Actively Recruiting
Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC
Led by Maximilian Diehn · Updated on 2026-05-04
48
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
M
Maximilian Diehn
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how combining the standard treatment durvalumab with tremelimumab and additional chemotherapy affects the number of circulating cancer cells in the blood of people with stage III non-small cell lung cancer (NSCLC). The study focuses on patients with unresectable stage III NSCLC who have detectable tumor DNA in their blood and have already received chemoradiotherapy and immunotherapy. This phase 3 trial aims to understand whether this combination can reduce minimal residual disease and improve survival outcomes. Participants with detectable tumor DNA (Cohort 1) will receive four cycles of platinum-based chemotherapy (carboplatin with either pemetrexed or paclitaxel), tremelimumab every 21 days, and durvalumab every 21 days. Those with undetectable tumor DNA (Cohort 2) will receive standard durvalumab treatment every two weeks for one year. Imaging scans such as PET/CT or CT of the chest will be performed every 12 weeks to monitor disease status. If no progression or significant side effects occur, patients will continue durvalumab to complete one year of treatment. During the study, participants will have blood drawn to measure circulating tumor DNA levels and undergo regular imaging to assess cancer progression. Researchers will evaluate changes in tumor DNA after chemotherapy, overall survival, progression-free survival, and adverse events related to the treatments. The study includes safety monitoring for up to 13 months and follows patients for up to two years to assess long-term outcomes. Participants will be involved in treatment and follow-up visits over this period to support comprehensive evaluation of the therapies.
CONDITIONS
Brief 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 unresectable stage III non-small cell lung cancer or locoregional recurrence after prior definitive treatment
- Completed platinum-based chemotherapy and radiation therapy to all known tumor sites (60 Gy ± 10%) without known disease progression
- Receiving consolidation durvalumab after chemoradiation, with less than 32 weeks since first durvalumab dose
- Able to potentially receive additional consolidation chemotherapy plus durvalumab and tremelimumab
- Availability of pre-treatment tumor tissue or tumor DNA sample for analysis
- Aged 18 years or older
- Weight greater than 30 kg
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Absolute neutrophil count greater than 1.0 x 10^9/L
- Platelets greater than 75 x 10^9/L
- Hemoglobin 9.0 g/dL or higher
- Measured creatinine clearance greater than 40 mL/min
- Serum bilirubin less than or equal to 1.5 times upper limit of normal (exceptions for Gilbert's syndrome)
- AST/ALT less than or equal to 2.5 times upper limit of normal (up to 5 times if liver metastases present)
- Ability to understand and sign informed consent
You will not qualify if you...
- Involvement in planning or conduct of the study
- Previous enrollment or randomization in this study
- Receipt of investigational product in another clinical study
- Mixed small cell and non-small cell lung cancer histology
- Active treatment for another primary malignancy (except stable adjuvant endocrine therapy for breast or prostate cancer)
- Use of immunosuppressive medication within 14 days before enrollment (with some corticosteroid exceptions)
- Unresolved toxicity greater than grade 2 from prior chemoradiation (except alopecia, vitiligo, and specific lab values)
- Prior grade 3 or higher immune-related adverse events or unresolved grade greater than 1 irAE limiting durvalumab use
- Major surgery within 4 weeks before study entry (excluding vascular access placement)
- Active or prior autoimmune or inflammatory disorders limiting durvalumab use (with specific exceptions)
- History of primary immunodeficiency or organ transplant requiring immunosuppression
- Hypersensitivity to carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel preventing re-administration
- Active infection including severe infections, active hepatitis B or C, tuberculosis, or HIV
- Receipt of live attenuated vaccine within 30 days before first chemotherapy and durvalumab dose
- Uncontrolled illnesses such as active infection, heart failure, uncontrolled hypertension, unstable angina, arrhythmia, 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants with detectable ctDNA receive 4 cycles of platinum doublet chemotherapy combined with tremelimumab and durvalumab, or carboplatin/paclitaxel if they have squamous cell carcinoma. Participants with undetectable ctDNA receive standard durvalumab treatment. Treatments are given intravenously every 2 to 3 weeks depending on cohort.
Every 2 to 3 weeks for up to 4 cycles and durvalumab administration continuing up to 1 year
Duration - Up to 2 years
Participants are evaluated with PET/CT and/or CT scans every 12 weeks and monitored for progression, survival, and adverse events up to 2 years after treatment initiation.
Visits every 12 weeks for imaging and assessments
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94304
Actively Recruiting
Research Team
R
Rene Bonilla
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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