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RecruitingNCT04749394Updated Aug 16, 2022

A Study of Camrelizumab Plus Apatinib as Consolidation Therapy in Non-Small Cell Lung Cancer Patients Treated With Chemoradiotherapy

A Phase 2 interventional study of Camrelizumab, PD-1 monoclonal antibody and Apatinib, VEGFR2 antibody in Locally Advanced Non-Small Cell Lung Cancer, sponsored by Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.

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

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase II, open-Label, multi-centre study to determine the efficacy and safety of Camrelizumab plus apatinib in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based concurrent chemoradiation therapy (cCRT) or sequential chemoradiation therapy (sCRT). This study will be conducted in China mainland.

Read the detailed description

This trial will evaluate the efficacy and safety of camrelizumab plus apatinib in participants with unresectable stage III NSCLC who have not progressed following definitive, platinum-based cCRT or sCRT. The primary endpoint is progression free survival (PFS) in the intent-to-treat (ITT) population. The secondary endpoints are as follows: 1) Overall survival (OS); 2) 1, 2, 3-year OS rates; 3) PFS rates at 12-monthand 18-month; 4) Objective response rate (ORR), 5) Duration of response (DoR); 6) Time to death or distant metastasis (TTDM); 7) Adverse effects (AEs) and severe adverse effects (SAEs) ;8) Quality of life (QoL).Exploratory objective is to explore potential biomarkers associated with efficacy.

02

Conditions studied

  • Locally Advanced Non-Small Cell Lung Cancer

Keywords

  • Non-Small Cell Lung Cancer
  • Programmed cell death 1 (PD-1, PD1)
  • Anti VEGF
  • Chemoradiotherapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients aged ≥18 years, male and female are not limited;
  2. Patients with ECOG score of 0-1;
  3. Life expectancy ≥12 weeks;
  4. Patients must have histologically or cytologicallyproved NSCLC, and present with locally advanced, unresectable Stage III disease(according to 8th AJCC/UICC Classification);
  5. Receipt of concurrent or sequential chemoradiation therapy which must have been completed within 42 days prior to first dose administration of the study; Consolidation chemotherapy is not permitted.
  6. No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy;
  7. Subject with prior anti-cancer treatment can only be enrolled when all toxicities of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1, except for hearing loss, alopecia and fatigue. (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] V5.0);
  8. No prior exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-VEGF treatments, as well as therapeutic anticancer vaccines;
  9. Agreement to provide tumor histological specimens required for this study;
  10. Adequate organ and marrow function required;
  11. Fertile female were required to have a negative serum or urine pregnancy test within 72 days before the start dose of study medication; If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, he must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication or have been surgically sterilized;
  12. Provision of signed ICF.

Exclusion criteria

Exclusion Criteria:

