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

Part of paid clinical trials in Stanford, California.

Sponsor
Maximilian Diehn
Study ID
NCT04585490
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Cohort 1 (1500 mg IV every 21 days, for 1 year), •Cohort 2 (10mg/kg every 2 weeks for 1 year)
  • Carboplatin — DRUG
    Target area under the curve (AUC) not to exceed 750mg on Day 1 of every 21-day cycle
  • Pemetrexed — DRUG
    500mg/m2 on Day 1 of every 21-day cycle
  • Paclitaxel — DRUG
    175mg/m2 on Day 1 of every 21-day cycle
  • Cisplatin — DRUG
    Cisplatin (75mg/m2 per institution guidelines) may be substituted for Carboplatin
  • AVENIO ctDNA Surveillance Kit — DEVICE
    Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)
  • Tremelimumab — DRUG
    not to exceed 75mg IV on Day 1 of every 21-day cycle

Study Details

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

Key Dates

Start date
Aug 25, 2021
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Apr 30, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 minimal residual disease positive (MRD+)
    Subjects with detectable ctDNA will receive 4 cycles of platinum doublet chemotherapy \[carboplatin/pemetrexed\], tremelimumab (75 mg IV every 21 days) and durvalumab (1500 mg IV every 21 days), except subjects with squamous cell carcinoma histology will receive carboplatin/paclitaxel. Subjects will be evaluated with PET/CT and/or computed tomography (CT) thorax every 12 weeks. Following ctDNA evaluation, in the absence of progression or toxicity, subject will continue with durvalumab to complete 1 year of treatment as standard of care.
  • Experimental: Cohort 2 minimal residual disease negative (MRD )
    Subjects with undetectable ctDNA at study enrollment will receive standard of care durvalumab (10 mg/kg every 2 weeks, or equivalent, for 1 year). If subjects in Cohort 2 MRD progress prior to close of study, blood will be drawn for ctDNA testing.

Primary Outcome Measure

Change in ctDNA Level Following Chemotherapy [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94304
Rene NH Bonilla
[email protected]
650-498-7703
Maximilian Diehn, MD (PRINCIPAL_INVESTIGATOR)

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Stanford University· Stanford, CA

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