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

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672928
• Other study ID #: CIBI318C302
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

Intervention

Drug:
• paclitaxel
80mg/m^2,iv,Q4W
• IBI318
300mg,iv,Q4W

Locations

Country	Name	City	State
China	Jilin Povince Cancer Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Objective remission rate	Proportion of subjects with complete response (CR) or partial response (PR).	12 months
Secondary	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.	12 months
Secondary	Disease Control Rate (DCR)	Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).	12 months
Secondary	Time to response (TTR)	Time from randomization to first objective tumor response (CR or PR).	12 months
Secondary	Progression-free survival (PFS)	Defined as the time from randomization to the first occurrence of objective disease progression or death.	12 months
Secondary	Overall survival (OS)	Defined as the time from randomization to death due to any cause.	12 months