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

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04647357
Collaborator
(none)
60
Enrollment
1
Arm
37
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment
Anticipated Study Start Date :
Nov 27, 2020
Anticipated Primary Completion Date :
May 27, 2023
Anticipated Study Completion Date :
Dec 27, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR-1316

Drug: SHR-1316
Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks

Outcome Measures

Primary Outcome Measures

  1. PFS [Up to approximately 24 months]

    progression-free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaorong Dong, Director, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier:
NCT04647357
Other Study ID Numbers:
  • LS-SCLC-MT-IIT-SHR1316
First Posted:
Nov 30, 2020
Last Update Posted:
Nov 30, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma

Study Results

No Results Posted as of Nov 30, 2020