A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-11

Study Completion Date

2022-01-15

Brief Summary

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This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer

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Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental A (part 1) : Fluzoparib + temozolomide

Group Type EXPERIMENTAL

Fluzoparib

Intervention Type DRUG

Given PO

temozolomide

Intervention Type DRUG

Given PO

Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316

Group Type EXPERIMENTAL

Fluzoparib

Intervention Type DRUG

Given PO

temozolomide

Intervention Type DRUG

Given PO

SHR-1316

Intervention Type BIOLOGICAL

Given injection

Interventions

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Fluzoparib

Given PO

Intervention Type DRUG

temozolomide

Given PO

Intervention Type DRUG

SHR-1316

Given injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.
2. Failed one prior line of platinum-based chemotherapy.
3. Subjects must have measurable disease, at least one lesion, by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior to administration of study treatment) ;
4. Freshly acquired samples or archived specimens within 12 months before randomization must be provided.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Participant must have a life expectancy ≥ 12 weeks.

Exclusion Criteria

1. Active or untreated central nervous system (CNS) metastases.
2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
3. History of autoimmune disease.
4. Positive test result for human immunodeficiency virus (HIV).
5. Active hepatitis B or hepatitis C.
6. Severe infections.
7. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.
8. Significant cardiovascular disease.
9. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No