Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of ES-SCLC

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

Clinical Study of Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of Extensive Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001412
• Other study ID #: CROC-2021
• Status: Recruiting
• Phase: Phase 1
• Start date: January 27, 2021
• Est. completion date: January 25, 2024

Study information

• Verified date: August 2021
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Chengzhi Zhou, MD
• Phone: 13560351186
• Email: doctorzcz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy of PD-1/PD-L1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. PD-1/PD-L1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy.

Description:

Camrelizumab is a humanized PD-1 monoclonal antibody. Camrelizumab combined with the antiangiogenic drug apatinib has achieved good efficacy in extensive small-cell lung cancer. Median OS is 8.4 months. In our study, subjects with extensive stage small cell lung cancers receive 2 cycles of chemotherapy followed by carrizumab combined with apatinib and chemotherapy. we hope to achieve a better outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. Extensive stage small cell lung cancer proved by pathology.

• 2. Extensive small cell lung cancer does not receive systematic treatment.

• 3. limited SCLC patients have received radiotherapy and chemotherapy for more than 6 months.

• 4. patients have measurable lesions according to RECIST version 1.1.

• 5. Male or female who is 18 to 75 years old.

• 6. ECOG PS 0 or 1.

• 7. Life expectancy is more than12 weeks.

• 8. Appropriate organ system function.

• 9. hyroid-stimulating hormone is ULN or less (If T3 and T4 is normal, he still meets the Inclusion Criteria even the abnormal TSH. )

• 10. Take proper contraceptive measures.

• 11. Subjects voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

• 1. Previous treatment with apatinib, anti-programmed cell death (PD-1), anti-PD-1, or other PD-1/ PD-L1 immunotherapy.

• 2. Cancer meningitis.

• 3. patients had been diagnosed and/or treated for other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.

• 4. There are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc..

• 5. Uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage.

• 6. Patients with spinal cord compression who were not cured or relieved by surgery and/or radiotherapy, or who were diagnosed with spinal cord compression after treatment and without clinical evidence of stable disease =1 week before enrollment;

• 7. Patients with hypertension who cannot be well controlled by oral antihypertensive therapy, suffer from myocardial ischemia or myocardial infarction of grade I or above, arrhythmias of grade I or above , or cardiac insufficiency;

• 8. Subjects had signs of bleeding, hemoptysis, or a history of unhealed wounds, ulcers, fractures within 2 months prior to initial administration.

• 9. The adverse events caused by previous treatment did not completely recover.

• 10. Patients with major surgery or obvious traumatic injury within 28 days before enrollment;

• 11. Occurred arterial or venous thromboembolism events within 6 months.

• 12. People with a history of drug abuse or mental disorders.

• 13. Suffering from a serious and/or uncontrollable disease;

• 14. Vaccination or attenuated vaccine received within 4 weeks.

• 15. Severe allergies that require treatment with other monoclonal antibody drugs;

• 16. Active autoimmune disease requiring systemic treatment within 2 years prior to the first administration;

• 17. Immunosuppressive therapy with systemic or absorbable local hormones and continued for 2 weeks after the first dose;

• 18. Participate in other anticancer drug clinical trials within 4 weeks;

• 19. In the investigator's judgment, there are other factors that may have led to the termination of the study.

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Camrelizumab; apatinib; carboplatin; etoposide
2 cycle chemotherapy (carboplatin and etoposide), and then 2 cycle chemotherapy (carboplatin and etoposide) combine with Camrelizumab and apatinib, finally maintenance therapy with Camrelizumab and apatinib

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhou Chengzhi	Jiangsu Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Dose-limiting toxicities	Any level 4 or greater hematologic toxicity and any level 3 or greater non-hematologic toxicity (accroding to CTC AE 5.0)	Followed up every 3 weeks.
Secondary	PFS	Progression Free Survival	Imageological diagnosis every 6 weeks
Secondary	12 months OS	12 months overall survival	Followed up by telephone every 2 months