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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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04672928
Collaborator
(none)
20
Enrollment
2
Locations
1
Arm
34.4
Anticipated Duration (Months)
10
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Dec 21, 2020
Anticipated Primary Completion Date :
May 25, 2023
Anticipated Study Completion Date :
Nov 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: IBI318 in combination with paclitaxel

Drug: paclitaxel
Paclitaxel injection

Biological: IBI318
lBI318 injection

Outcome Measures

Primary Outcome Measures

  1. Adverse events [3 months]

    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.

  2. Objective remission rate [12 months]

    Proportion of subjects with complete response (CR) or partial response (PR).

Secondary Outcome Measures

  1. Continuous remission time (DOR) [12 months]

    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.

  2. Disease Control Rate (DCR) [12 months]

    Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).

  3. Time to response (TTR) [12 months]

    Time from randomization to first objective tumor response (CR or PR).

  4. Progression-free survival (PFS) [12 months]

    Defined as the time from randomization to the first occurrence of objective disease progression or death.

  5. Overall survival (OS) [12 months]

    Defined as the time from randomization to death due to any cause.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Hospital Chinese Academy of Medical Sciences. Beijing China
2 Jilin Cancer Hospital Jilin China

Sponsors and Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Investigators

  • Principal Investigator: Ying Cheng, Jilin Provincial Tumor Hospital
  • Principal Investigator: Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT04672928
Other Study ID Numbers:
  • CIBI318C302
First Posted:
Dec 17, 2020
Last Update Posted:
Dec 28, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Paclitaxel

Study Results

No Results Posted as of Dec 28, 2020