Suspended

Camrelizumab and Apatinib Combination Therapy for Untreated Extensive-Stage Small Cell Lung Cancer

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What is being tested

camrelizumab

+ Apatinib Mesylate

+ Carboplatin

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 70 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2021
See protocol details

Summary

Principal SponsorChinese Academy of Medical Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2021

Actual date on which the first participant was enrolled.

This is a treatment-focused, Phase II clinical trial for individuals with untreated extensive-stage small cell lung cancer (ES-SCLC). The main goal is to assess the safety and effectiveness of a combination therapy. This therapy includes Camrelizumab, an anti-programmed death-receptor 1 (PD-1) antibody, along with Apatinib, carboplatin, and etoposide. The importance of this study lies in its potential to find a new treatment approach for ES-SCLC, a condition with significant unmet medical needs. During the study, participants receive the combination therapy in 21-day cycles for four to six cycles, known as the induction phase. This is followed by a maintenance phase with Camrelizumab and Apatinib until progressive disease (PD) is observed. The progression of the disease is evaluated using specific criteria, known as Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). The primary outcome measure is Progression-Free Survival (PFS), which is the time during and after treatment when the patient lives with the disease but it does not get worse.

Official TitleA Single -Arm, Open-label, Multicenter Phase II Study of Camrelizumab Combined With Apatinib ,Carboplatin and Etoposide in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
NCT04683198
Principal SponsorChinese Academy of Medical Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsSmall Cell Lung Carcinoma

Criteria

8 inclusion criteria required to participate
18 and 70 years old
Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system);
No prior systemic treatment for ES-SCLC；
Has received radiotherapy and chemotherapy for limited stage SCLC must have received definitive treatment, and has at least 6 months of no treatment interval from the last treatment to the diagnosis of extensive SCLC
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17 exclusion criteria prevent from participating
Has prior therapy with apatinib,anlotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or other immunotherapy against PD-1/PD-L1;
Has active or untreated central nervous system (CNS) metastases and/or cancerous meningitis;
Has spinal cord compression which was not cured or relieved through surgery and/or radiotherapy, or diagnosed spinal cord compression after treatment showed no clinical evidence of disease stabilization prior to allocation ≥1 week;
Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Induced stage：camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally +Etoposide (100mg/m2 IV continuously on Day 1, 2 and 3）+Carboplatin（AUC 5 mg/mL/min IV on Day 1 ; maintenance stage：Camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally, once daily in 21-day cycle .

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers