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A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sugemalimab and Chemotherapy
Sponsored by
Hunan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring immunotherapy, chemotherapy, radiotherapy, surgery, non-small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1.18 to 75 years old, both male and female; 2.ECOG score: 0-1; 3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer; 4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy; 5.Measurable lesions available; 6.Major organ function is basically normal; 7.Estimated survival time is at least 6 months; 8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion. Exclusion Criteria: Histologically or cytologically confirmed mixed SCLC and NSCLC; Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.); Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC; Previous thoracic radiotherapy; Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose; Systemic immunostimulant therapy before the first dose; Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment; Subjects with autoimmune diseases; Other malignant tumors other than non-small cell lung cancer within 5 years before screening; Known or suspected interstitial pneumonia; Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function; Severe cardiovascular and cerebrovascular diseases; Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose; Arteriovenous thrombotic events within 3 months before the first dose; Positive HIV test; Active hepatitis B or C; Evidence of active tuberculosis infection within 1 year before the first dose; Serious infection within 4 weeks before the first dose; History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study; Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose; Previous or planned allogeneic bone marrow transplantation or solid organ transplantation; History of severe allergic reactions to other monoclonal antibodies/fusion proteins; Allergic to any component of the randomized treatment regimen; Female subjects who are pregnant, lactating, or planning to get pregnant during the study period; Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse; Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.

Sites / Locations

  • Hunan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional arm

Arm Description

Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.

Outcomes

Primary Outcome Measures

ORR
Objective response rate

Secondary Outcome Measures

PFS
Progression-free survival
OS
Overall survival
iORR
Objective response rate after induction therapy
AEs
Adverse events
Measurement of Quality of Life with EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire
EORTC QLQ-LC13 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine"

Full Information

First Posted
June 26, 2023
Last Updated
July 7, 2023
Sponsor
Hunan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05940532
Brief Title
A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
Official Title
A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunan Cancer Hospital

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
The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
immunotherapy, chemotherapy, radiotherapy, surgery, non-small cell lung cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.
Intervention Type
Drug
Intervention Name(s)
Sugemalimab and Chemotherapy
Intervention Description
Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate
Time Frame
From the initiation of the first dose to 3 years
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
From the initiation of the first dose to 3 years
Title
OS
Description
Overall survival
Time Frame
From the initiation of the first dose to 3 years
Title
iORR
Description
Objective response rate after induction therapy
Time Frame
From the initiation of the first dose to 3 years
Title
AEs
Description
Adverse events
Time Frame
From the initiation of the first dose to 90 days after the last dose
Title
Measurement of Quality of Life with EORTC QLQ-C30 questionnaire
Description
EORTC QLQ-C30 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Time Frame
From the initiation of the first dose to 3 years
Title
Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire
Description
EORTC QLQ-LC13 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Time Frame
From the initiation of the first dose to 3 years
Title
Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire
Description
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine"
Time Frame
From the initiation of the first dose to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.18 to 75 years old, both male and female; 2.ECOG score: 0-1; 3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer; 4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy; 5.Measurable lesions available; 6.Major organ function is basically normal; 7.Estimated survival time is at least 6 months; 8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion. Exclusion Criteria: Histologically or cytologically confirmed mixed SCLC and NSCLC; Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.); Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC; Previous thoracic radiotherapy; Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose; Systemic immunostimulant therapy before the first dose; Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment; Subjects with autoimmune diseases; Other malignant tumors other than non-small cell lung cancer within 5 years before screening; Known or suspected interstitial pneumonia; Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function; Severe cardiovascular and cerebrovascular diseases; Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose; Arteriovenous thrombotic events within 3 months before the first dose; Positive HIV test; Active hepatitis B or C; Evidence of active tuberculosis infection within 1 year before the first dose; Serious infection within 4 weeks before the first dose; History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study; Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose; Previous or planned allogeneic bone marrow transplantation or solid organ transplantation; History of severe allergic reactions to other monoclonal antibodies/fusion proteins; Allergic to any component of the randomized treatment regimen; Female subjects who are pregnant, lactating, or planning to get pregnant during the study period; Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse; Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huai Liu, MD
Phone
+8619918909231
Email
liuhuai@hnca.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Wang, MD
Organizational Affiliation
the Department of Radiation Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huai Liu, MD
Organizational Affiliation
the Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huai Liu, MD
Phone
+8619918909231
Email
liuhuai@hnca.org.cn

12. IPD Sharing Statement

Learn more about this trial

A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

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