Chemo-immunotherapy, Hypo-fractionated RT and Maintenance Immunotherapy for Stage III NSCLC.

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Study ID
NCT05128630
Phase
PHASE2
Status
Unknown

Conditions

  • NSCLC, Stage III

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Patients will receive 1500 mg durvalumab via IV infusion q3w concomitant with chemotherapy (Cisplatin/carboplatin plus etoposide) for up to a maximum of 3 cycles, then via IV infusion at the same interval during sequential radiotherapy and then every 4 weeks for up to a maximum of 12 months or until confirmed disease progression, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Study Details

Aim of this phase 2 study is to evaluate the safety and the efficacy of the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT.

Key Dates

Start date
Oct 28, 2021
Status verified
Sep 2023
Primary completion
Nov 28, 2024
Completion
Nov 28, 2025

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single-arm
    Chemotherapy plus durvalumab, hypofractionated RT plus durvalumab, durvalumab maintenance

Primary Outcome Measure

Safety [ Time Frame: Within 6 months from study enrollment ]

Central Contacts

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