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

NCT ID: NCT04672928

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2023-01-31

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.

Conditions

Small Cell Lung Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI318 in combination with paclitaxel

Group Type: EXPERIMENTAL

paclitaxel

Intervention Type: DRUG

80mg/m\^2,iv,Q4W

IBI318

Intervention Type: DRUG

300mg,iv,Q4W

Interventions

paclitaxel

80mg/m\^2,iv,Q4W

Intervention Type: DRUG

IBI318

300mg,iv,Q4W

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Cheng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Jilin Povince Cancer Hospital

Locations

Jilin Povince Cancer Hospital

Changchun, Jilin, China

Countries

China

Other Identifiers

CIBI318C302

Identifier Type: -

Identifier Source: org_study_id