A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer

A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment

SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy

Study Overview

• Status: Not yet recruiting
• Conditions: Limited-stage Small Cell Lung Cancer, LS-SCLC
• Intervention / Treatment: Drug: SHR-1316

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

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. The age is 18-75 years old (including both ends), regardless of gender;
2. Histologically confirmed limited stage small cell lung cancer ;
3. ECOG PS 0 ~ 1;
4. Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
5. The last chemotherapy must be finished before or at the same time of radiotherapy.
6. The disease did not progress after concurrent chemoradiotherapy;
7. The expected survival time was more than 3 months;
8. Pulmonary function: FEV1 > 70%;

Exclusion Criteria:

1. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
2. Mixed SCLC or NSCLC confirmed by histology;
3. Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
4. Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
5. Extensive SCLC;
6. Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
7. Interstitial pneumonia
8. History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
9. HIV, active Hepatitis B or Hepatitis C infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SHR-1316	Drug: SHR-1316; Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 27, 2020
• Primary Completion (ANTICIPATED): May 27, 2023
• Study Completion (ANTICIPATED): December 27, 2023

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (ACTUAL): November 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 27, 2020
• Last Verified: November 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
• Other Study ID Numbers: LS-SCLC-MT-IIT-SHR1316

Drug and device information, study documents

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