Personalized Treatment for Stage III NSCLC

This study is for people with unresectable Stage III non-small cell lung cancer (NSCLC) or recurrent NSCLC who have already completed chemotherapy and radiation. It aims to see if adding Tremelimumab and extra chemotherapy (Carboplatin, Pemetrexed, Paclitaxel, or Cisplatin) to the standard treatment, Durvalumab, can reduce the amount of circulating tumor DNA (ctDNA) in your blood. ctDNA are tiny pieces of cancer cells found in the blood. The study will measure changes in ctDNA levels after 12 weeks of treatment to see how well the personalized approach works. This study is testing an immunotherapy approach.

Study design
This interventional study plans to enroll 48 participants. It will compare outcomes for participants with detectable ctDNA versus those with undetectable ctDNA at the start of the study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in ctDNA levels at 12 weeks after chemotherapy.

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NCT04585490

Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC

Recruiting
PHASE3Ages 18+InterventionalTreatment
Maximilian Diehn
~48 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:DurvalumabCarboplatinPemetrexedPaclitaxelCisplatinAVENIO ctDNA Surveillance Kit

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ctDNA Level Following Chemotherapy
Measured over 12 weeks
Non Small Cell Lung Cancer
NSCLC, Stage III
Nsclc
1 sites across 1 states
California1
  • Maximilian Diehn, MD · PRINCIPAL_INVESTIGATOR · Stanford Universiy

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Eligibility criteria

Inclusion

Subjects with Grade ≥ 2 neuropathy will be evaluated on a case by case basis after consultation with the Protocol Director / Principal Investigator
Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by treatment with durvalumab may be included (ie, hearing loss) only after consultation with the Protocol Director / Principal Investigator.
Grade 3 or higher clinically significant infection
Active known Hepatitis B \[known positive results for HBV surface antigen (HBsAg) within 2 months prior to enrollment\]. EXCEPTION: Subjects with a past or resolved HBV infection, defined as the presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg are eligible
Active known Hepatitis C (HCV). EXCEPTION: Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
Active known tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
Active known HIV infection
Ongoing or active infection
Symptomatic congestive heart failure
Uncontrolled hypertension
Unstable angina pectoris
Cardiac arrhythmia
Interstitial lung disease
Serious chronic gastrointestinal conditions associated with diarrhea
Psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
  • Change in ctDNA Level Following Chemotherapy12 weeks

    Participants in Cohort 1 MRD+ will be assessed for ctDNA levels at baseline and end of treatment, expected to be 4 cycles of 3 weeks per cycle (defined as ctDNA evaluable set or ctDES). The outcome will be assessed as the number of participants with a ≥ 3 fold decrease in ctDNA level, a number without dispersion.