What is camrelizumab studying for non-squamous non-small cell lung cancer?

Camrelizumab is being studied in combination with pemetrexed and carboplatin to evaluate its effect as a first-line treatment for advanced or metastatic non-squamous non-small cell lung cancer. The study aims to confirm how this treatment works in the Korean population compared to previous results in China. The trial is sponsored by CrystalGenomics, Inc.

Who may be eligible for this non-squamous non-small cell lung cancer clinical trial?

Adults aged 19 to 80 years with advanced or metastatic non-squamous non-small cell lung cancer who have negative EGFR mutation and ALK translocation tests may be eligible. Participants must have measurable tumors, good performance status, and no prior systemic chemotherapy for advanced disease. Please review eligibility criteria for more details.

Is there any cost to participate in this non-squamous non-small cell lung cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any out-of-pocket costs.

Actively Recruiting

Phase 2

Age: 19Years - 80Years

All Genders

ID05841472

Study of Camrelizumab with Pemetrexed and Carboplatin as First Treatment for Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer in Adults

Led by CrystalGenomics, Inc. · Updated on 2023-08-30

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to gain approval in Korea for camrelizumab SHR-1210, a drug already approved in China, for treating patients with advanced or metastatic non-squamous non-small cell lung cancer NSCLC that is EGFRALK wild-type. The study focuses on patients with Stage IIIB-IV NSCLC to confirm camrelizumabs effectiveness in the Korean population by comparing tumor responses. Participants will receive camrelizumab combined with pemetrexed and carboplatin as first-line treatment. Camrelizumab 200 mg is given intravenously on Day 1 of each 3-week cycle for at least 8 cycles 24 weeks. Pemetrexed and carboplatin are also administered intravenously on Day 1 of each cycle, with carboplatin given for 4-6 cycles. This treatment plan aims to study the overall tumor response and progression. Throughout the study, participants undergo tumor assessments using RECIST criteria at regular intervals to measure the best overall response. Additional outcomes include progression-free survival, overall survival, objective response rate, and disease control rate over various time points. Safety and lab tests are performed before treatment, and participants are monitored through the treatment period and up to 6 months after the last visit, with an expected survival of at least 3 months.

CONDITIONS

Brief 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

Age: 19Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Aged between 19 and 80 years at 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 status.
Provide tumor tissue specimen collected upon or after diagnosis of advanced or metastatic disease (fresh or archival within 6 months).
No prior systemic chemotherapy for advanced/metastatic NSCLC; prior adjuvant/neoadjuvant chemotherapy allowed if completed at least 12 months before advanced disease diagnosis.
Radiographically measurable lesions via CT or MRI within 28 days before first dose.
ECOG performance status score of 0 or 1.
Expected survival of at least 3 months.
Meet specific laboratory test criteria within 14 days before first dose.
Female subjects of childbearing potential must have a negative pregnancy test and agree to contraception; male subjects with partners of childbearing potential must agree to contraception.
Voluntary written informed consent given.

You will not qualify if you...

Histological types other than non-squamous NSCLC, including mixed carcinomas or NSCLC with small cell or neuroendocrine components.
Presence of EGFR mutation or ALK translocation.
No measurable lesions by imaging.
Carcinomatous meningitis or spinal cord compression.
Untreated central nervous system metastases; treated CNS metastases must be stable and meet specific corticosteroid requirements.
Candidates for surgical resection or radical radiotherapy.
Previous treatment with anti-PD-1(L1) or CTLA4 monoclonal antibodies.
Active or suspected autoimmune diseases requiring systemic immunosuppressants.
Use of systemic corticosteroids (>10 mg prednisone or equivalent) or other immunosuppressants within 14 days before first dose.
Previous cancer vaccines or immunostimulatory agents within 1 month before first dose.
Participation in other investigational agent studies within 4 weeks before first dose.
Expected need for other anticancer treatments during study.
Recent major surgery or radiation therapy without recovery to grade ≤1 toxicity.
Interstitial lung disease or severe lung diseases affecting pulmonary function.
Concomitant active malignant tumors.
History of prior malignant tumors except specific cases in remission.
Significant cardiac conditions or recent myocardial ischemia.
Significant bleeding or thrombosis events within specified timeframes.
Active pulmonary tuberculosis or recent history within 1 year.
Serious infections within 4 weeks before first dose.
Tissue or organ transplant recipients.
Recent live vaccinations within 30 days before first dose.
Contraindications to platinum-based medications.
Uncontrolled tumor-related pain or unstable pain medication regimen.
HIV positive or AIDS.
Untreated active hepatitis B or C infections.
Uncontrolled pleural, pericardial effusion, or ascites.
Severe allergies or intolerances to study drugs or their premedications.
Mental illness, substance abuse, or other disorders interfering with trial cooperation.
Other conditions deemed by investigators to interfere with study or participant safety.

Research Team

Kyung Hye Kim

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Study of Camrelizumab with Pemetrexed and Carboplatin as First Treatment for Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria