A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Sponsor

Hunan Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05940532

Collaborator

(none)

Enrollment

Location

Arm

41.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Sugemalimab and Chemotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

41 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jun 14, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional arm Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.	Drug: Sugemalimab and Chemotherapy 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.

Arm

Intervention/Treatment

Experimental: Interventional arm

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

Drug: Sugemalimab and Chemotherapy

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.

Outcome Measures

Primary Outcome Measures

ORR [From the initiation of the first dose to 3 years]
Objective response rate

Secondary Outcome Measures

PFS [From the initiation of the first dose to 3 years]
Progression-free survival
OS [From the initiation of the first dose to 3 years]
Overall survival
iORR [From the initiation of the first dose to 3 years]
Objective response rate after induction therapy
AEs [From the initiation of the first dose to 90 days after the last dose]
Adverse events
Measurement of Quality of Life with EORTC QLQ-C30 questionnaire [From the initiation of the first dose to 3 years]
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 [From the initiation of the first dose to 3 years]
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 [From the initiation of the first dose to 3 years]
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"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.