A Phase II Study of Ivonescimab Combined with Cadonilimab and Chemotherapy in Extensive-stage Small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

The goal of this clinical trial is to investigate the efficacy, safety and tolerability of Ivonescimab combined with Cadonilimab and chemotherapy in extensive-stage small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of Ivonescimab combined with Cadonilimab for extensive-stage small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent must be obtained before implementing any trial-related procedures;

Aged 18-80 years;

Expected survival of more than 3 months;

histologically or cytologically confirmed ES-SCLC according to the American Veterans Cancer Association VALG staging system;

Disqualifiers

Currently participating in interventional clinical research treatment;

Imaging during the screening period showed that the tumor was surrounded by important blood vessels or had obvious necrosis or cavities, and the investigator judged that the entry of the study would cause bleeding risk.

active autoimmune disease requiring systemic treatment within the past 2 years (e.g., with disease-modifying medications, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a systemic treatment.

history of noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoid treatment or current noninfectious pneumonia.

Trial design

Design model

Single group

Treatments tested in this trial

  • Arm 1

    Drug

    Ivonescimab combined with Cadonilimab plus EC

  • second-line group

    Drug

    AK112+AK104+paclitaxel

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Arm1Experimental treatment 1 intervention
Group B: Arm2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month Progression-Free Survival (PFS) rate

The 6-month Progression-Free Survival (PFS) rate refers to the proportion of patients who are alive and without disease progression six months after starting treatment.

Time frame
6-month

Secondary outcomes

1

Progression-free Survival

Progression-free survival measures the length of time during and after treatment that a patient lives with the disease without it progressing.

Time frame
up to 60 months
2

objective response rate

Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.

Time frame
up to 24 months
3

Overall Survival

Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients\' lives.

Time frame
up to 100 months
4

duration of response

Duration of response refers to the length of time during which a patient\'s tumor remains in remission or shows a positive response to treatment.

Time frame
up to 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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