Combining Camrelizumab and Apatinib for Lung Cancer Treatment

A Phase II, Open-Label, Multi-Centre Study of Camrelizumab Plus Apatinib As Consolidation Therapy in Patients With Locally Advanced, Unresectable NSCLC, Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy

This study is testing if combining two drugs, camrelizumab and apatinib, can help people with advanced lung cancer live longer and feel better after their initial treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ChineseAMS
• Drugs / interventions: camrelizumab, apatinib, chemotherapy, prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT04749394 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates the effectiveness and safety of camrelizumab, a PD-1 monoclonal antibody, combined with apatinib, a VEGFR2 antibody, in patients with unresectable Stage III non-small cell lung cancer (NSCLC) who have not progressed after receiving platinum-based chemoradiotherapy. The study aims to assess progression-free survival as the primary endpoint, along with overall survival and various other secondary outcomes. Conducted in mainland China, the trial will also explore potential biomarkers related to treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable Stage III NSCLC who have recently completed chemoradiotherapy without disease progression.

Not a fit: Patients with prior exposure to anti-CTLA-4 or anti-PD-1 therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced lung cancer.

How similar studies have performed: Previous studies combining immunotherapy with targeted therapy in lung cancer have shown promising results, suggesting potential success for this approach.

Eligibility criteria

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:

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.

Where this trial is running

Beijing

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zhouguang Hui

Conditions Locally Advanced Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; Programmed cell death 1; Anti VEGF; Chemoradiotherapy