NCT04672928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

December 10, 2020

Last Update Submit

February 23, 2023

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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.

    3 months

  • Objective remission rate

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

    12 months

Secondary Outcomes (5)

  • Continuous remission time (DOR)

    12 months

  • Disease Control Rate (DCR)

    12 months

  • Time to response (TTR)

    12 months

  • Progression-free survival (PFS)

    12 months

  • Overall survival (OS)

    12 months

Study Arms (1)

IBI318 in combination with paclitaxel

EXPERIMENTAL
Drug: paclitaxelDrug: IBI318

Interventions

paclitaxelDRUG

80mg/m\^2,iv,Q4W

IBI318 in combination with paclitaxel
IBI318DRUG

300mg,iv,Q4W

IBI318 in combination with paclitaxel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jilin Povince Cancer Hospital

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Ying Cheng, Ph.D

    Jilin Povince Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2020

First Posted

December 17, 2020

Study Start

December 14, 2020

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

CN(1)