A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (PACIFIC-9)

  • STATUS
    Recruiting
  • End date
    May 31, 2030
  • participants needed
    999
  • sponsor
    AstraZeneca
Updated on 24 October 2022
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (1.0 mi away) Contact
+81 other location
chemoradiotherapy
EGFR
medi4736
durvalumab
cancer chemotherapy
platinum-based chemotherapy
lung carcinoma

Summary

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

Details
Condition Non-Small Cell Lung Cancer
Treatment Placebo, durvalumab, monalizumab, oleclumab
Clinical Study IdentifierNCT05221840
SponsorAstraZeneca
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be ≥ 18 years at the time of screening
Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
Provision of a tumour tissue sample obtained prior to CRT
Documented tumour PD-L1 status by central lab
Documented EGFR and ALK wild-type status (local or central)
Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique
WHO performance status of 0 or 1 at randomization
Adequate organ and marrow function

Exclusion Criteria

History of another primary malignancy except for malignancy treated with curative intent with no known active disease > 5 years before the first dose of study intervention and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy, adequately treated carcinoma in situ or Ta tumours treated with curative intent and without evidence of disease
Mixed small cell and non-small cell lung cancer histology
Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC
Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia)
Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, ILD, pleural effusion, or pulmonary fibrosis diagnosed in the past 6 months prior to randomization
Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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