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A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies

Primary Purpose

Small Cell Lung Carcinoma

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
paclitaxel
IBI318
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed the Informed Consent Form;
  2. Male or female ≥ 18 and≤75 years of age;
  3. Life expectancy ≥ 12 weeks;
  4. Pathologically confirmed limited or extensive stage small cell lung cancer according to Veterans Lung Administration Lung Study Group (VALG) staging;
  5. At least had progressive disease during or after platinum-based first-line chemotherapy or chemoradiotherapy, and with clear evidence of radiographic progression.

Exclusion Criteria:

  1. Previous exposure to immune-mediated therapy; previous use of taxane chemotherapy;
  2. Received the last anti-tumor therapy (chemotherapy, radiotherapy) within 4 weeks prior to the first dose of study drug;
  3. Received any investigational agent within 4 weeks prior to the first dose of study drug;
  4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
  5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
  6. Pregnant or breastfeeding woman.

Sites / Locations

  • Jilin Povince Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IBI318 in combination with paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

Adverse events
The incidence rate of all treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs) and serious adverse events (SAEs), treatment-related adverse events (TRAEs) and the severity.
Objective remission rate
Proportion of subjects with complete response (CR) or partial response (PR).

Secondary Outcome Measures

Continuous remission time (DOR)
For subjects with CR or PR, it is defined as the time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.
Disease Control Rate (DCR)
Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
Time to response (TTR)
Time from randomization to first objective tumor response (CR or PR).
Progression-free survival (PFS)
Defined as the time from randomization to the first occurrence of objective disease progression or death.
Overall survival (OS)
Defined as the time from randomization to death due to any cause.

Full Information

First Posted
December 10, 2020
Last Updated
February 23, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04672928
Brief Title
A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies
Official Title
A Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel versus placebo in combination with paclitaxel in subjects with small cell lung cancer who have failed first-line or above chemotherapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBI318 in combination with paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
80mg/m^2,iv,Q4W
Intervention Type
Drug
Intervention Name(s)
IBI318
Intervention Description
300mg,iv,Q4W
Primary Outcome Measure Information:
Title
Adverse events
Description
The incidence rate of all treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs) and serious adverse events (SAEs), treatment-related adverse events (TRAEs) and the severity.
Time Frame
3 months
Title
Objective remission rate
Description
Proportion of subjects with complete response (CR) or partial response (PR).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Continuous remission time (DOR)
Description
For subjects with CR or PR, it is defined as the time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.
Time Frame
12 months
Title
Disease Control Rate (DCR)
Description
Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
Time Frame
12 months
Title
Time to response (TTR)
Description
Time from randomization to first objective tumor response (CR or PR).
Time Frame
12 months
Title
Progression-free survival (PFS)
Description
Defined as the time from randomization to the first occurrence of objective disease progression or death.
Time Frame
12 months
Title
Overall survival (OS)
Description
Defined as the time from randomization to death due to any cause.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed the Informed Consent Form; Male or female ≥ 18 and≤75 years of age; Life expectancy ≥ 12 weeks; Pathologically confirmed limited or extensive stage small cell lung cancer according to Veterans Lung Administration Lung Study Group (VALG) staging; At least had progressive disease during or after platinum-based first-line chemotherapy or chemoradiotherapy, and with clear evidence of radiographic progression. Exclusion Criteria: Previous exposure to immune-mediated therapy; previous use of taxane chemotherapy; Received the last anti-tumor therapy (chemotherapy, radiotherapy) within 4 weeks prior to the first dose of study drug; Received any investigational agent within 4 weeks prior to the first dose of study drug; Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose; Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study; Pregnant or breastfeeding woman.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Cheng, Ph.D
Organizational Affiliation
Jilin Povince Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jilin Povince Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies

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