Actively Recruiting
Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Led by CrystalGenomics, Inc. · Updated on 2023-08-30
60
Participants Needed
8
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 19 and 80 years at the time of informed consent, male or female
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer, Stage IIIB-IV
- Documented negative EGFR mutation and ALK translocation
- Provide tumor tissue specimen collected within 6 months before first dose, suitable for biomarker testing
- No prior systemic chemotherapy for advanced or metastatic NSCLC; prior adjuvant/neoadjuvant therapy allowed if completed at least 12 months ago
- Radiographically measurable lesions by CT or MRI within 28 days before first dose
- ECOG Performance Status 0-1
- Expected survival of at least 3 months
- Meet required laboratory test criteria within 14 days before first dose
- Female subjects of childbearing potential must have negative pregnancy test within 3 days before first dose
- Agree to use effective contraception during study and for 180 days after last dose
- Provide written informed consent
You will not qualify if you...
- Histological types other than non-squamous NSCLC, including mixed carcinomas or neuroendocrine differentiation
- Presence of EGFR mutation or ALK translocation
- No radiographically measurable lesions
- Carcinomatous meningitis or spinal cord compression
- Untreated central nervous system metastasis; treated CNS metastasis must be stable and meet specific criteria
- Candidates for surgical resection or radical radiotherapy
- Prior treatment with anti-PD-1(L1) or CTLA4 monoclonal antibodies
- Active or suspected autoimmune diseases requiring systemic immunosuppressants
- Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) within 14 days before first dose
- Recent cancer vaccines or immunostimulatory agents within 1 month before first dose
- Participation in other investigational studies with treatment within 4 weeks prior to first dose
- Expected need for other anti-cancer treatments during study
- Recent major surgery or radiation therapy with unresolved toxicities
- Interstitial lung disease or moderate to severe lung diseases affecting lung function
- Concurrent active malignant tumors
- History of prior malignant tumors except certain types with complete remission for at least 5 years
- Significant cardiac conditions including ischemia, infarction, or poor left ventricular function
- Significant bleeding or hemorrhagic tendency within 1 month prior to randomization
- Recent arterial or venous thrombosis within 3 months prior to randomization
- Active pulmonary tuberculosis or recent history within 1 year
- Serious infections within 4 weeks prior to first dose
- Prior or planned tissue/organ transplants
- Live vaccines within 30 days prior to first dose
- Contraindications to platinum-based chemotherapy
- Uncontrolled tumor-related pain or unstable pain medication regimen
- History of HIV/AIDS, untreated active hepatitis, or uncontrolled effusions
- Severe allergies to study drugs or infusion reactions
- Mental illness, substance abuse, or other conditions interfering with study cooperation
- Any condition that may confound study results or interfere with procedures, as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Korea University Anam Hospital
Anam, South Korea
Actively Recruiting
2
Hallym University Sacred Heart Hospital
Anyang, South Korea
Actively Recruiting
3
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Actively Recruiting
4
Catholic University of Korea EunPyeong St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
5
Catholic University of Korea Yeouido St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
6
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
7
Seoul Asan Hospital
Seoul, South Korea
Actively Recruiting
8
Busan National University Hospital Yangsan
Yangsan, South Korea
Actively Recruiting
Research Team
K
Kyung Hye Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here