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

August 1, 2021 updated by: Jinming Yu, Shandong Cancer Hospital and Institute

A Prospective Study to Evaluate the Safety of Concurrent Durvalumab (MEDI4736) With Chemoradiation Therapy（CRT）Followed by Durvalumab for Chinese Unresectable Stage III Non Small Cell Lung Cancer（NSCLC）

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 1.0 L or >40% predicted value and DLCO >30% predicted value
  • Must provide an archived tumor tissue block(or at least 15 newly cut unstained slides)≤3 years old; if archived sample unavailable then must provide a recent(≤3 months) tumor biopsy.

Exclusion Criteria:

  • Mixed small-cell and NSCLC histology
  • Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, 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 whole lung 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 the local labelling or known allergy/hypersensitivity to investigational product and/or its excipients
  • History of the following: allogeneic organ transplantation, active or prior autoimmune or inflammatory disorders, another primary malignancy, leptomeningeal carcinomatosis, active primary immunodeficiency
  • Uncontrolled intercurrent illness or active infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Durvalumab + platinum-based chemotherapy and radiation

All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:

cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.
Drug: Carboplatin/ Paclitaxel
Carboplatin /Paclitaxel, as per standard of care
Drug: Pemetrexed/ Cisplatin
Pemetrexed / Cisplatin, as per standard of care
Drug: Pemetrexed/ Carboplatin
Pemetrexed / Carboplatin , as per standard of care
Radiation: Radiation
5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)
Drug: Durvalumab
Durvalumab (intravenous infusion)
Other Names:
  • MEDI4736

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade ≥3 immune-mediated Adverse event
Time Frame: From the date of first dose until disease progression,assessed up to 4 years
Grade ≥3 immune-mediated Adverse event
From the date of first dose until disease progression,assessed up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From date of first dose until the date of objective disease progression or death,assessed up to 4 years
Progression-free survival
From date of first dose until the date of objective disease progression or death,assessed up to 4 years
Overall Survival (OS)
Time Frame: From the date of first dose until death due to any cause,assessed up to 4 years
Overall Survival
From the date of first dose until death due to any cause,assessed up to 4 years
Objective response rate(ORR)
Time Frame: From the date of first dose until the date of objective disease progression or death,assessed up to 4 years
Objective response rate
From the date of first dose until the date of objective disease progression or death,assessed up to 4 years
Duration of response(DOR)
Time Frame: From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years
Duration of response
From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years
Disease control rate(DCR)
Time Frame: From the date of first dose until 24 weeks.
Disease control rate
From the date of first dose until 24 weeks.
Time to death or distant metastasis(TTDM)
Time Frame: From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years
Time to death or distant metastasis
From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From the date of enrollment until disease progression,assessed up to 4 years
Adverse events
From the date of enrollment until disease progression,assessed up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 1, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4191L00116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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