RecruitingPhase 2NCT05841472

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

An Open-label, Multi-center, Clinical Study to Evaluate 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

Sponsor

CrystalGenomics, Inc.

Enrollment

60 participants

Start Date

Aug 23, 2023

Study Type

INTERVENTIONAL

Conditions

Non-squamous Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests camrelizumab (an immunotherapy drug) combined with pemetrexed and carboplatin chemotherapy as a first-line treatment for people with advanced non-squamous non-small cell lung cancer — a type of lung cancer. The combination aims to help the immune system attack the cancer while chemotherapy reduces the tumor burden. **You may be eligible if...** - You are 19 to 80 years old with confirmed non-squamous NSCLC at Stage IIIB or IV - Your tumor tests negative for EGFR mutations and ALK gene changes (targeted therapies are more appropriate if positive) - You have not yet received systemic treatment for this advanced stage of lung cancer - You are in good enough health to tolerate combination therapy **You may NOT be eligible if...** - Your cancer has EGFR or ALK gene changes - You have already received chemotherapy or immunotherapy for advanced lung cancer - You have active autoimmune disease or are on immune-suppressing medications - You have serious heart, liver, or lung problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.