Immune Neoadjuvant Therapy Study of Durvalumab in Early Stage Non-small Cell Lung Cancer

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT03030131
Phase
PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    durvalumab 750 mg IV Day1, 15, 29

Study Details

Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA) NSCLC is curative surgery. Although patients treated with curative surgery have a better prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative chemotherapy versus no chemotherapy have shown a significant overall survival benefit from postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA. Likewise other randomized trials have demonstrated preoperative chemotherapy improves survival and recently the analyses also based on individual patients data of 15 randomized trials showed a significant benefit of preoperative chemotherapy on survival with the same survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become accepted in many countries. Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an attractive therapeutic option in the early stage NSCLC, which may reactivate host immune responses and enable longterm tumor control.

Key Dates

Start date
Jan 12, 2017
Status verified
Mar 2023
Primary completion
Aug 28, 2019
Completion
Aug 28, 2019

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab
    durvalumab 750 mg IV J1, J15, J29

Primary Outcome Measure

Surgical resection R0 [ Time Frame: 2 months ]

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