Actively Recruiting
Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC
Led by Maximilian Diehn · Updated on 2026-05-04
48
Participants Needed
1
Research Sites
344 weeks
Total Duration
On this page
Sponsors
M
Maximilian Diehn
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test whether or not number of circulating cancer cells detected in the blood can be decreased the by combining the standard treatment (durvalumab) with Tremelimumab and additional chemotherapy
CONDITIONS
Official Title
Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed stage III locally-advanced unresectable NSCLC or locoregional recurrence after prior treatment
- Completed platinum-based chemotherapy and radiation therapy to all known tumor sites without disease progression
- Receiving consolidation Durvalumab after radiation and chemotherapy, with less than 32 weeks since first Durvalumab dose
- Able to receive further consolidation chemotherapy plus Durvalumab and Tremelimumab, but not already planned for additional systemic consolidation chemotherapy
- Pre-treatment tumor tissue or tumor DNA sample available for analysis
- Age 18 years or older
- Weight greater than 30 kg
- Life expectancy of at least 12 weeks
- ECOG Performance Status of 0 or 1
- Absolute neutrophil count above 1.0 x 10^9/L
- Platelets above 75 x 10^9/L
- Hemoglobin 9.0 g/dL or higher
- Measured creatinine clearance above 40 mL/min
- Serum bilirubin 1.5 times or less the upper limit of normal (exceptions for Gilbert's syndrome with physician approval)
- AST/ALT levels 2.5 times or less the institutional upper limit of normal unless liver metastases present (then up to 5 times)
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Participation in planning or conduct of this study
- Prior enrollment or randomization in this study
- Received investigational product in another clinical study
- Mixed small cell and non-small cell lung cancer histology
- History of another primary malignancy currently under active treatment (exceptions for adjuvant endocrine therapy)
- Use of immunosuppressive medication within 14 days before enrollment (with certain corticosteroid exceptions)
- Unresolved toxicity greater than Grade 2 from prior chemoradiation (with some exceptions)
- Prior Grade 3 or higher immune-related adverse event or unresolved Grade 1 or higher immune-related event limiting Durvalumab
- Major surgery within 4 weeks before study entry (excluding vascular access placement)
- Active or prior autoimmune or inflammatory disorders likely limiting Durvalumab use (with specific exceptions)
- History of primary immunodeficiency
- History of organ transplant needing immunosuppression
- Hypersensitivity to Carboplatin, Pemetrexed, Paclitaxel, or Nab-paclitaxel preventing re-administration
- Active serious infections including hepatitis B, hepatitis C, tuberculosis, or HIV
- Receipt of live attenuated vaccine within 30 days before first dose of chemotherapy and Durvalumab
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmias, interstitial lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding females or subjects not using effective birth control if of reproductive potential
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94304
Actively Recruiting
Research Team
R
Rene Bonilla
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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