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Clinical Study of PD-1 Antibody (BGB-A317) Plus Chemotherapy (Cisplatin and Etoposide) for Limited Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04542369
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary:
This is a phase II, non-randomized, open-label, single center study to evaluate the efficacy and safety of neoadjuvant BGB-A317 + chemotherapy (cisplatin and etoposide) followed by radical surgery and adjuvant BGB-A317 immunotherapy as first-line treatment in patients limited-stage SCLC.

Condition or disease Intervention/treatment Phase
Small-cell Lung Cancer Drug: BGB-A317 Plus Chemotherapy (Cisplatin and Etoposide) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of PD-1 Antibody (BGB-A317) Plus Chemotherapy (Cisplatin and Etoposide) for Limited Stage Small Cell Lung Cancer
Estimated Study Start Date : January 31, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : November 30, 2025


Arm Intervention/treatment
Experimental: ES-SCLC
Induction therapy: BGB-A317 200mg, qd, ivgtt, 2-4 cycles; cisplatin 75mg/m2, d1+ etoposide 100mg/m2, d1,d2,d3, q3w, 2-4 cycles. Maintenance therapy: BGB-A317 200mg, qd, ivgtt, thereafter until progression disease, or other discontinuation criteria (intolerant toxicity, no more clinical benefit, receiving another anti-tumor regimen [except radiotherapy], withdrawal of informed consent or death).
Drug: BGB-A317 Plus Chemotherapy (Cisplatin and Etoposide)
Inductive/neoadjuvant therapy: BGB-A317 + EP Maintenance/adjuvant therapy: BGB-A317




Primary Outcome Measures :
  1. Safety: frequency of severe adverse events [ Time Frame: up to 18 months ]
    The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: up to 60 months ]
    It refers to the time from the first administration of TQB2450 in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.

  2. Overall survival (OS) [ Time Frame: up to 63 months ]
    It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.

  3. Health related quality of life (HRQol) [ Time Frame: up to 12 months ]
    The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 & LC13, Version 3). EORTC's QLQ-C30 & LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.

  4. Major pathologic response (MPR) [ Time Frame: up to 5 months ]
    MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.

  5. Objective response rate (ORR) [ Time Frame: up to 4 months ]

    It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the inductive/neoadjuvant therapy.

    Only patients with measurable lesions at baseline will be analyzed.


  6. Disease-free survival (DFS) [ Time Frame: up to 60 months ]
    It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient shall sign the Informed Consent Form.
  2. Aged 18 ≥ years.
  3. Histological or cytological diagnosis of SCLC by needle biopsy, and limited stage (local advanced) confirmed by imageological examinations.
  4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
  5. Life expectancy is at least 12 weeks.
  6. At least 1 measurable lesion according to RECIST 1.1.
  7. Patients with good function of other main organs (liver, kidney, blood system, etc.):

    • ANC count ≥1.5×10^9/L, platelet count ≥100×10^9/L#hemoglobin

      ≥90 g/L;

    • the international standard ratio of prothrombin time (INR) and prothrombin time (PT) < 1.5 times of upper limit of normal (ULN);
    • partial thromboplastin time (APTT) ≤1.5×ULN;
    • total bilirubin ≤1.5×ULN;
    • alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.
  8. No systemic metastasis;
  9. Expected to be completely resected;
  10. Good cardiopulmonary function and can tolerate surgical treatment;
  11. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of TQB2450 (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
  12. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of TQB2450 (whichever is later).

Exclusion Criteria:

  1. Participants who have received any systemic anti-cancer treatment for SCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
  2. Participants with cancer other than SCLC (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study;
  3. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
  4. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
  5. Participants who are allergic to the test drug or any auxiliary materials;
  6. Have or currently have interstitial lung disease;
  7. Participants with active HIV;
  8. Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;
  9. Pregnant or lactating women;
  10. Any conditions of malabsorption;
  11. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
  12. Other factors that researchers think it is not suitable for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542369


Contacts
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Contact: Peng Zhang, MD +8613512185932 zhangpeng1121@outlook.com

Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
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Responsible Party: Peng Zhang, Director of science and education department, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT04542369    
Other Study ID Numbers: LungMate-006(FK-LYIB-001)
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The researchers will consider whether IPD is available to other researchers only after the paper is published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action