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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

NCT05841472 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

  • Non Squamous Non Small Cell Lung Cancer

Interventions

DRUG

Camrelizumab (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 & Collaborators

  • CrystalGenomics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sung Yong Lee, MD · Korea University Guro Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841472 on ClinicalTrials.gov