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

NCT05904015 | Not Yet Recruiting Phase 2

• 1 other identifier: RT-LC03
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lung Neoplasms

Keywords

Envafolimab/SCLC/Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year PFS rate

  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 Outcomes (5)

• ORR

  From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.

• DCR

  From date of randomization until the date of intolerance the toxicity or PD up to 24 months.

• DOR

  From date of randomization until the date of intolerance the toxicity or PD up to 24 months.

• OS

  From date of randomization until the date of death(up to 24 months)

• Adverse event rate Adverse event rate Adverse event rate

  From date of randomization until the date of toxicity or PD (up to 24 months)

Study Arms (2)

Hypofractionated radiotherapy group

EXPERIMENTAL

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)

Conventional Radiotherapy

EXPERIMENTAL

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)

Interventions

Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy) DRUG

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.

Also known as: Hypofractionated Radiotherapy Group

Hypofractionated radiotherapy group

Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy) DRUG

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.

Also known as: Conventional Radiotherapy Group

Conventional Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Related Publications (5)

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirillo J. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol. 2006 Oct 1;24(28):4539-44. doi: 10.1200/JCO.2005.04.4859.

  PMID: 17008692 BACKGROUND

• Toh CK, Gao F, Lim WT, Leong SS, Fong KW, Yap SP, Hsu AA, Eng P, Koong HN, Thirugnanam A, Tan EH. Differences between small-cell lung cancer and non-small-cell lung cancer among tobacco smokers. Lung Cancer. 2007 May;56(2):161-6. doi: 10.1016/j.lungcan.2006.12.016. Epub 2007 Jan 31.

  PMID: 17270313 BACKGROUND

• Sun JM, Choi YL, Ji JH, Ahn JS, Kim KM, Han J, Ahn MJ, Park K. Small-cell lung cancer detection in never-smokers: clinical characteristics and multigene mutation profiling using targeted next-generation sequencing. Ann Oncol. 2015 Jan;26(1):161-166. doi: 10.1093/annonc/mdu504. Epub 2014 Oct 29.

  PMID: 25355724 BACKGROUND

• Sundstrom S, Bremnes RM, Kaasa S, Aasebo U, Hatlevoll R, Dahle R, Boye N, Wang M, Vigander T, Vilsvik J, Skovlund E, Hannisdal E, Aamdal S; Norwegian Lung Cancer Study Group. Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: results from a randomized phase III trial with 5 years' follow-up. J Clin Oncol. 2002 Dec 15;20(24):4665-72. doi: 10.1200/JCO.2002.12.111.

  PMID: 12488411 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• LvHua Wang, Doc

  Cancer Hospital Chinese Academy of Medical Sciences,ShenZhen Cencer

  STUDY CHAIR

Central Study Contacts

LvHua Wang, Doc

CONTACT

0755-66618168; wlhwq@yahoo.com

Wei Jiang, Doc

CONTACT

0755-66618168; szchiec@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: June 15, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share