Clinical trial NCT04691063: The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.
Official title: A Multi-center, Randomized, Double-blinded, Phase III Trial of SHR-1316 or Placebo in Combination With Chemo-radiotherapy in Patients With Limited-stage Small-cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Small-cell Lung Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-31
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1316 in combination with chemo-radiotherapy.
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy and safety of SHR-1316 in combination with chemo-radiotherapy in patients with LS-SCLC.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-75 years of age.
2. Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
3. ECOG PS 0\~1.
4. At least 1 measurable lesion as defined by RECIST v1.1.
5. Adequate organ function.
6. Female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. And female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
7. Signed the informed consent form.

Exclusion Criteria:

1. Mixed SCLC or NSCLC.
2. Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
3. Extensive-stage SCLC.
4. Subjects who is surgically resectable.
5. Subjects with malignant pleural effusion.
6. Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function.
7. Active, known, or suspected autoimmune diseases.
8. History of malignant tumors.
9. Subjects with severe cardiovascular disease.
10. Events of arterial/venous thrombosis within 6 months prior to the first dose.
11. Subjects with serious infection.
12. Subjects with active pulmonary tuberculosis (TB).
13. Subjects with immunodeficiency diseases.
14. Subjects with active hepatitis B virus or hepatitis C virus infection.
15. Systemic immunosuppressants administation within 14 days prior to the first dose.
16. Subjects who received major surgery within 28 days prior to the first dose.
17. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
18. Subjects who have previously received tissue/organ transplants.
19. Subjects with history of severe allergic reactions to monoclonal antibodies/fusion protein drugs.
20. Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.

Primary outcomes:
measure: OS
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
Study officials:
References: