A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer

May 7, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure

The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
  2. 18 to 75 years old, male or female.
  3. Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
  4. ECOG Performance Status of 0 or 1.
  5. Adequate hematological, hepatic and renal function.
  6. Female subjects of child-bearing potential must have a negative serum HCG test before treatment.

Exclusion Criteria:

  1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
  2. Untreated central nervous system metastases.
  3. Cancerous meningitis (meningeal metastasis).
  4. Uncontrolled pleural effusion, pericardial effusion or ascites.
  5. Tumor infiltration into the great vessels on imaging;
  6. Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
  7. Uncontrolled tumor-related pain.
  8. Malignancies other than SCLC within 5 years.
  9. Systemic antitumor therapy was received 4 weeks prior to trial treatment.
  10. History of autoimmune diseases.
  11. Significant cardiovascular disease.
  12. Inadequately controlled hypertension.
  13. Known history of testing positive test for HIV or known AIDS.
  14. Patients with active hepatitis B or hepatitis C
  15. Severe infections within 4 weeks prior to trial treatment.
  16. Active tuberculosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-1701+ Famitinib
Drug: SHR-1701； Famitinib
SHR-1701+ Famitinib
Experimental: SHR-1701
Drug: SHR-1701
SHR-1701

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) based on RECIST 1.1 criteria
Time Frame: up to approximately 1 year.
up to approximately 1 year.

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS) based on RECIST 1.1 criteria
Time Frame: up to approximately 1 year.
up to approximately 1 year.
Disease control rate (DCR) based on RECIST 1.1 criteria
Time Frame: up to approximately 1 year.
up to approximately 1 year.
Duration of response (DoR)
Time Frame: up to approximately 1 year
up to approximately 1 year
Overall survival (OS)
Time Frame: up to approximately 1 year
up to approximately 1 year
AEs+ SAEs determined by NCI-CTCAE V5.0
Time Frame: Baseline until up to 90 days after end of treatment.
Baseline until up to 90 days after end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 31, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1701-II-209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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