is at least 75 billion per liter of blood.I am fully active or can carry out light work.Your hemoglobin level is at least 9.0 grams per deciliter.My body weight is over 30 kg.You have a history of a weak immune system that is not working properly.I haven't taken immunosuppressive drugs in the last 14 days.I have previously received treatments targeting PD-1, PD-L1, or CTLA-4.I am not pregnant or breastfeeding and willing to use birth control during and up to 90 days after treatment.I've had recent scans (CT, PET-CT, MRI) of my chest, abdomen, pelvis, and brain.I have been treated with an anti-PD-(L)1 therapy, but not durvalumab.My cancer worsened quickly after starting treatment with durvalumab following chemoradiotherapy.I have nerve damage that affects my daily activities.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B (polyprogressive)
- Group 2: Cohort A (oligoprogressive)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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