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

NCT04691063 | Unknown Phase 3

• 1 other identifier: SHR-1316-III-302
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

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.

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• OS

  Overall Survival

  up to 36 months

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR-1316; Carboplatin; Etoposide；Radiotherapy

Treatment group B

PLACEBO COMPARATOR

Drug: Palcebo; Carboplatin; Etoposide；Radiotherapy

Interventions

SHR-1316; Carboplatin; Etoposide；Radiotherapy DRUG

SHR-1316; Carboplatin; Etoposide；Radiotherapy（Part 1 and Part 2）

Treatment group A

Palcebo; Carboplatin; Etoposide；Radiotherapy DRUG

Palcebo; Carboplatin; Etoposide；Radiotherapy（Part 2）

Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-75 years of age.
• Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
• ECOG PS 0\~1.
• At least 1 measurable lesion as defined by RECIST v1.1.
• Adequate organ function.
• 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.
• Signed the informed consent form.

You may not qualify if:

• Mixed SCLC or NSCLC.
• Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
• Extensive-stage SCLC.
• Subjects who is surgically resectable.
• Subjects with malignant pleural effusion.
• 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.
• Active, known, or suspected autoimmune diseases.
• History of malignant tumors.
• Subjects with severe cardiovascular disease.
• Events of arterial/venous thrombosis within 6 months prior to the first dose.
• Subjects with serious infection.
• Subjects with active pulmonary tuberculosis (TB).
• Subjects with immunodeficiency diseases.
• Subjects with active hepatitis B virus or hepatitis C virus infection.
• Systemic immunosuppressants administation within 14 days prior to the first dose.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1316 in combination with chemo-radiotherapy.

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 31, 2020
• Study Start: January 22, 2021
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: February 26, 2021

Record last verified: 2020-12

Locations

CN (1)