A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC

Last updated: August 1, 2021
Sponsor: Shandong Cancer Hospital and Institute
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04982549
D4191L00116
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with histologically or cytologically-documented NSCLC
  • Locally advanced, unresectable (Stage III) NSCLC
  • World Health Organization (WHO) performance status 0-1
  • At least one measurable lesion, not previously irradiated
  • Must have a life expectancy of at least 12 weeks at randomization
  • Adequate lung function: Pre- or post-bronchodilator forced expiratory volume 1 of 1.0L or >40% predicted value and DLCO >30% predicted value
  • Must provide an archived tumor tissue block(or at least 15 newly cut unstainedslides)≤3 years old; if archived sample unavailable then must provide a recent(≤3months) tumor biopsy.

Exclusion

Exclusion Criteria:

  • Mixed small-cell and NSCLC histology
  • Receipt of prior or current cancer treatment, including but not limited to, radiationtherapy, investigational agents, chemotherapy, Durvalumab and mAbs.
  • Prior exposure to immune-mediated therapy, including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.
  • Patients whose radiation treatment plans are likely to encompass a volume of wholelung receiving ≥20 Gy in total (V20) of more than 35% of lung volume
  • Planned radiation cardiac dose V50>25%
  • Any medical contraindication of platinum-based doublet chemotherapy as listed in thelocal labelling or known allergy/hypersensitivity to investigational product and/orits excipients
  • History of the following: allogeneic organ transplantation, active or prior autoimmuneor inflammatory disorders, another primary malignancy, leptomeningeal carcinomatosis,active primary immunodeficiency
  • Uncontrolled intercurrent illness or active infection

Study Design

Total Participants: 35
Study Start date:
January 21, 2021
Estimated Completion Date:
March 01, 2023

Study Description

Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD)based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.

Connect with a study center

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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