Neoadjuvant Durvalumab and Chemotherapy Followed by Surgery/CRT and Durvalumab in Borderline Resectable Stage III NSCLC

Sponsor
Bi Nan
Study ID
NCT06998719
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Borderline Resectable Carcinoma
  • Non-small Cell Lung Cancer Stage III

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Neoadjuvant durvalumab (MEDI 4736)and platinum-based chemotherapy, followed by either surgery and adjuvant durvalumab or CRT and consolidation durvalumab, in borderline resectable stage III NSCLC

Study Details

A Phase II, interventional study of neoadjuvant durvalumab (MEDI 4736) and platinum-based Chemotherapy, followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with borderline resectable stage III Non-small Cell Lung Cancer (NSCLC) (ACCESS)

Key Dates

Start date
Jul 31, 2025
Status verified
May 2025
Primary completion
May 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Cohort 1 (Surgery)
    After 2 cycles of neoadjuvant durvalumab (1500 mg) + chemotherapy, multidisciplinary team (MDT)-determined participants with resectable tumor (according to MDT re-assessment) will receive a further 1-2 cycles of neoadjuvant durvalumab + chemotherapy followed by surgery. Participants should only go onto surgical resection if the MDT evaluation indicates that an R0 resection is feasible. After surgery, patients will then go on to receive adjuvant durvalumab 1500 mg q4w until recurrence or up to one year (maximum 12 cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
  • Active Comparator: Cohort 2 (CRT)
    Participants with unresectable tumor (according to MDT re-assessment) will receive CRT. Participants will receive platinum-based chemotherapy for a maximum of 2 cycles. Radiotherapy at a dose of 5 fractions/week for \~6 weeks (± 3 days) (total 60 Gy± 10%) can be given sequentially or concurrently with chemotherapy. After CRT, patients will receive consolidation durvalumab 1500 mg q4w until disease progression or up to one year (maximum 12 cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Primary Outcome Measure

Resection rate [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

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