The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer

NCT05496166 | Not Yet Recruiting Phase 3

• 1 other identifier: LungMate-015
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficiency between surgery and radiotherapy after SHR-1316 (Adebrelimab)and platinum-containing doublet induction therapy for limited-stage small cell lung cancer

Conditions

Limited Stage Small Cell Lung Cancer

Keywords

LD-SCLC; surgery; radiotherapy; neoadjuvant chemoimmunotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  It refers to the time from the first administration of SHR1316 in this study to the disease progression or death (including any cause of death in the case of no progression) , regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.

  2 years

Secondary Outcomes (6)

• incidence of adverse events

  through study completion, an average of 1.5 years

• pathological response

  up to 5 months

• objective response rate

  through study completion, an average of 1.5 years

• overall survival

  up to 60 months

• recurrence free survival

  up to 60 months

Other Outcomes (1)

• biological predicted markers

  through study completion, an average of 1.5 years

Study Arms (2)

surgery group

EXPERIMENTAL

SHR-1316+chemotherapy+surgery

Combination Product: chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy

radiotherapy group

ACTIVE COMPARATOR

SHR-1316+chemotherapy+radiotherapy

Combination Product: chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy

Interventions

chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy COMBINATION_PRODUCT

Induction treatment stage: SHR-1316(Adebrelimab)，20mg/kg,+Cisplatin 75mg/m2, d1+ etoposide 100mg/m2, d1,d2,d3, q3w, iv, 4 cycles. Patients who are able to receive surgery after assessed by two surgons would receive surgery or radiotherapy randomly. Adjuvant/ maintenance treatment stage: SHR-1316，20mg/kg, iv, q3w,up to 1 year

radiotherapy group; surgery group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• after signing informed consent;
• Aged 18-70;
• Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;
• For clinical stage IIB-III, all patients should have clear lymph node pathology by EBUS to exclud occult lymph node metastasis.
• Two thoracic surgeons assessed thar it would be able to achieve radical surgery or R0 resection after 4 cycles of treatment. Surgical approaches include lobectomy, sleeve resection and pneumonectomy
• ECOG performance status score 0-1 points;
• With a life expectancy of at least 12 weeks;
• At least one measurable tumor
• With normal Other major organs (liver, kidney, blood system, etc.) function:
• Absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90 g/L. Note: Patients should not receive blood transfusion or growth factor support within ≤ 14 days before blood collection during the screening period;
• \- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Serum total bilirubin ≤ 1.5×ULN (total bilirubin in patients with Gilbert syndrome must be \<3×ULN); Aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN, or AST and ALT ≤5×ULN in patients with liver metastases
• Female patients of childbearing potential must voluntarily use highly effective contraception during the study period until ≥ 120 days after the last dose of chemotherapy or SHR-1316, whichever is later, and have ≤ 7 days of urine or Serum pregnancy test results are negative;
• Unsterilized male patients must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose of chemotherapy or SHR-1316, whichever is later.

You may not qualify if:

• Received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy;
• Patients with other malignancies within five years prior to the start of the trial;
• Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc;
• With active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy;
• Allergy to the test drug;
• Have or currently have interstitial lung disease;
• Coexisting with HIV infection or active hepatitis;
• Patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial;
• Pregnant or breastfeeding women;
• Those who suffer from neurological diseases or mental illnesses who cannot cooperate;
• Other reasons that investigators deem inappropriate for enrollment.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital

Shang'ai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

Drug Therapy; Surgical Procedures, Operative; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of medicine

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 11, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 17, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)