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The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04691063
Recruitment Status : Enrolling by invitation
First Posted : December 31, 2020
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Small-cell Lung Cancer Drug: SHR-1316; Carboplatin; Etoposide；Radiotherapy Drug: Palcebo; Carboplatin; Etoposide；Radiotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: SHR-1316 in combination with chemo-radiotherapy.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : May 15, 2025
Estimated Study Completion Date : May 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group A Drug: SHR-1316; Carboplatin; Etoposide；Radiotherapy
SHR-1316; Carboplatin; Etoposide；Radiotherapy（Part 1 and Part 2）
Placebo Comparator: Treatment group B Drug: Palcebo; Carboplatin; Etoposide；Radiotherapy
Palcebo; Carboplatin; Etoposide；Radiotherapy（Part 2）


Outcome Measures
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Primary Outcome Measures :
  1. OS [ Time Frame: up to 36 months ]
    Overall Survival


Eligibility Criteria
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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. 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.
Contacts and Locations
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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): NCT04691063


Locations
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China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04691063    
Other Study ID Numbers: SHR-1316-III-302
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: December 2020

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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
 Carboplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action