The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC

June 12, 2023 updated by: LVHUA WANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Prospective, Two Cohort, Multicenter Phase II Clinical Study of Envafolimab Combined With Concurrent Chemoradiotherapy and Immune Maintenance Therapy For Limited Stage Small Cell Lung Cancer

To evaluate the efficacy and safety of envafolimab combined with concurrent chemoradiotherapy in limited stage small cell lung cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody. Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The result of histopathological or cytological diagnosis is small cell lung cancer.
  • Diagnosed as limited stage by imaging examination (lesion limited to half chest and one radiotherapy field, without malignant pleural or pericardial effusion); And at least one measurable lesion that meets the RECIST 1.1 standard.
  • Have not received systematic treatment in the past, and initially underwent 2 cycles of etoposide+cisplatin/carboplatin induction therapy.
  • Age 18-75 years old, male or non pregnant female.
  • The expected survival period is>3 months.
  • ECOG score 0-1.
  • Weight>30 kilograms.
  • All patients underwent chest CT, head MRI, abdominal CT or MRI, and whole body bone scan before treatment to clarify.
  • Hematological indicators: white blood cell (WBC) count ≥ 4 * 109/L, absolute neutrophil count (ANC) ≥ 1.5 * 109/L, hemoglobin (Hb) level>100 g/L, platelet (Plt) count>100 * 109/L, serum creatinine (Cr) level<1.5 times the upper limit of normal value, serum alanine transaminase (AST) and glutamic transaminase (ALT) levels<2.5 times the upper limit of normal value, and serum bilirubin level ≤ 1.5 times the upper limit of normal value.
  • The patient has signed an informed notice and is willing and able to comply with the visit, treatment plan, laboratory examination, and other research procedures of the research plan.

Exclusion Criteria:

  • Patients with non-small cell lung cancer or mixed components of small cell lung cancer in histopathology.
  • Patients with extensive stage small cell lung cancer (ES-SCLC).
  • Merge malignant pleural effusion and pericardial effusion.
  • Pregnant and lactating women.
  • Merge patients with more severe underlying diseases.
  • Patients who have previously been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.).
  • Patients may require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive doses for comorbidities.
  • Patients with immunodeficiency disorders and a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; vitiligo or childhood asthma. Patients who have completely relieved and do not require any intervention after adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included).
  • Those whose laboratory test values during the screening period before enrollment do not meet relevant standards.
  • Patients with significantly reduced heart, liver, lung, kidney, and bone marrow function.
  • Serious and uncontrolled internal diseases and infections.
  • Simultaneously using other investigational drugs or in other clinical trials.
  • Refusal or inability to sign informed consent form for participation in the experiment.
  • A history of allergies to etoposide, cisplatin, or any excipients.
  • Researchers have determined that patients are not suitable to participate in the study and are unlikely to comply with the study procedures, limitations, and requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated radiotherapy group

Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times.

Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
Drug: Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)

Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times.

Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.

Other Names:
  • Hypofractionated Radiotherapy Group
Experimental: Conventional Radiotherapy
Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
Drug: Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)

Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times.

Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.

Other Names:
  • Conventional Radiotherapy Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year PFS rate
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
2-yaer progression-free survival rate
From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of randomization until the date of death(up to 24 months)
Overall survival
From date of randomization until the date of death(up to 24 months)
ORR
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
Objective Response Rate
From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
DCR
Time Frame: From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
Disease control rate
From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
DOR
Time Frame: From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
Duration of response
From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
Adverse event rate Adverse event rate Adverse event rate
Time Frame: From date of randomization until the date of toxicity or PD (up to 24 months)
Number of participants with adverse events as a measure of safety and tolerability
From date of randomization until the date of toxicity or PD (up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: LvHua Wang, Doc, Cancer Hospital Chinese Academy of Medical Sciences,ShenZhen Cencer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

April 30, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT-LC03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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