Clinical trial NCT04506242: Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer
Official title: Efficacy and Safety of Camrelizumab (SHR-1210) With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer: a Single-Arm, Phase II Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the safety and efficacy of Camrelizumab (SHR-1210) in combination with apatinib neoadjuvant therapy before surgery \[neoadjuvant phase\], followed by camrelizumab alone after surgery \[adjuvant phase\] in participants with resectable stage IIA-IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC).

Detailed description: This trial will evaluate the safety and efficacy of camrelizumab in combination with apatinib neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by camrelizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant camrelizumab in combination with apatinib, followed by surgery and adjuvant camrelizumab will improve: 1)MPR assessed by investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) ; 2) event free survival (EFS) and 3) overall survival (DFS).

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 -70 years, male and female are not limited;
2. Patients with ECOG score of 0-1;
3. The thoracic surgeon judges the patients without contraindications;
4. Patients with early stage non-small cell lung cancer confirmed by histopathology; patients with stage iia-iiib non-small cell lung cancer (IIIB only limited to T3N2), which can be resected radically (according to the 8th edition of the International Association for lung cancer research (IASLC) breast cancer staging manual);
5. Patients with sufficient lung function;
6. Patients who need to obtain tumor tissue for EGFR mutation detection before operation, and no sensitive mutation was found in the EGFR detection results; 7. Patients with measurable target lesions according to the RECIST 1.1 standard;

8. Patients who have not received anti-tumor treatment for NSCLC; 9. Patients with normal function of main organs; 10. The fertile female patients must carry out the serum pregnancy test within 72 hours before the first medication, and the result is negative. The fertile female subjects and the male subjects whose partners are fertile females must agree to use efficient methods of contraception and lactation during the study period and within 90 days after the last administration of the study drug.

Exclusion Criteria:

1. Patients with tumor metastasis and known EGFR driving gene mutation;
2. Patients who have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, immunotherapy and anti-tumor treatment with traditional Chinese medicine;
3. Imaging (CT or MRI) shows that the tumor invades into the large blood vessels or the border with the blood vessels is unclear; or imaging (CT or MRI) shows that there is any pulmonary cavity or necrotic lesions;
4. Patients with any active autoimmune disease or history of autoimmune disease;
5. Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co infection with hepatitis B and hepatitis C;
6. Patients with uncontrollable third cavity effusion, such as massive pleural effusion or ascites or pericardial effusion;
7. Routine urine test indicated that urine protein was \>= (+ +), or 24-hour urine protein was \>= 1g, or severe liver and kidney dysfunction;
8. Subjects requiring systemic treatment with corticosteroids (\> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
9. Patients with other malignant tumors in the past 5 years;
10. Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
11. Patients with uncontrollable hypertension (systolic blood pressure \>= 140 mmHg or diastolic blood pressure \>= 90 mmHg, despite the best drug treatment);
12. Patients with cardiac insufficiency;
13. Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.);
14. Patients who underwent major surgery, open biopsy or significant trauma within 28 days before admission;
15. Patients with hemoptysis, active bleeding, ulcer, intestinal perforation and intestinal obstruction within 3 months before admission;
16. Patients who are taking part in other clinical studies or the time of the first medication is less than 4 weeks from the end of the previous clinical study (the last medication);
17. Patients with severe infection or fever of unknown origin \> 38.5 degrees C within 4 weeks before medication;
18. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
19. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures.

Primary outcomes:
measure: Major Pathological Response (MPR) Rate
timeFrame: Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12)
Secondary outcomes:
measure: Pathological Complete Response (pCR) Rate
timeFrame: Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12)
measure: Event Free Survival (EFS)
timeFrame: up to 5 years
measure: Objective Response (OR)
timeFrame: up to 6 weeks
measure: Disease-Free Survival (DFS)
timeFrame: up to 5 years
measure: Adverse Events (AEs)
timeFrame: up to 17 weeks
Other outcomes:
Locations:
Study officials:
References: