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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04884009
Collaborator
(none)
106
Enrollment
2
Arms
19
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
SHR-1701 in combination with or without famitinibSHR-1701 in combination with or without famitinib
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
May 31, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR-1701+ Famitinib

Drug: SHR-1701； Famitinib
SHR-1701+ Famitinib
Experimental: SHR-1701

Drug: SHR-1701
SHR-1701

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) based on RECIST 1.1 criteria [up to approximately 1 year.]

Secondary Outcome Measures

  1. Progression free survival (PFS) based on RECIST 1.1 criteria [up to approximately 1 year.]

  2. Disease control rate (DCR) based on RECIST 1.1 criteria [up to approximately 1 year.]

  3. Duration of response (DoR) [up to approximately 1 year]

  4. Overall survival (OS) [up to approximately 1 year]

  5. AEs+ SAEs determined by NCI-CTCAE V5.0 [Baseline until up to 90 days after end of treatment.]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04884009
Other Study ID Numbers:
  • SHR-1701-II-209
First Posted:
May 12, 2021
Last Update Posted:
May 12, 2021
Last Verified:
May 1, 2021
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 May 12, 2021