Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer

NCT04506242 | Unknown Phase 2

• 1 other identifier: NSCLC-II-006
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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).

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR) Rate

  mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy

  Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12)

Secondary Outcomes (5)

• Pathological Complete Response (pCR) Rate

  Up to 8weeks following completion of neoadjuvant treatment (up to Study Week 12)

• Event Free Survival (EFS)

  up to 5 years

• Objective Response (OR)

  up to 6 weeks

• Disease-Free Survival (DFS)

  up to 5 years

• Adverse Events (AEs)

  up to 17 weeks

Study Arms (1)

apatinib+ Neoadjuvant/Adjuvant camrelizumab

EXPERIMENTAL

Neoadjuvant: Prior to surgery, participants receive 3 cycles (cycle length: 2 weeks) of camrelizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with apatinib ,5 days on 2days off\]. Adjuvant: 4-8 weeks following surgery, participants receive up to 12 cycles (cycle length: 2 weeks) of camrelizumab \[200 mg, IV; given on cycle day 1\]. Participants who can not able to benefit from immunotherapy will not receive camrelizumab adjuvant therapy.

Drug: SHR-1210; Drug: Apatinib

Interventions

SHR-1210 DRUG

PD-1

Also known as: camrelizumab

apatinib+ Neoadjuvant/Adjuvant camrelizumab

Apatinib DRUG

VEGFR2

apatinib+ Neoadjuvant/Adjuvant camrelizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 -70 years, male and female are not limited;
• Patients with ECOG score of 0-1;
• The thoracic surgeon judges the patients without contraindications;
• 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);
• Patients with sufficient lung function;
• 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;
• \. 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.

You may not qualify if:

• Patients with tumor metastasis and known EGFR driving gene mutation;
• Patients who have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, immunotherapy and anti-tumor treatment with traditional Chinese medicine;
• 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;
• Patients with any active autoimmune disease or history of autoimmune disease;
• 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;
• Patients with uncontrollable third cavity effusion, such as massive pleural effusion or ascites or pericardial effusion;
• Routine urine test indicated that urine protein was \>= (+ +), or 24-hour urine protein was \>= 1g, or severe liver and kidney dysfunction;
• 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;
• Patients with other malignant tumors in the past 5 years;
• Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
• Patients with uncontrollable hypertension (systolic blood pressure \>= 140 mmHg or diastolic blood pressure \>= 90 mmHg, despite the best drug treatment);
• Patients with cardiac insufficiency;
• Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.);
• Patients who underwent major surgery, open biopsy or significant trauma within 28 days before admission;
• Patients with hemoptysis, active bleeding, ulcer, intestinal perforation and intestinal obstruction within 3 months before admission;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Interventions

camrelizumab; apatinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 10, 2020
• Study Start: September 15, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2025
• Last Updated: September 9, 2020

Record last verified: 2020-09