Overview
The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.
Description
This study is planned to enroll approximately 346 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to the experimental and control arm. The experimental arm would receive sugemalimab, while the control arm would receive placebo.Tumor assessment will be conducted using computed tomography/magnetic resonance imaging and MRD detection will be performed along with radiologic review during each visit. The above assessment will be conducted every 12 weeks for the first 2 years, every 24 weeks for the third year, and annually thereafter until confirmed disease progression per RECIST 1.1 or death.The primary endpoint is PFS ,which is defined as the time from the date of randomization to the date of disease progression (per RECIST 1.1), any cause of death, loss to follow-up, or initiation of new antitumor therapy, whichever occurred first.
Eligibility
Inclusion Criteria:
1、18 years or older. 2、Histologically or cytologically confirmed small cell lung cancer.
3、ECOG PS=0-1 at enrollment; 4、Limited-stage SCLC (Stage I-III, by AJCC 8th Edition Cancer
Staging), and can be safely treated with definitive radiation doses).
5、Inoperable SCLC, or the patient has contraindications to surgery, or the patient refuses
surgery.
6、Completion of 4 cycles of chemotherapy (etoposide + carboplatin/cisplatin) concurrent or
sequential with radiotherapy during the first two cycles of chemotherapy.
7、After the completion of concurrent or sequential chemoradiotherapy, prophylactic
intracranial irradiation (PCI) is allowed based on the common practice of individual sites.
8、The start of concurrent radiotherapy should be no later than the last day of the second
course of chemotherapy (the first day of the third cycle of chemotherapy). The interval
between the end of chemotherapy cycle and beginning of radiotherapy must not exceed 35 days
for sequential chemoradiotherapy.
9、Radiotherapy must be either total 60-66Gy over 6 weeks for the standard qd regimen or
total 45Gy over 3 weeks for hyperfractionated bid schedules.
10、Absence of progression after concurrent/sequential chemoradiotherapy (responses should
be complete response [CR], partial response [PR] and stable disease [SD]); 11、For patients
not receiving PCI, the first dose of sugemalimab shall be administered within 42 days after
the completion of chemoradiation therapy. For patients receiving PCI, the first dose of
sugemalimab shall be administered within 56 days after the completion of chemoradiation
therapy.
12、Life expectancy ≥ 12 weeks. 13、Can provide tumor tissue samples (fresh or archived) for
whole exome sequencing; 14、Women of childbearing potential and fertile men must agree to
use an effective contraceptive method from signing the master ICF until 180 days after the
last dose of investigational product. Women of childbearing potential include premenopausal
women and women who became menopausal less than 2 years ago. Women of childbearing
potential must have a negative pregnancy test ≤7 days prior to the first dose of
investigational product.
15、The subject should have good compliance, who would participate in the research
voluntarily, and sign the informed consent.
Exclusion Criteria:
1. Histologically or cytologically diagnosed mixed small cell lung cancer or non-small
cell lung cancer.
2. Extensive-stage small cell lung cancer.
3. Has malignant pleural or pericardial effusion.
4. Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with
immune checkpoint inhibitors.
5. Subjects with active, unstable systemic diseases, such as active infection,
uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris,
acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases,
HIV infection.
6. Has history of interstitial lung disease (ILD), drug-induced ILD, or active ILD which
required systemic glucocorticoid or immunosuppressive therapy.
7. History of other malignancies within 5 years (excluding basal cell carcinoma of the
skin or other carcinoma in situ that has been resected).
8. Pregnant or lactating women.
9. Those who are allergic to the research drug or its components.
10. Subjects who are deemed unable to comply with the study requirements or complete the
study.
11. Those with insufficient function of bone marrow or other important organs.