A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Sugemalimab and Chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br>Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy. | Drug: Sugemalimab and Chemotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate | From the initiation of the first dose to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | From the initiation of the first dose to 3 years | 
| OS | Overall survival | From the initiation of the first dose to 3 years | 
| iORR | Objective response rate after induction therapy | From the initiation of the first dose to 3 years | 
| AEs | Adverse events | From the initiation of the first dose to 90 days after the last dose | 
| 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 | From the initiation of the first dose to 3 years | 
| 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 | From the initiation of the first dose to 3 years | 
| 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 | From the initiation of the first dose to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, chemotherapy, radiotherapy, surgery, non-small cell lung cancer