  1. Mixed small cell lung cancer histology;
  2. Disease progression after concurrent/sequential chemoradiotherapy;
  3. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of treatment;
  4. Receipt of live attenuated vaccine within 28 days prior to the first dose of treatment;
  5. Previous enrolment of another study and receiving any study drug within 28 days prior to the first dose of treatment;
  6. Patients with ≥Grade 2 pneumonitis from the prior anti-cancerchemoradiation therapy;
  7. Imaging (CT or MRI) shows the tumor invading large vessels or blurring the boundary with vessels;
  8. History of organ transplant or allogeneic hematopoietic stem cell transplantation;
  9. Patients with any active autoimmune disease or history of autoimmune disease;
  10. Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection;
  11. Uuntreated active hepatitis B or, hepatitis C or active tuberculosis or currently receiving anti-tuberculosis treatment co-infection with hepatitis B and hepatitis C;
  12. Subjects receiving systemic treatment with corticosteroids (>10mg/day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
  13. History of another primary malignancy within 5 years prior to enrollment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
  14. Pulmonary function test: FEV1\< 1.2L or DLCO \< 50% of predicted value;
  15. Patients with cardiac insufficiencyheart diseases including: 1) NYHA III-IV; 2)Acute coronary syndrome; 3) Supraventricular or ventricular arrhythmias requiring clinical intervention; 4) Pericardial and myocardial diseases; 5) Echocardiography indicates that the left ventricular ejection fraction (LVEF) is \< 50%;
  16. Patients with uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite the best drug treatment);
  17. Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including cerebral embolism, deep vein thrombosis, pulmonary embolismcerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.);
  18. Patients with hemoptysis, active bleeding, ulcer, intestinal perforation and intestinal obstruction within 3 months before administration;
  19. Significant hemoptysis symptoms or daily amount of hemoptysis up to 2.5mL or more within 30 days before the first administration;
  20. Known hereditary or acquired bleeding and thrombosis tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
  21. Routine urine test indicated that urine protein was ≥ (++), or 24-hour urine protein was ≥ 1g, or severe liver and kidney dysfunction;
  22. Patients with severe infection or fever of unknown origin > 38.5 degrees C within 24 weeks before medication;
  23. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
  24. Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients, apatinib and chemotherapy drugs;
  25. Any conditions, judged by investigators, that may impair the subject or cause the subject to be unable to meet or perform the study requirements.
04

Study design

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

Study arms

  • Experimental
    Experimental Arm

    Camrelizumab plus apatinib as consolidation therapy

    Drug: Camrelizumab, PD-1 monoclonal antibody · Drug: Apatinib, VEGFR2 antibody

Interventions

  • DrugCamrelizumab, PD-1 monoclonal antibody

    Camrelizumab 200mg IV, Q3W, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.

    Also known as: SHR-1210

  • DrugApatinib, VEGFR2 antibody

    Apatinib 250mg PO, QD, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.

    Also known as: Apatinib Mesylate

05

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS)

    PFS is determined by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

    Time frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months)

Secondary outcomes

  1. Overall Survival (OS)

    OS is defined as the first date of treatment to date of death from any causes.

    Time frame: up to approximately 36 months

  2. PFS at 12 months (PFS12)

    PFS will be calculated using Kaplan-Meier product limit methods.

    Time frame: up to maximum 12 months

  3. PFS at 18 months (PFS18)

    PFS will be calculated using Kaplan-Meier product limit methods.

    Time frame: up to maximum 18 months

  4. OS at 12 months (OS12)

    OS will be calculated using Kaplan-Meier product limit methods.

    Time frame: up to maximum 12 months

  5. OS at 24 months (OS24)

    OS will be calculated using Kaplan-Meier product limit methods.

    Time frame: up to maximum 24 months

  6. OS at 36 months (OS36)

    OS will be calculated using Kaplan-Meier product limit methods.

    Time frame: up to maximum 36 months

  7. Objective response rate (ORR)

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.

    Time frame: up to approximately 24 months

  8. Duration of Response (DoR)

    DoR is defined as the first date of treatment to the progression, or the last evaluable assessment in the absence of progression.

    Time frame: up to approximately 24 months

  9. TTDM

    TTDM is defined as the first date of treatment to the first date of distant metastasis or death in the absence of distant metastasis.

    Time frame: up to approximately 36 months

  10. Number of participants with AEs, SAEs, Treatment-related Adverse Events (TRAEs).

    Time frame: From screening (Day -28) till final visit (up to a maximum of 24 months)

06

Study locations

1 of 1 sites recruiting
  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, 100021, China
    • Zhouguang Hui, M.D. · Contact · drhuizg@163.com · 8610-87787230
    • Zhouguang Hui, M.D. · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04749394
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Zhouguang Hui, M.D. (Chief physician, Director of VIP Department, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Feb 11, 2021
Start date
Mar 17, 2021
Primary completion
Jan 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Aug 16, 2022

Study contacts

Zhouguang Hui
Contact
drhuizg@163.com
18611876792
Yirui Zhai
Contact
januarywind@163.com
18610168510

Oversight

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

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