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

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.

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Small-cell Lung Cancer
• Intervention / Treatment: Drug: SHR-1316; Carboplatin; Etoposide；Radiotherapy; Drug: Palcebo; Carboplatin; Etoposide；Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 486
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	up to 36 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Anticipated): May 15, 2025
• Study Completion (Anticipated): May 15, 2025

Study Registration Dates

• First Submitted: December 25, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Carboplatin; Etoposide; Etoposide phosphate
• Other Study ID Numbers: SHR-1316-III-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No