Non Squamous Non Small Cell Lung Cancer
Conditions
Brief summary
The objective of this bridging study is to acquire new drug approval in Korea for camrelizumab (SHR-1210), a drug that has already been approved in China for treatment in patients with histologically or cytologically confirmed advanced or metastatic (Stage IIIB-IV), EGFR/ALK wild-type, non-squamous, non-small cell lung cancer. In this study, subjects with advanced or metastatic, EGFR/ALK wild-type, non-squamous, non-small lung cancer will receive anti-PD-1 antibody therapy of camrelizumab in combination with pemetrexed + carboplatin as first-line treatment for at least 8 cycles (24 weeks). Then, the best overall RECIST responses (BOR) from subjects who have had at least 1 post-baseline tumor assessment will be evaluated to confirm that camrelizumab, a drug that has already been approved China, has similar efficacy in the Korean population as in the Chinese population.
Interventions
DRUGCamrelizumab (SHR-1210), Pemetrexed, and Carboplatin
* 200 mg of Camrelizumab (SHR-1210) is administered intravenously over a period of around 20-60 min on Day 1 of each 3-week cycle. * Pemetrexed 500 mg/m2 is administered intravenously on Day 1 of each 3-week cycle, over a period of more than 10 minutes * Carboplatin of AUC 5 is administered intravenously on Day 1 of each 3-week cycle (hydrated as appropriate), over a period of more than 30 minutes by 4-6 cycles.
Sponsors
CrystalGenomics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject aged between 19-80 at the time of signing the informed consent form, male or female. 2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC), Stage IIIB-IV (as per the International Association for the Study of Lung Cancer (IASLC) Staging Handbook in Thoracic Oncology, 8th Edition). 3. The site must provide documented information on EGFR mutation and ALK translocation and both must be negative. Subject cannot be randomized before receiving the source document for EGFR mutation and ALK translocation. 4. A tumor tissue specimen collected upon or after diagnosis of advanced or metastatic disease, either fresh or archival (within 6 months prior to the first dose), must be provided. At least 10 unstained slides can be generated from the formalin fixed, paraffin-embedded (FFPE) tumor tissue block for immunohistochemistry assay or biomarker testing (or may be less than 10 slides as approved by the sponsor's medical monitor). Specimen obtained from fine needle aspiration, pleural fluid smear, or drill biopsy are unacceptable. For bone lesions, specimen without soft tissue components or decalcified bone tumor specimen is also unacceptable. 5. Subjects who have not previously received systemic chemotherapy for advanced/metastatic NSCLC. Chemotherapy as neo-adjuvant/adjuvant therapy or chemoradiotherapy is permitted, as long as the treatment has been completed at least 12 months before the diagnosis of advanced or metastatic disease. 6. Radiographically measurable lesions via CT or MRI, as per RECIST 1.1. The tumor assessment of baseline should be performed within 28 days prior to the first dose. 7. ECOG PS score: 0-1. 8. Expected survival ≥ 3 months. 9. Subjects must undergo all screening laboratory tests as per the protocol within 14 days prior to the first dose. Laboratory tests at screening must meet the following criteria: 1\) Hematology: (without blood transfusion, G-CSF, or medication within 14 days prior to screening) 1. Hemoglobin (HB) ≥ 90 g/L; 2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; 3. Platelet (PLT) ≥ 100 x 109/L; 4. White blood cell (WBC) ≥ 4.0 x 109/L and ≤ 15 x 109/L; 2) Biochemistry: (no blood or albumin transfusion within 14 days prior to screening) 5. AST and ALT ≤ 1.5 x ULN (≤ 5 x ULN for liver metastasis); 6. ALP ≤ 2.5 x ULN (≤ 5 x ULN for bone metastasis); 7. TBIL ≤ 1.5 x ULN; 8. ALB ≥ 30 g/L; 9. Cr ≤ 1.5 x ULN, and creatinine clearance (CrCL) ≥ 60 mL/min (Cockcroft-Gault equation); 10. APTT ≤ 1.5 x ULN, and INR or PT ≤ 1.5 x ULN (no anticoagulant therapy). 10\. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use adequate method of contraception during the study period and 180 days after the last dose of study medication. 11\. Subject has voluntarily agreed to participate by giving written informed consent/assent.
Exclusion criteria
1\.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall RECIST response, BoR | up to 8 cycles (24 weeks) of the last subject |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | 6 months, 12 months, 24 months |
| Objective response rate (ORR) | 6 months, 12 months, 24 months |
| Overall survival (OS) | up to 6 months from the last visit of the last patient |
| Disease control rate (DCR) | 6 months, 12 months, 24 months |
Countries
South Korea
Contacts
Primary ContactKyung Hye Kim
Outcome results
None listed