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A Trial of GFH018 in Combination With Toripalimab and Concurrent Chemoradiotherapy in Stage III NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05386888
Recruitment Status : Not yet recruiting
First Posted : May 23, 2022
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Genfleet Therapeutics (Shanghai) Inc.

Study Description
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Brief Summary:
This is a phase II trial assessing the efficacy and safety of GFH018 in combination with Toripalimab given concurrently with platinum-based chemoradiotherapy (CRT) in patients with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment Phase
NSCLC, Stage III Drug: GFH018 Drug: Toripalimab Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Radiation: Thoracic Radiation Therapy (TRT) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Primary Purpose: Treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of GFH018 in Combination Toripalimab Given Concurrently With Platinum-based Chemoradiotherapy for Participants With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC)
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: treatment
GFH018 80mg 7-Day on/ 7-Day off and 4 doses of Toripalimab 240mg Q3W concurrently with standard chemo-radiotherapy, followed by GFH018 80mg 14-Day on/ 14-Day off and Toripalimab 3mg/kg Q2W for up to 48 weeks
 Drug: GFH018
80mg BID 7-Day on/ 7-Day off oral

Drug: Toripalimab
240mg Q3W IV

Drug: Paclitaxel
200 mg/m^2 IV

Drug: Carboplatin
AUC6 IV

Drug: Cisplatin
75 mg/m^2 IV

Drug: Pemetrexed
500 mg/m^2 IV

Radiation: Thoracic Radiation Therapy (TRT)
Thoracic Radiation Therapy (TRT)

Drug: Paclitaxel
45 mg/m^2 IV

Drug: Carboplatin
AUC2 IV

Drug: GFH018
80mg BID 14-Day on/ 14-Day off oral

Drug: Toripalimab
3mg/kg Q2W IV


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From the date of enrolment of the first patient up to 28 months , which is also16 months after the enrolment of the last patient ]

    Objective response rate (ORR) is defined as the percentage of patients with objective response (OR).

    OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response (Complete Response (disappearance of all target and non-target lesions; no new lesions) or Partial Response (≥decrease in the sum of the largest diameters of target lesions; no new lesions)) across all assessment points from enrollment to termination of trial treatment. Radiological tumour assessment was performed using CT scans.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically or cytologically confirmed non small cell lung carcinoma Locally advanced, unresectable (Stage III) NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Measurable disease (according to RECIST v1.1 criteria)
  • Life expectancy > 6 months

Exclusion Criteria:

  • Patient with mixed small-cell and non-small-cell histologic features Patient with pleural or pericardial effusions proven to be malignant Prior or current cancer treatment, including but not limited to, chemotherapy, radiotherapy or molecular targeted therapy for NSCLC
  • Prior exposure to immune-mediated therapy, including but not limited to, TGFβ inhibitors, anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies.
  • Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386888


Locations
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China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000
Contact: LU YOU, professor    18980601763    radyoulu@hotmail.com   
Sponsors and Collaborators
Genfleet Therapeutics (Shanghai) Inc.
More Information
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Responsible Party: Genfleet Therapeutics (Shanghai) Inc.
ClinicalTrials.gov Identifier: NCT05386888    
Other Study ID Numbers: GFH018X1202
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genfleet Therapeutics (Shanghai) Inc.:
Locally Advanced
Unresectable NSCLC
TGF-βRI
PD-1
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
 Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors