Actively Recruiting
Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy
Led by M.D. Anderson Cancer Center · Updated on 2026-02-19
51
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial finds out the effect of local consolidative therapy and durvalumab in treating patients with stage III non-small cell lung cancer that has 3 or fewer lesions of progression (oligoprogressive) and greater than 3 lesions of progression (polyprogressive) after chemoradiation and anti-PD-l1 therapy. Local consolidative therapy, such as surgery and/or radiation, after initial treatment may kill any remaining tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving local consolidative therapy and durvalumab may help to control the disease.
CONDITIONS
Official Title
Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Diagnosed with stage III non-small cell lung cancer (NSCLC) as per AJCC 7th or 8th edition
- Received standard chemoradiation followed by durvalumab therapy with progressive or persistent disease
- For lung adenocarcinoma, no EGFR sensitizing mutations, ALK fusion, ROS1 rearrangements, RET fusions, or MET exon 14 skipping mutations
- Oligoprogressive disease (3 or fewer progressing lesions) for Cohort A
- Polyprogressive disease (more than 3 progressing lesions) for Cohort B
- Candidate for radiation therapy to at least one lesion
- Tumor assessment (CT with contrast or PET-CT and brain MRI) performed within 28 days prior to study entry
- Age 18 years or older
- ECOG performance status of 0 or 1
- Body weight over 30 kg
- Hemoglobin level of at least 9.0 g/dL
- Platelet count at least 75 x 10^9/L
- Serum bilirubin less than or equal to 1.5 times the institutional upper limit of normal, except patients with Gilbert's syndrome
- AST/ALT less than or equal to 2.5 times the institutional upper limit of normal, or up to 5 times if liver metastases present
- Creatinine clearance greater than 15 mL/min
- Willing and able to comply with study treatment and visits
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Rapid progression on PACIFIC regimen defined as progression on first 3-month scan after durvalumab post-chemoradiation
- Treated with anti-PD-(L)1 therapy other than durvalumab
- Participation in another investigational clinical study within last 4 weeks
- Concurrent enrollment in interventional clinical study other than observational
- Received anticancer therapy within 28 days prior to study drug, except durvalumab
- Unresolved toxicities grade 2 or higher from prior anticancer therapy, except alopecia, vitiligo, and specified lab values
- Concurrent chemotherapy or investigational therapy outside protocol except for polyprogression cohort chemotherapy
- Major surgery within 28 days before study drug, except palliative local surgery
- History of allogenic organ transplantation
- Active or prior autoimmune or inflammatory disorders except specified exceptions
- Uncontrolled illness including infection, heart failure, uncontrolled hypertension, arrhythmia, interstitial lung disease, serious gastrointestinal conditions, psychiatric illness limiting compliance
- History of another primary malignancy except certain treated cancers without active disease for 3 or more years
- History of leptomeningeal carcinomatosis
- Untreated or unstable brain metastases
- QTcF interval of 470 ms or greater
- History of active primary immunodeficiency
- Active infections including tuberculosis, hepatitis B, unresolved hepatitis C
- Use of immunosuppressive medication within 14 days before durvalumab except certain steroids
- Receipt of live attenuated vaccine within 30 days prior to study drug
- Pregnant or breastfeeding females and patients unwilling to use effective birth control
- Known allergy to study drugs or excipients
- Prior anti-PD-1, PD-L1 or CTLA-4 therapy with certain adverse events or ongoing immunosuppression
- Investigator judgment of unsuitability or likely non-compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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