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Completed

NCT Number: NCT04672928

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jilin Povince Cancer Hospital

Changchun, Jilin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

paclitaxel

Drug

80mg/m^2,iv,Q4W

IBI318

Drug

300mg,iv,Q4W

Primary outcomes

  1. Adverse events

    Time frame: 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

    Time frame: 12 months

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

Secondary outcomes

  1. Continuous remission time (DOR)

    Time frame: 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)

    Time frame: 12 months

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

  3. Time to response (TTR)

    Time frame: 12 months

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

  4. Progression-free survival (PFS)

    Time frame: 12 months

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

  5. Overall survival (OS)

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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