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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05904015
• Other study ID #: RT-LC03
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: LvHua Wang, Doc
• Phone: 0755-66618168
• Email: wlhwq[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

References & 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. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ORR	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.
Secondary	DCR	Disease control rate	From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
Secondary	DOR	Duration of response	From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
Secondary	OS	Overall survival	From date of randomization until the date of death(up to 24 months)
Secondary	Adverse event rate Adverse event rate Adverse event rate	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)