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

Primary Purpose

Unresectable Stage III NSCLC

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Durvalumab
Carboplatin/ Paclitaxel
Pemetrexed/ Cisplatin
Pemetrexed/ Carboplatin
Radiation
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Stage III NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henan Cancer HospitalRecruiting
  • Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Durvalumab + platinum-based chemotherapy and radiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Grade ≥3 immune-mediated Adverse event
Grade ≥3 immune-mediated Adverse event

Secondary Outcome Measures

Progression-free survival (PFS)
Progression-free survival
Overall Survival (OS)
Overall Survival
Objective response rate(ORR)
Objective response rate
Duration of response(DOR)
Duration of response
Disease control rate(DCR)
Disease control rate
Time to death or distant metastasis(TTDM)
Time to death or distant metastasis

Full Information

First Posted
May 7, 2021
Last Updated
August 1, 2021
Sponsor
Shandong Cancer Hospital and Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04982549
Brief Title
A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC
Official Title
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）
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Stage III NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Durvalumab + platinum-based chemotherapy and radiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab (intravenous infusion)
Intervention Type
Drug
Intervention Name(s)
Carboplatin/ Paclitaxel
Intervention Description
Carboplatin /Paclitaxel, as per standard of care
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/ Cisplatin
Intervention Description
Pemetrexed / Cisplatin, as per standard of care
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/ Carboplatin
Intervention Description
Pemetrexed / Carboplatin , as per standard of care
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)
Primary Outcome Measure Information:
Title
Grade ≥3 immune-mediated Adverse event
Description
Grade ≥3 immune-mediated Adverse event
Time Frame
From the date of first dose until disease progression,assessed up to 4 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Progression-free survival
Time Frame
From date of first dose until the date of objective disease progression or death,assessed up to 4 years
Title
Overall Survival (OS)
Description
Overall Survival
Time Frame
From the date of first dose until death due to any cause,assessed up to 4 years
Title
Objective response rate(ORR)
Description
Objective response rate
Time Frame
From the date of first dose until the date of objective disease progression or death,assessed up to 4 years
Title
Duration of response(DOR)
Description
Duration of response
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
Title
Disease control rate(DCR)
Description
Disease control rate
Time Frame
From the date of first dose until 24 weeks.
Title
Time to death or distant metastasis(TTDM)
Description
Time to death or distant metastasis
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
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Adverse events
Time Frame
From the date of enrollment until disease progression,assessed up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinming Yu, professor
Phone
15553181309
Email
yujinming@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Feifei Teng, physician
Phone
13075305460
Email
tengfeifei16@126.com
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinming YU, professor
Phone
15553181309
Email
yujinming@126.com
First Name & Middle Initial & Last Name & Degree
Feifei Teng, physician
Phone
13075305460
Email
tengfeifei16@126.com
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinming Yu, professor
Phone
15553181309
Email
yujinming@126.com
First Name & Middle Initial & Last Name & Degree
Feifei Teng, physician
Phone
13075305460
Email
tengfeifei@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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