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

Phase 1

Completed

• Conditions: Small Cell Lung Carcinoma
• Interventions: Drug: paclitaxel; Drug: IBI318

• Registration Number: NCT04672928
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-10
• Study Start: 2020-12-14
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-17
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI318 in combination with paclitaxel	IBI318	-
IBI318 in combination with paclitaxel	paclitaxel	-

Primary Outcome Measures

Name	Time	Method
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.
Objective remission rate	12 months	Proportion of subjects with complete response (CR) or partial response (PR).

Secondary Outcome Measures

Name	Time	Method
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.
Disease Control Rate (DCR)	12 months	Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
Time to response (TTR)	12 months	Time from randomization to first objective tumor response (CR or PR).
Progression-free survival (PFS)	12 months	Defined as the time from randomization to the first occurrence of objective disease progression or death.
Overall survival (OS)	12 months	Defined as the time from randomization to death due to any cause.

Trial Locations

Locations (1)

Jilin Povince Cancer Hospital; 🇨🇳 Changchun, Jilin, China