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Status unknownNCT04683198Updated Dec 24, 2020

Camrelizumab Combined With Apatinib ,Carboplatin and Etoposide in Participants With ES-SCLC

A Phase 2 interventional study of camrelizumab and Apatinib Mesylate in Small-cell Lung Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-24.

Sponsored by Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study summary

This single-arm, Phase II, multicenter study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 [PD-1] antibody) in combination with Apatinib+carboplatin plus (+) etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be receive camrelizumab +apatinib+ carboplatin + etoposide on 21-day cycles for four -six cycles in the induction phase followed by maintenance with camrelizuab +apatinib until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

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Conditions studied

  • Small-cell Lung Cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 69 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • Eastern Cooperative Oncology Group performance status of 0 or 1;
  • life expectancy≥ 12 weeks
  • Adequate hematologic and organ function
  • Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 72h before the first dose of the study.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • Active autoimmune diseases requiring systemic treatment occurred within 2 years prior to first administration ;
  • Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration;
  • Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism;
  • Within 3 months prior to initial administration, subjects with evidence of bleeding had clinical significance or history of bleeding tendency, regardless of severity;
  • Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration
  • Has major surgical procedure、biopsy or obvious traumatic injury within 28 days before allocation;
  • Has participated in other anticancer drug clinical trials within 4 weeks;
  • Has diagnosed and/or treated additional malignancy within 5 years prior to allocation. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix;
  • Has any severe and/or uncontrolled disease;
  • Has adverse events caused by previous therapy except alopecia that did not recover to ≤ grade 1;
  • Has drug abuse history that unable to abstain from or mental disorders; 13. Has any severe and/or uncontrolled disease;
  • Severe hypersensitivity occurs after administration of other monoclonal antibodies;
  • According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (estimated)

Study arms

  • Experimental
    Experimental: camrelizumab +apatinib+ Carboplatin + Etoposide

    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 .

    Drug: camrelizumab · Drug: Apatinib Mesylate · Drug: Carboplatin · Drug: Etoposide

Interventions

  • Drugcamrelizumab

    Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6) and maintenance phase ,until PD.

    Also known as: SHR-1210

  • DrugApatinib Mesylate

    Apatinib capsules 250 mg given orally , once daily in 21-day cycle and maintenance phase,until PD.

  • DrugCarboplatin

    Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6).

  • DrugEtoposide

    Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6).

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What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).

    Time frame: Baseline until PD or death, whichever occurs first (up to approximately 13 months)

Secondary outcomes

  1. Overall survival (OS)

    Baseline until death from any cause

    Time frame: up to approximately 20 months

  2. Overall response rate (ORR)

    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) .

    Time frame: up to 12 months

  3. Disease control rate (DCR)

    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

    Time frame: up to 12 months

  4. Duration of response(DOR)

    For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first

    Time frame: up to 12 months

  5. PFS rate of 6 months progression-free survival

    PFS rate of progression-free survival at 6 months: the percentage of subjects who did not develop disease progression or die of any cause at 6 months after beganing.

    Time frame: up to 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04683198
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Shi Yuankai (Chief physician, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Dec 24, 2020
Start date
Apr 1, 2021 (estimated)
Primary completion
Oct 30, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Dec 24, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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