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

Phase 1

• Conditions: Extensive Stage Small Cell Lung Cancer
• Interventions: Drug: Camrelizumab; apatinib; carboplatin; etoposide

• Registration Number: NCT05001412
• Lead Sponsor: Zhou Chengzhi

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-27
• Study First Submitted: 2021-07-22
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-04
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12
• Primary Completion: 2023-01-25
• Study Completion: 2024-01-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort one	Camrelizumab; apatinib; carboplatin; etoposide	Extensive SCLC patients who are Peripheral type or tumor vascular invasion grade one or less.
Cohort two	Camrelizumab; apatinib; carboplatin; etoposide	Extensive SCLC patients who are central type or tumor vascular invasion grade two to three.

Primary Outcome Measures

Name	Time	Method
Safety: Dose-limiting toxicities	Followed up every 3 weeks.	Any level 4 or greater hematologic toxicity and any level 3 or greater non-hematologic toxicity (accroding to CTC AE 5.0)

Secondary Outcome Measures

Name	Time	Method
12 months OS	Followed up by telephone every 2 months	12 months overall survival
PFS	Imageological diagnosis every 6 weeks	Progression Free Survival

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China